Manufacturers of Professional, Personal & Animal …assessments, Robinson Healthcare also uses BSI to independently certify compliance with a number of other very important standards

Manufacturers ofProfessional, Personal &Animal Healthcare Products

Single Use Instruments

Absorbents

Wipes

Woundcare

Patient Identification

First Aid

Cotton Wool

Personal Care

Continence Care

Animal Care

7396 RHC Corporate Brochure_Layout 1 01/09/2011 12:24 Page 2

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1

About Robinson HealthcareRobinson Healthcare has an established reputation as one of the UK’s leading manufacturers ofhealthcare products, providing medical professionals, pharmacists, retailers and consumers withproducts they can trust.

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1839 John Bradbury Robinson begins making pill boxes

1855 Commence manufacturing of surgeon’s lint

1885 Patent and start manufacturing Gamgee®

1885 File world’s first patent for sanitary towels

1880s First antiseptic dressings developed with Lord Lister

1949 Patent Paddi-Pads®, the 1st disposable nappy system

1950s Consumer cotton wool products introduced

1959 Nikini consumer sanitary towels launched

1959 Flexoplast® adhesive plasters introduced

1967 Develop and introduce breast pads

1972 Fast Aid® adhesive plasters introduced

1982 Introduce cotton wool pleats, rolls and balls

1984 Launch Readiwipes® - 1st non-woven patient wipe

2002 Instrapac® single use instruments launched

2010 Launch Instraspec® - 1st unbreakable plastic speculum

A History of Innovation The company was founded in 1839 when John BradburyRobinson, a retail chemist in Chesterfield, Derbyshire, decided toset up a business making pill boxes. 16 years later the businessdiversified and starting manufacturing surgical dressings to meetthe huge demand created by the Crimean War.

The business pioneered the manufacture of medical cotton wooland worked in partnership with Dr Joseph Sampson Gamgee topatent and manufacture the world famous Gamgee® tissue.

Innovation remains part of the company’s product developmentplans today. Robinson Healthcare was a pioneer in theintroduction of single use surgical instruments in 2002 andremains the clear market leader. In 2010, further development ledto the introduction of Instraspec®, the first unbreakable disposableplastic vaginal speculum.

Manufactured in the UKAlmost all Robinson Healthcare products are produced at a largeUK manufacturing facility in Worksop, Nottinghamshire. Single useinstruments, which are classed as medical devices, are checkedand packed in a large Class 7 cleanroom, with in-housesterilisation in a twin chamber steam autoclave.

Cotton wool products are manufactured from raw materialsoffering optimum versatility and rapid response to changes incustomer demand. Robinson Healthcare’s factory is also approvedto manufacture licensed veterinary medicinal products.

These and other products are manufactured for three distinctmarket sectors:

Professional HealthcareA comprehensive range of single use instruments for surgical,gynaecological, podiatry and dental procedures. Complementedby medical cotton wool and absorbents, patient and surface wipesand professional woundcare products.

Personal HealthcareAn extensive choice of innovative first aid products for the home,plus market leading beauty and baby care cotton wool products,breast pads, ear plugs and continence care items.

Animal HealthcareThe UK’s only licensed veterinary poultice dressing complementedby veterinary woundcare and cotton wool products.

Understanding Customer NeedsRobinson Healthcare has over 170 years experience of working inpartnership with healthcare professionals, pharmacists, retailersand consumers. The company fully understands that a consistentand reliable supply of high quality products is critical to thesmooth and efficient running of healthcare services, pharmacy andretail operations.

To maintain this high level of service, Robinson Healthcare has adedicated team that liaises with customers at all levels within eachof the following market sectors:

• NHS & private healthcare

• Nursing and care homes

• Medical distributors

• Retail multiples & high street retailers

• Pharmacists & pharmacy distributors

• Animal healthcare distributors

Extensive stocks of finished goods and raw material underpin thecompany’s supply from stock philosophy, maintaining a world-class level of service.

Core Values and AimsRobinson Healthcare is committed to meeting customers’ needs.To do so, it has adopted a number of core aims and values thatare fundamental to the business:

• Create and maintain partnerships with customers to developopen, long term relationships

• Have a straightforward and honest approach to business

• Continued investment in research and development

• Manufacture products that are safe, effective, value for moneyand produced in full compliance with all appropriate legislationand standards

• Invest in maintaining manufacturing facilities that are first class

• Operate to high environmental and ethical standards

• Invest in training employees

• Listen to customers

The result is a progressive and innovative company whose namecan be trusted – Robinson Healthcare.


Quality, Legislation& Standards

The majority of products manufactured by Robinson Healthcarehave to meet statutory regulations before they can be legallyplaced on the market for sale. This requires considerableinvestment in product development, manufacturing standards andquality management systems, combined with a thoroughunderstanding of regulatory affairs and ongoing marketsurveillance.

For many smaller businesses or overseas manufacturers, thisneed for statutory compliance may not always be fully understoodor may be inadvertently overlooked. At Robinson Healthcare alarge team of specialist staff provide the necessary skills andmany years of experience to ensure products are safe, fit forpurpose and deliver peace of mind to users of the company’sbrands. The most pertinent regulations that Robinson Healthcareproducts adhere to are:

• Medical Devices Directive 93/42/EEC, as amended by2007/47/ECEnacted in UK law by The Medical Devices Regulations 2002,SI 2002/618, as amended by SI 2008/2936. RobinsonHealthcare products include: most medical products such assurgical instruments, absorbents, woundcare, bandages andfirst aid products. Enforced by the Medicines and Healthcareproducts Regulatory Agency (MHRA).

• Cosmetic Products Directive 76/768/EECEnacted in UK law by The Cosmetic Products (Safety)Regulations 2008, SI 2008/1284. Robinson Healthcare productsinclude: personal cleansing wipes. Enforced by the Secretary ofState for Trade and Industry.

• Biocidal Products Directive 98/8/ECEnacted in UK law by The Biocidal Products Regulations 2001,SI 2001/880. Robinson Healthcare products include: surfacecleansing wipes. Enforced by the Health and SafetyExecutive (HSE).

• Veterinary Medicinal Products Directive 2001/82/ECEnacted in UK law by The Veterinary Medicines Regulations2009, SI 2009/2297. Robinson Healthcare products include:veterinary poultice dressings. Enforced by the VeterinaryMedicines Directorate (VMD).

All of these regulations are intended, as appropriate, to ensuresafety for the human or animal that the product is being used on,safety for the user, protection of the environment and efficacy forthe task for which it is intended.

Compliance with legislation and standards is fundamental to Robinson Healthcare’s philosophy in allareas of the business, resulting in high quality products that exceed the appropriate product andmanufacturing standards and meet the rigorous demands of customers, whilst offering exceptional valuefor money.

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Making Products Legal


In order to comply with these various regulations, RobinsonHealthcare has to demonstrate that products are manufactured inaccordance with the European Directives that are harmonised withUK law. Achieving this usually requires that an official body auditthe company’s manufacturing facility. In the majority of cases, theactual product and the associated technical documentation areassessed as part of the auditing process.

Compliance with the Medical Devices Directive is enforced in theUK by the MHRA. This government agency ensures thatmedicines and medical products are fit for their intended purposeand acceptably safe, with far reaching powers to withdrawproducts from the market and prosecute a manufacturer if the lawhas been broken. It does not carry out conformity assessments orissue certification. A Notified Body does this – a certificationorganisation designated by the MHRA to carry out assessments.Robinson Healthcare’s Notified Body is British StandardsInstitution (BSI) based in Milton Keynes, UK. BSI is also theNational Standards Body in the UK.

In addition to using BSI for all medical devices conformityassessments, Robinson Healthcare also uses BSI toindependently certify compliance with a number of other veryimportant standards.

These include

• BS EN ISO 9001:2008 – Quality Management Systemcertification

• BS EN ISO 13485:2003 – Medical Devices QualityManagement System certification

• BS EN ISO 14001:2004 – Environmental ManagementSystem certification

A more detailed explanation of the requirements of the MedicalDevices Directive, the most demanding of the numerousstandards that Robinson Healthcare must comply with, isprovided on page 6.

Quality Standards for Retail ProductsRobinson Healthcare also manufactures a wide range ofconsumer retail products such as cotton wool balls, pleats, rollsand pads, first aid plasters and bandages, breast pads andmaternity briefs. Although these products are not classified asmedical devices, quality and performance is just as important forthe retailers that sell the products and consumers who buy them.

To demonstrate the high level of care that these products aremanufactured to, Robinson Healthcare is independently certifiedto the British Retail Consortium (BRC) Global Standard forConsumer Products. The BRC is the lead trade associationrepresenting the whole range of retailers, from large multiplesthrough to independent stores. It is recognised worldwide as theauthoritative voice of retailers.

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Complying with Regulations

FM12010 MD514840

Continued on page 4


Quality Standards for Retail Products (Cont.)The BRC Global Standards are industry leading technicalstandards that have gained usage worldwide and are generallyspecified as a mandatory requirement for manufacturers supplyingproducts to BRC members. Certification is achieved through auditby a third party certification body. The Consumer Productsstandard focuses on the manufacture of safe and legal consumerproducts of a consistent and required quality. To achieve this, thestandard requires:

• A documented and effective quality management system

• Adoption of a product hazard and risk management system,with appropriate controls

• A policy of continual improvement

• Product and process control, including calibration and foreignbody controls

• Product conformity assessment, including test and evaluation

• Effective control of the manufacturing site environment,including cleanliness, organisation, pest control and wastedisposal

• Appropriate staff training for protective equipment and hygiene

Robinson Healthcare products are classified as Group 1 productswithin the standards. These are products with the highest level ofhygiene risk and need to be made under hygienic conditions.

Robinson Healthcare employs a number of important measures toensure hygienic conditions are maintained. Cotton raw material ispassed through a primary stage multi-phase magnetic removalprocess, to ensure no metal contamination, whilst finishedproduct passes through final stage electronic metal detection forferrous and non-ferrous materials for added safety. All operativeshave to wear hair and beard nets and the wearing of jewellery ormake up is not permitted. The manufacturing facility itself isenclosed to prevent insect contamination and has insectocutorsfor added protection, whilst all light fittings in the production areaare enclosed to prevent any possible glass contamination.

The status of Robinson Healthcare’s certification can be checkedat any time by visiting the BRC Directory atwww.brcdirectory.com.

Good Manufacturing PracticeIn addition to compliance with specific regulations and qualitystandards, Robinson Healthcare’s manufacturing facility alsooperates in compliance with Good Manufacturing Practice (GMP).GMP is defined as “that part of quality assurance which ensuresthat products are consistently produced and controlled to thequality standards appropriate to their intended use.”

GMP is a mandatory requirement for facilities engaged in themanufacture of medicinal products, including veterinary medicinalproducts. For this reason, the section of Robinson Healthcare’sfactory that manufactures Animalintex®, a licensed veterinarymedicinal product, is audited for compliance to GMP by theVeterinary Medicines Directorate. The same principles of GMP areapplied throughout the remainder of the facility. Even though thereis not a mandatory requirement for GMP for medical devices andpersonal healthcare products, this further demonstrates RobinsonHealthcare’s commitment to high quality manufacturing.

The underpinning principles of GMP are similar to, but moredemanding than those required for BRC Global Standards:

• Quality Management System – documented and effective

• Trained Personnel – suitably qualified and continual training

• Premises & Equipment – built and maintained to suit theoperation, correctly cleaned, using calibrated equipment andentry by unauthorised personnel prevented

• Documentation – clearly and unambiguously writtenspecifications, instructions, procedures and records

• Production – performed by trained and competent personnelwith any deviations approved and documented, plus avoidanceof any contamination and regular validation of product tospecification

• Quality Control – full and independent systems at all stages ofproduction

• Complaints and Product Recall – effective review of allcomplaints and a recall system that can be initiated promptly

• Internal Audits – conducted regularly by designated competentpersonnel

Robinson Healthcare makes certification available at all times andinvite customers to inspect their current status directly with any ofthe conformance assessment bodies above.

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Understanding theMedical Devices DirectiveThe Medical Devices Directive 93/42/EEC, as amended by 2007/47/EC, is the most demanding ofregulations that Robinson Healthcare must comply with in order to legally market and sell the wide rangeof medical products that it manufactures. The directive places legal obligations on manufacturers toensure that their devices are safe and fit for their intended purpose.

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Robinson Healthcare products encompassed by the Directiveinclude Instrapac® single use surgical instruments, Instraspec®

disposable vaginal speculums, woundcare dressings, medicalabsorbents, bandages and adhesive plasters.

Legal RequirementsThe Medical Devices Directive is European legislation that isenacted in UK law by The Medical Devices Regulations 2002,Statutory Instrument 2002/618, as amended by SI 2008/2936.This harmonised Directive applies in all countries within theEuropean Union, which means that compliant products identifiedby the CE mark may be traded freely anywhere in the EU. It isillegal to sell a medical device that does not have a CE mark andmeet the requirements of the legislation. However, the presence ofa CE mark is not a guarantee that the product is fully compliant orof an acceptably high quality .

In each country, or member state, a Competent Authority isresponsible for implementing the Directive and ensuring thatmanufacturers comply with the regulations. In the UK theCompetent Authority is the Secretary of State for Health actingthrough the Medicines and Healthcare products RegulatoryAgency (MHRA). The MHRA is also responsible for implementing

The Medicines Act 1968, which provides the legal framework forthe licensing and control of medicines in the UK. Responsibilitiesalso include approvals for manufacturers to carry out clinicalinvestigations and the collection, evaluation and publication ofadverse incident reporting.

Notified BodiesThe Competent Authority designates independent certificationorganisations, called Notified Bodies, that check and certify thatmanufacturers of medical devices comply with the regulations. Amanufacturer can use any Notified Body registered in the EU tocarry out conformity assessment procedures required by theDirective.

Robinson Healthcare uses the internationally respected UKNotified Body, the British Standards Institution (BSI) to carry outconformity assessment of its medical devices. Customerstherefore have the assurance that assessments are being carriedout by a long established and experienced organisation.


The Medical Devices Directive sets out the regulations that haveto be met and how manufacturers must comply. Medical devicesare grouped into four classes, which are subject to different levelsof control to gain compliance. The higher the inherent degree ofrisk to patients or users that a device presents, the higher the levelof control is required for CE marking.

When considering a new product, the manufacturer must firstdetermine whether it is a medical device and if so, which class itbelongs to. This is determined using rules in Annex lX of theDirective. If more than one rule applies to a device, the highestclassification stands.

Every device must meet a number of “Essential Requirements” asstated in Annex l of the Directive. Demonstration that the devicecomplies with these requirements forms part of the technicaldocumentation required for all class of device. Theserequirements cover elements of the design, manufacture andpackaging such as:

• Safety of patients and users

• Eliminating or addressing any risks associated with use of theproduct

• Performance of the device, including over its life period

• Biocompatibility, toxicity and flammability

• Elimination or reduction of any infection risk

• Maintenance of sterility (sterile devices)

• Appropriate environmentally controlled manufacturingconditions

• Accuracy and stability of measuring function (measuringdevices)

• Correct, unambiguous labelling

Routes to ComplianceWhen the classification has been determined and the essentialrequirements addressed, devices then require different levels ofdesign and manufacturing control in order to comply with theDirective. A simplified interpretation of the route, dependent onthe class of device, is provided on pages 8 and 9.

• Class 1 Devices

The least onerous route of conformance is reserved for Class ldevices that are not sterile and do not have a measuring function.Class l devices include products such as absorbents, secondarydressings, bandages and incontinence pads. It also includesreusable surgical instruments. Under Annex Vll, the manufactureris required to prepare detailed technical documentation to supporta self-declaration of conformity. In addition to meeting theessential requirements, the documentation must contain adescription and drawings of the device, the results of risk analysis,design calculations, instructions for use and labelling.

It should be noted that self-declaration of conformity and theaffixing of a CE mark on a Class l device does not need anyinvolvement or authorisation by a Notified Body. Users rely entirelyon the manufacturer’s claims of compliance and therefore arerecommended to satisfy themselves that they are dealing with a

reputable manufacturer that can demonstrate a track record inmanufacturing high quality medical devices. Manufacturers ofClass l devices do, however, have to register their products withthe Competent Authority. For UK based companies, the MHRAhold this register. The current status of a manufacturer’sregistration can be checked online at www.mhra.gov.uk. Usersmust exercise care, as this in itself is not a guarantee that theproduct is compliant or of an acceptably high quality.

If the device is sterile, has a measuring function, or falls into any ofthe other three classifications, the involvement of a Notified Bodyis mandatory in order to claim compliance with the Directive.

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Classes of Medical Devices

Class I Generally regarded as low riskClass IIa Generally regarded as medium riskClass IIb Generally regarded as medium riskClass III Generally regarded as high risk

Essential Requirements of CE Marking

Continued on page 10


NEW DEVICE

MARKET THE DEVICE

Determineclass using

Annex IXclassification

rules

Is thedevice sterile

or have a measuring function?

Ensure the device meets the ‘Essential Requirements’ in Annex

I which apply to it, taking into account its intended purpose

Maintain Post Market Surveillance, taking corrective action where required [vigilance] (To identify problems or risk, maintain safety of the product in the field and notify the Competent Authority of any serious adverse incidents)

NB involvement required to assess conformity with

metrological requirements and/or assess aspects of

manufacture concerned with securing and maintaining

sterile conditions

Class IIbClass IIaClass I

Annex VII: prepare technical documentation

Register device with the Competent

Authority (Form RG2)

Annex VII: prepare technical documentation

Annex III: prepare technical documentation &

submit with product to a NB for type examination

NB issue an EC typeexamination certificate

Increasing level of potential risk associated with the use of the medical device

Compile self declaration of conformity & apply

CE mark

Compile declaration of conformity & apply CE mark with NB registration number

NB issue certificate(s) of conformance for

the device

If sterile, also apply Annex V section 3 & 4 on aspects

of manufacturing that secure & maintain sterility

Annex IV examination & verification of every

device/batch by a NB

Annex V audit of production QA system by

a NB, to ISO 13485 (excluding design)

Annex VI audit of final inspection & testing QA system by a NB, to ISO

13485 (excluding design & manufacture)



OR

YES

NO

OR

OR

OR

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Class III

Annex III: prepare technical documentation plus supporting clinical evidence (as Annex X) & submit with product to a NB for type examination

NB issue an EC typeexamination certificate

Examination of design

dossier by a notified body

Annex II full quality assurance audit of design, manufacture and final inspection by a NB

to ISO 13485

Annex V audit of production QA system by

a NB, to ISO 13485 (excluding design)

Annex IV examination & verification of every

device/batch by a NB



NB issue certificateof conformance for

the device

NB issue certificate(s) of conformance for

the device



OR

OR

9

MedicalDevicesDirectiveConformity Assessment RoutesIt is illegal to sell a medical device that doesnot have a CE mark and meets therequirements of the Medical DevicesDirective. This diagram is a simplifiedinterpretation of the conformity assessmentroutes that a manufacturer must follow inorder to comply with the Directive.

Notes:

• NB = Notified Body

• Blue tinted boxes indicate that a NotifiedBody is directly involved in the process byeither the examination of technicaldocumentation and product, or an audit ofthe manufacturing facility

• This diagram is Robinson Healthcare’sinterpretation of information containedwithin the Medical Devices Directive. TheDirective should be consulted in order toclarify any aspect of this interpretation

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Understanding theMedical Devices Directive• Class I Sterile or Measuring Devices

Class l devices that are sterile or have a measuring functionrequire the least intervention by a Notified Body before they canbe placed on the market. Manufacturers of these devices musthave the aspect of metrology, or the process of manufacturingconcerned with securing and maintaining sterile conditionsaudited within the requirements of Annex lV, V or Vl of theDirective. If compliant, the Notified Body issues a certificate ofconformance, which allows the manufacturer to compile adeclaration of conformity and apply the CE mark to the product.The CE mark must also be accompanied by the Notified Body’sregistration number.

• Class IIa Devices

Class lla devices follow a similar route to Class l Sterile ormeasuring devices. Class lla devices are generally regarded asmedium risk and include products that are more invasive, such asRobinson Healthcare’s Instrapac® range of sterile, single usesurgical instruments. Following the preparation of technicaldocumentation under Annex Vll, a Notified Body must audit themanufacturer within the requirements of either Annex lV, V or Vl ofthe Directive.

• Annex lV – Verification by examination and testing to therelevant standards of every product, or a random sample fromeach production batch, to the requirements of the Directive andin conformity with the technical documentation.

• Annex V – Audit of Production Quality Assurance concerningassessment of the quality system and inspection of themanufacturing stage, including securing and maintaining sterileconditions, to relevant standards and the requirements of theDirective, in conformity with the technical documentation.

• Annex Vl – Audit of Production Quality Assurance concerningassessment of the quality system at final inspection and testingstage for every product or a random sample from eachproduction batch, to relevant standards and the requirements ofthe Directive, in conformity with the technical documentation.

Whichever route of conformance is selected, if the product issterile the Notified Body will also audit to sections 3 and 4 ofAnnex V. If compliant the Notified Body issues a certificate ofconformance, a declaration of conformity may be compiled andCE mark and registration number applied to the product.

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Routes to compliance (cont.)


The remaining two classes of device both require full NotifiedBody involvement in order to gain conformity to the Directive.Class llb devices are generally medium risk products that are morecomplex. For this reason, instead of the manufacturer preparingtechnical documentation under Annex Vll, it has to be submittedto a Notified Body along with samples of the device for typeexamination. This is covered by Annex lll and involves a fullassessment of the technical information and appropriate testing ofsample products. If they meet the requirements, an EC typeexamination certificate is issued. Assessment then continues aswith Class lla products.

Class lll are devices with the highest inherent risk. Productsinclude intra-uterine contraceptive devices and devices thatincorporate a substance that would be considered a medicinalproduct if placed on the market separately, such as RobinsonHealthcare Fast Aid® plasters with medicated wound pads. Theroute to conformance is similar to Class lla devices but again morerigorous. The Annex lll type examination must also include clinicalevidence derived from clinical trials to support the efficacy andsafety of the device. Following the issue of an EC typeexamination certificate, only the Annex lV and V options mayfollow, in order that the manufacturing process is audited before acertificate of conformance is issued.

Robinson Healthcare recommends that users request a copy ofmanufacturers certificates of conformance to confirm that they arecurrent and valid. BSI, Robinson Healthcare’s Notified Bodypublishes the status of manufacturer’s certification it has issued.This can be found online at www.bsigroup.com.

Alternative Route to ConformanceManufacturers may, if they choose, follow an alternative route toconformance for Class lla, Class llb and Class lll devices. Thisinvolves a full quality assurance audit as required by Annex ll ofthe Directive and covers the design, manufacture and finalinspection of the product concerned.

All aspects of the process of bringing the device to market areaudited. The Notified Body will also check products for conformity

at various stages of production, before issuing a certificate ofconformance. Additionally for Class lll devices, the full designdossier relating to each product type is examined to ensure itmeets the requirements.

Post-Market SurveillanceThe requirements of the Medical Devices Directive do not endwhen the device is successfully placed onto the market. TheDirective requires that all manufacturers implement an effectivepost-market surveillance system to ensure that quality problemsor risks associated with the use of the device are identified early,reported to the Competent Authority where necessary andcorrective or preventative action taken. Manufacturers are legallyobliged to maintain records of all adverse incident reports, toevaluate them promptly and take appropriate action. To facilitatethis the Directive also requires that manufacturers’ records permitfull traceability of all batches of any device. In addition to usercomplaints, manufacturers should also employ ongoing productreviews, user surveys, clinical follow-ups and other appropriatetests or reviews as part of the system.

If the adverse incident report indicates the device poses anunacceptable increase in risk, the manufacturer must report it tothe Competent Authority for investigation, evaluation andsubsequent action. This may involve a Field Safety CorrectiveAction (FSCA), a systematic recall of the device and a Field SafetyNotice (FSN) sent to all users that have purchased the product,with a warning and details of any action required. Users and thepublic can also report any problems directly to the CompetentAuthority for investigation.

Manufacturers are expected to do this on a voluntary basis. If not,the Competent Authority has powers to enforce the action andprosecute if appropriate, leading to fines or imprisonment in veryserious cases. All reported adverse incidents, FSCA’s and FSN’sare published online by the MHRA at www.mhra.gov.uk.

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• Class IIb and III Devices

Continued on page 12


Understanding theMedical Devices DirectiveThe term ‘medical device’ covers a wide range of productsinvolving many types and level of technology. The EssentialRequirements in Annex l can therefore only provide a broadapproach to reference standards. The Directive suggests thatmanufacturers adopt harmonised standards, but they may chosealternative methods of demonstrating compliance if they canshow that they are more appropriate, or if harmonised standardsdon’t exist.

Robinson Healthcare follow and, where appropriate are certified toharmonised standards. Where harmonised standards don’t exist,the most appropriate standard is used. For example, BritishStandards are followed for surgical instruments and the BritishPharmacopoeia, a collection of official standards for UK medicinalproducts, is used for absorbents and wound dressings. RobinsonHealthcare also holds certification to the following standards:

• BS EN ISO 9001:2008 – Quality Management System -A quality policy that covers all aspects of how the companydeals with customers, including customer service, productdevelopment, material procurement, manufacturing, traceability,testing, complaints, corrective action and customercommunication. It requires the demonstration of continualimprovement.

• BS EN ISO 13485:2003 – Medical Devices QualityManagement System - This incorporates medical deviceregulatory requirements within the quality system. Similar to ISO9001 but specific to medical devices as it includes controls toensure product safety, a focus on risk management, specificrequirements on inspection, traceability and the validation ofprocesses to produce sterile medical devices.

• Medical Devices Directive Annex V Certification – The mostcritical document demonstrating Product Quality Assurance,covering product manufacture. Without this a manufacturercannot legally affix a CE mark as it certifies that the facility andsystems meet the required standards necessary to secure andmaintain the sterility of a product.

• BS EN ISO 14644-1:1999 – Classification of the air cleanlinessin cleanrooms, based upon the concentration of airborneparticles. Certifies that the facility is a class 7 cleanroom asrequired for the manufacture of medical devices orpharmaceuticals.

• HTM2010 – Validation and verification that steam sterilisationfacilities meet the requirements of thermometric performance asset out in Health Technical Memorandum 2010 part 3. Anongoing record of the performance and result of every cyclemust be maintained.

Robinson Healthcare makes current certification available forexamination by customers at all times. Additionally, it invites andwelcomes customers to visit its manufacturing facility in Worksopto see first hand the laboratories, cleanroom, sterilisation facilityand production areas, to substantiate the company’s claim ofmanufacturing compliant, high quality products.

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Manufacturing and Product Standards & Certification

FM12010 MD514840


Environmental &Ethical Policy

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Environmental StandardsToday more than ever, a company’s environmental performance isa crucial issue as it affects staff, the local community and theinternational desire for a cleaner, greener future. In response,Robinson Healthcare invests heavily in environmentally friendlymanufacturing procedures and has certification to BS EN ISO14001:2004, the internationally recognised standard that definesthe establishment, implementation and operation of anEnvironmental Management System (EMS).

The EMS is a framework that allows Robinson Healthcare toconsistently control its impact on the environment, reduce the riskof releasing pollutants, ensure compliance with environmentallegislation and continually improve its business operations.Robinson Healthcare has made significant investment in a numberof areas:

• Efficient use of natural resources achieved by the installation ofa new high temperature steam generation plant and aircompressors

• Reduced impact on the local community through noisereduction initiatives

• Strict recycling policy, sending virtually zero waste to landfill

• Transfer of packaging materials to options that are whollyrecyclable or recycled

The company is fully committed to continual improvement in allareas, as required by ongoing certification toBS EN ISO14001:2004.

Organic AccreditationEnvironmental issues are high on the agenda of consumers as wellas businesses, with public concern growing for animal welfare andsustainable agriculture. This has seen a growing demand fororganic products and increased awareness of the environmentand social benefits of organic farming. Robinson Healthcare isfully supportive of this initiative and has certification for cottonwool products to The Soil Association standards. This uses theinternationally recognised Global Organic Textile Standards(GOTS) as its base.

The standard covers the processing, manufacturing, packaging,labelling and trading of organic natural fibres and includes:

• Severe restriction on the use of pesticides

• Prohibits the use of artificial fertilisers

• Bans genetically modified crops

• Social and fair employment criteria at all levels of the supplychain

• Audits of the processing, manufacturing and trading stages

Robinson Healthcare’s facility is audited for conformance by theSoil Association and includes verification of the organiccredentials of raw materials, management and segregation of thecotton wool to prevent contamination by non-organic materialsduring production and an examination of the company’s qualityand environmental certification.

Ethical PolicyRobinson Healthcare operates to high ethical standards. Todemonstrate this, the company is independently audited incompliance with the Ethical Trading Initiative (ETI) Base Code. Thisis a nine point, internationally recognised code of labour practice.The audit also encompasses raw material suppliers, requiringcompliance with the code in the context of local employmentlegislation. Robinson Healthcare personnel visit raw materialsuppliers every 6 months to carry out audits and ensure continuedcompliance with the code.

ETI Base Code

1. Employment is freely chosen2. Freedom of association and the right to

collective bargaining are respected3. Working conditions are safe and hygienic4. Child labour shall not be used5. Living wages are paid6. Working hours are not excessive7. No discrimination is practised8. Regular employment is provided9. No harsh or inhumane treatment is allowed

Robinson Healthcare is fully committed to meeting customers’ needs. This commitment also includesmuch wider responsibilities and embraces the need for high ethical and environmental standards thataffect customers and staff, whilst contributing to a sustainable future for everyone.

EM5555094TEXTILES RANGE


Customer Care & Service

Since 1839, Robinson Healthcare’s focus has been themanufacture of high quality healthcare products in the UK. Thesame is true today, with virtually all products produced at thecompany’s large manufacturing facility near Worksop inNottinghamshire.

Robinson Healthcare operates a ‘Deliver from Stock’ policy thanksto extensive stocks of finished goods, backed up by in-depthstocks of raw material. The company operates its own large Class7 cleanroom with hygienic manufacturing and packaging facilities,plus a twin chamber steam autoclave for product sterilisation. Thesite also has the UK’s only volume cotton wool manufacturingplant, converting raw material into finished product.

Control of the manufacturing process offers Robinson Healthcareflexibility to respond quickly as customer requirements change,unlike many other UK or overseas suppliers. Combining excellentstocks with this versatility ensures Robinson Healthcare maintainan enviable delivery performance, vital for healthcareprofessionals and retailers alike. When required, specific deliverytimes can be arranged to suit special requirements.

Customer Service and SupportField based specialist sales executives and the experiencedcustomer service team ensure orders are handled promptly,working closely with customers to coordinate allocation of stockand production capacity to ensure reliable deliveries. Theysupport customers in the UK and over 30 countries around theworld, managing standing orders, responding to stock and pricequeries or organising sample products for evaluation.

Robinson Healthcare deals directly with the NHS at all levelsincluding acute trusts, primary care trusts, GP’s and NHSconsortia. The field based specialists provide assistance withproduct training, clinical evaluations and trials, to help cliniciansand purchasing teams select the best solution and deliver valuefor money for the NHS.

Many Robinson Healthcare products are also available via NHSSupply Chain or are listed on the Drug Tariff, ensuring productsare readily available whichever procurement channel is preferred.Robinson Healthcare has also formed close partnerships withcarefully selected Medical Distributors that support the RobinsonHealthcare brand. These distributors break bulk, offering anadditional service for customers who are unable, or prefer not topurchase full cases due to limited storage or low usage.

Retail customers include pharmacy distributors, high streetretailers and major grocery retail multiples. Robinson Healthcarealso manufactures own brand products for a number of householdname retailers, offering a bespoke service that delivers highquality products, a reliable and uninterrupted supply and value formoney.

Investing for the Future - E-CommerceMethods of customer trading have changed many times since thecompany was founded in 1839. Today, a large number ofcustomers have already adopted electronic trading with RobinsonHealthcare as a way of streamlining purchasing and invoicing. Tomeet the next challenge, Robinson Healthcare has committedsignificant investment in e-commerce to develop new services tosupport existing and new business via online trading to all marketsectors.

Services include:

• Streamlined order processing, incurring virtually zerotransactional costs

• 24 Hour online ordering via account or electronic payment

• Live stock enquiries and allocation

• Trading history and regular order baskets

• Call off of standing orders

• Live order tracking

This investment will ensure that Robinson Healthcare retains itsmarket leading position in the manufacture of professional andpersonal healthcare for many years to come.

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Robinson Healthcare fully understands that a consistent and reliable supply of quality products is criticalfor customers, whether in healthcare services or fast-paced retail operations. Robinson Healthcare’s wellestablished reputation for world class customer service is underpinned by two key elements – a UKbased manufacturing facility and a high quality, dedicated workforce.

Flexible Logistical Strength


Checklist For All Products• Is the supplier manufacturing the products in the UK to maintain control of quality and supply?

• Are you able to visit the manufacturing facility to assess the supplier’s capabilities and the quality of the manufacturingprocesses?

• Can the supplier demonstrate a track record of manufacturing quality products and offer for you to speak to existingcustomers for their opinion?

• Does the supplier have significant stocks of finished goods to ensure an uninterrupted supply of products?

• Does the supplier have significant stocks of raw material as a contingency against supply delays, to ensure continuedproduction of finished goods?

• Is the supplier certified to BS EN ISO 9001:2008 – Quality Management System?

• Is the supplier certified to BS EN ISO 14001:2004 – Environmental Management System?

• Are you able to verify the certification by copy of the certificate and checking the status with the issuing body?

• Is the manufacturing facility operated in accordance with Good Manufacturing Practice (GMP)?

• Is the supplier independently audited to a recognised Ethical Employment and Trading Standard?

Checklist For Medical Devices• Do all medical devices carry a CE mark in compliance with the Medical Devices Directive 93/42 EEC?

• Does the supplier hold certificates of conformity assessment for the required Annexes of the MDD?

• For sterile products, does the supplier hold Annex V Production Quality Assurance certification?

• Does the supplier use an authorised Notified Body for certification?

• Are you able to verify the certification by copy of the certificate and checking the status with the Notified Body?

• Can the supplier demonstrate that products are manufactured in accordance with British, European or ISO standards asappropriate, or alternatively the British or European Pharmacopoeia?

• Are all products checked, packaged and, if appropriate sterilised in the UK to maintain control of quality and supply?

• Does the supplier have a cleanroom validated and operated to BS EN ISO 14644-1:1999 for the hygienic manufacturing orpackaging of sterile products?

• Are products sterilised on site and, if so, is the facility validated and operated to HTM2010

• Is the supplier certified to BS EN ISO 13485:2003 – Medical Devices Quality Management System?

• Can the supplier demonstrate that they operate a post market surveillance system?

Checklist For Consumer Products• Is the supplier certified to the British Retail Consortium (BRC) Global Standard for Consumer Products?

• Can compliance with the Cosmetics Directive 76/768/EC be demonstrated for skin cleansing products?

• Does the supplier have certification to the Soil Association Textile Standard for any products claimed as organic?

• Do first aid products that are captured by the Medical Devices Directive (sterile or medicated plasters, bandages anddressings) comply with the Directive, carry the CE mark and have the appropriate certificates of conformity assessment issuedby a Notified Body?

Useful Contact Details• A full list of all European Notified Bodies – www.ec.europa.eu/health/medical-devices

• Notified Bodies designated by the MHRA – www.mhra.gov.uk/Howweregulate/Devices/NotifiedBodies

• Medical Devices Alerts - www.mhra.gov.uk/Safetyinformation

• MHRA Medical Devices register - www.mhra.gov.uk/Howweregulate/Devices/Registrationofmedicaldevices

• BSI Client Directory of Certification - www.bsigroup.com/en/Assessment-and-certification-services

• BRC Directory of Certification - www.brcglobalstandards.com

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Customer Checklist

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With so many suppliers of professional and personal healthcare products, choosing the right one canoften be a minefield for users and procurement teams. How can you be sure that the products are fit forpurpose, will perform effectively, comply with appropriate regulations, will be available when required andwill represent value for money? To help, Robinson Healthcare suggests this handy checklist to remindcustomers of what to look for and ask of potential suppliers. Robinson Healthcare meets every item onthe checklist.

Key:A = Robinson Healthcare

B = Other potential supplier


Frequently AskedQuestions

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What is a medical device?

Any instrument, apparatus, appliance, material or other article,whether used alone or in combination, including the softwarenecessary for its proper application intended by the manufacturerto be used for human beings for the purpose of:

• diagnosis, prevention, monitoring, treatment or alleviation ofdisease,

• diagnosis, monitoring, treatment, alleviation of or compensationfor an injury or handicap,

• investigation, replacement or modification of the anatomy or ofa physiological process,

• control of conception,which does not achieve its principal intended action in or on thehuman body by pharmacological, immunological or metabolicmeans, but may be assisted in its function by such means.

What is the Medical Devices Directive (MDD)?

This is European legislation, enacted in UK law by the MedicalDevices Regulations that harmonise national controls. It regulatesthe safety and marketing of medical devices throughout theEuropean Union and places legal obligations on manufacturers toensure that their devices are safe and fit for their intendedpurpose.

Why is the MDD needed?

It is designed to ensure that all devices within the EU are safe inuse, identified by the application of a CE mark. It specifies“essential requirements’ which must be met before a device canbe placed on the market; introduces controls covering safety,performance, specification, design, manufacture and packaging ofdevices; and specifies requirements for assessment of clinicalinvestigations and evaluation of any adverse incidents.

What is the difference between the MDD & The Medicines Act?

The Medicines Act 1968 is UK legislation concerning medicinalproducts rather than medical devices. Medicine is defined as anysubstance presented as having properties for treating orpreventing disease in human beings, or exerts a pharmacological,immunological or metabolic action. The Act requires thatmedicines be licensed before being allowed onto the UK market. Itis UK legislation, not European. Products have to be licensedseparately in each country. The MDD is European legislation anddevices that comply may be freely traded anywhere in the EU.

What is a Competent Authority (CA) and what does it do?

This the regulatory body within a member state (country) of the EUthat is charged with ensuring that a Directive is correctlyimplemented. For medical devices in the UK, the CA is theSecretary of State for Health acting through the Medicines &Healthcare products Regulatory Agency (MHRA). They designateNotified Bodies and oversee the services they perform.

What is a Notified Body and what does it do?

This is an independent certification organisation that is qualified toperform conformity assessment procedures for manufacturers ofmedical devices and certify compliance with the MDD. They areassessed and designated by the Competent Authority of thecountry in which they are based. A manufacturer can choose touse any Notified Body designated by any Competent Authority inthe EU carry out the assessments, not necessarily one in their owncountry.

What is the difference between BS, EN and ISO standards?

These are national, European and international standardsrespectively, setting specifications that promote best practice. BS,or British Standards, are standards formulated on a national levelin the UK. The National Standards Body for the UK is the BritishStandards Institution (BSI). BSI is also, quite separately, a NotifiedBody designated by the MHRA. EN standards are EuropeanStandards, formulated collectively by the National StandardsBodies of 30 EU nations. Many EN standards are now harmonisedwith national standards. ISO standards are international,developed collectively by 162 nations (BSI represents the UK).Some standards are harmonised at all levels, e.g. BS EN ISO 9001

What is the difference between ISO 9001 and ISO 13485?

Both are harmonised Quality Management Systems (QMS), butISO 13485 has been developed specifically for the manufacture ofmedical devices. It is based on the ISO 9001 format but withadditional product specific requirements concerning design, riskmanagement, validation of sterilisation, environmental control,traceability and regulatory actions. It excludes some of therequirements of ISO 9001 not appropriate in a regulatedenvironment - customer satisfaction (considered subjective) andcontinual improvement.

What is Annex V certification?

This refers to a conformity assessment to Annex V of the MedicalDevices Directive, one of the routes to compliance for Class lSterile or Measuring, Class lla and llb and Class lll devices. Itdemonstrates Production Quality Assurance of the manufacturingprocess and contains specific requirements to secure andmaintain the sterility of a product and for devices with a measuringfunction.

What does Post Market Surveillance involve?

This is a requirement for manufacturers under the MDD and is themonitoring and control of risk associated with the use of thedevice. Procedures to collect the data include customercomplaints and concerns, customer surveys, product reviews,control of non-conforming products, focus groups and producttests and evaluations. Data has to be analysed and anyunacceptable increases in risk have to be reported to the MHRAfor evaluation and action. This may involve a Field SafetyCorrective Action (FSCA), a systematic recall of the device and aField Safety Notice (FSN) sent to all users that have purchased theproduct, with a warning and details of any action required.

Is there a register of all Medical Devices?

Not currently, though one is proposed. The MHRA website has adirectory of all UK companies that have registered that they supplyClass l medical devices, custom made devices, systems andprocedure packs, as required by the MDD (see page 15 for URL)


© Copyright 2011 Robinson Healthcare Ltd.All rights reserved. No part of this publication may be reproduced, stored in a retrieval system, or transmitted in any form or by any means, electronic, mechanical photocopying,recording or otherwise without the prior permission of Robinson Healthcare Ltd.

Every care has been taken in compiling this brochure. However, in the view of the possibility of typing, printing or other errors, the reader should not rely solely on the informationcontained herein.

Publication Ref: RHC01/11/1KSeptember 2011

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eProduct RangeRobinson Healthcare manufactures a diverse range of products for the professional, personal andanimal healthcare markets. Listed below is an overview of the products available. For full details,please contact Robinson Healthcare.

Single Use Instruments• Surgical Packs • Women’s Health • ENT • Forceps • Scissors • Supplementary Items • Podiatry • Dental

Absorbents• Gamgee® • Cotton Wool • Gauze Swabs • Maternity Pads • Dental Absorbents

Wipes• Dry Wipes • Skin Cleansing Wipe • Surface Wipes

Woundcare• Dressings • Multi-Layer Bandage System • Bandages • Adhesive Dressings

Patient Identification

First Aid• Plasters (Fast Aid®) • Dressings • Tapes & Bandages • Kits • Plasters (Patch & Go®)

Cotton Wool• Soft & Pure® • Cottontails®

Personal Care• Heat Pads • Earplugs • Fresh Ups Moist Wipes • Supplementary Items • Breast Pads • Disposal Bags

Continence Care• Bed Pads • Seat Pads & Bibs • Bedding Protectors • Disposable Bed Pads • Pants & Briefs

Animal Care• Animalintex® Dressings • Veterinary Gamgee® • Woundcare & Bandages • Veterinary Supplementary Items


Robinson Healthcare LtdLawn RoadCarlton-in-LindrickWorksopS81 9LBTel: +44 (0)1909 735000Fax: +44 (0)1909 735040Email: [email protected]: www.robinsonhealthcare.com


Documents

Manufacturers of Professional, Personal & Animal …assessments, Robinson Healthcare also uses BSI to independently certify compliance with a number of other very important standards