FASTER KNOW THE WAY · 6 ©SGS Belgium NV: Vlaamse dag van de CE markering: Medical Devices 16 June 8 th 2016 Classification rules “Intended use”: • NOT the particular technical

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CE Marking of Medical Devices

Bart Mersseman

Head of Notified Body SGS BelgiumThursday Octobere 12th 2017

Vlaamse dag van de CE-markering

2©SGS Belgium NV: Vlaamse dag van de CE markering: Medical Devices

June 8th 2016

CE Marking for Medical devices

Prologue: Legislation in Europe and

some definitions

GET YOUR MEDICAL DEVICES TO MARKET

FASTER WHEN YOU KNOW THE WAY


June 8th 2016

Current legislation in Europe

Until 2012: slow evolution• AIMDD: Directive 90/385/EEC covering active

implantable medical devices

• MDD: Directive 93/42/EEC covering medical devices

• IVDD: Directive 98/79/EC covering in vitro diagnostic medical devices

• Directive 2000/70/EC covering medical devices incorporating stable derivates of human blood or human plasma

• Directive 2003/12/EC on the reclassification of breast implants

• Directive 2003/32/EC covering medical devices utilizing tissues of animal origin

• All directives are transposed into Belgian law (idem in the Netherlands)

• 21 March 2010: Directive 2007/47/EC: these amendment of MDD 93/42/EEC came into force

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June 8th 2016

Recent changes in Europe

Since 2012 (after PIP Breast implant scandal) : revolution ?

� New European regulations/directives:

• COMMISSION RECOMMENDATION of 24 September 2013

– on the audits and assessments performed by notified bodies in the field of medical devices (2013/473/EU)

– Was ‘immediately’ applicable (25 September 2013)

– Major changes and major consequences: significant changes

e.g. unannounced visits


June 8th 2016

Recent changes in Europe

What will the future bring us:

� 25 May 2016 !: EU agreed new Regulations on

• medical devices and

• in vitro diagnostic medical devices

• Still to be voted in the European Parliament, but the text is decided

– making sure that medical devices and in vitro diagnostic medical devices are safe

– while allowing patients to benefit of innovative health care solutions in a timely manner.

– by strengthening the rules on placing devices on the market and

– tightening surveillance once they are available.


June 8th 2016

Basic definitions

medical device

Medical accessories

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June 8th 2016

Definitions: Medical Device

What is a Medical Device – Medisch Hulpmiddel – Dispositif Médical?

� According to Medical Device Directive (MDD) articel1

• instrument, apparatus, appliance, software, material or other article

• used in human beings

• intended by the manufacturer to be used (intended use –

beoogde gebruik - utilisation prévue)

• diagnosis, prevention, monitoring, treatment or alleviation of disease

– thermometer, arterial stent, heating patch (rheuma), radiology device

• diagnosis, monitoring, treatment, alleviation or compensation for an injury or

handicap

– Plaster , wound care gel, wheel chair, hearing aid, glasses, lenses

• investigation, replacement or modification of the anatomy or of a physiological

process

– Breast implant, artificial kidney (dialysis), knee implant, teeth implant

• control of conception,

– condoom , intra uterine device (IUD)


June 8th 2016

• Is this a medical device?

Time for a little exercise


June 8th 2016

Definitions: Medical Device

What is a Medical Device – Medisch Hulpmiddel – Dispositif Médical?

� Excluded from the MDD: principal intended action in or on the human body

• pharmacological : pharmaceutical product, even in combination with a MD

– Nicotine plaster, plaster with hormones

• immunological : even in combination with a MD

– Vaccination syringe, allergy tests (on patient)

• metabolic : even in combination with a MD

– Insulin syringe

� Also excluded from MDD, but are medical devices:

• In vitro diagnostic devices=>Directive IVDD:

– medical blood analyzers, POCT devices

• Active implantable devices=>Directive AIMDD

– Pacemaker, ear implant

� Borderlines: breast pump, electronic cigarette, syringe, …

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June 8th 2016

Definitions: Medical Accessory

What is an Accessory – Hulpstuk – Accessoire?

� not being a (medical) device

� specifically intended to be used together with a device

� classified in their own right separately from the device with which they are used

� Accessories shall be treated as medical devices in their own right (for the purposes of the MDD)

� Examples:

• Spectacle-case

• Gel for ultrasonography

• Mount piece for spirometer


June 8th 2016

Definitions: CE marking

When is CE marking required?

� All medical devices and accessories if:

• Class I (low risk) and not sterile nor a measuring function: CE without number of a Notified Body

– Wheel chair, normal hospital bed, …

• All other: CE with number (and certificate) of a Notified Body

– Measuring spoon for medication (e.g. couch syrop),

physiotherapy device, sterile dressing, wound contact gel, …

• Except….


June 8th 2016

Definitions: CE marking

When is no CE marking allowed?

� No CE marking allowed

• Custom-made device:

• Systems and procedure packs (containing only devices bearing the CE

Marking)

• Devices intended for clinical investigation (pre-market):

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June 8th 2016

Classification (annex IX)

principles

definitions

Classification rules


June 8th 2016

Classification: principles

� Classification:

• the most rigorous conformity assessment procedure for all medical devices ?

• graduated system of control is more appropriate

• apply an appropriate conformity assessment procedure.

�Risk based system

• Vulnerability: a ‘risk based’ system based on the vulnerability of the human body

• intended purpose: Each device is evaluated based on the

intended purpose (see technical documentation, but also labelling or ‘IFU’)


June 8th 2016


� There are 4 classes identified (risk for patient/user):

• Class I devices: Low risk devices

– Class I sterile

– Class I measuring function

• Class IIa devices: Medium low risk devices

• Class IIb devices: Medium high risk devices

• Class III devices: High risk devices

“We had never an incident with our arterial stent, so this is not a high risk device “

“Yes, it is just a bed, very low risk. The heating blanket is to keep the patient somewhat warm after surgery.”

???

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June 8th 2016


� “Intended use”:

• NOT the particular technical characteristics of the

device

• NOT the accidental use of the device

• NOT the class assigned to other similar products

“Our competitor placed the “CE” mark without number of a Notified Body, so this is clearly classified as class I

device.”


June 8th 2016

Classification rules: criteria/features

� Criteria/features:

• Active: electrical energy or any source of power

• Invasiveness: body orifice, surgical invasive, implantable

• Duration of contact: transient, short term, long term, continuous use (uninterrupted use)

� But also:

• Reusable instrument

• Therapeutical use

• Diagnostical use

• Local or systemic use (anatomical location)

– central circulatory system

– central nervous system


June 8th 2016


� There are 18 rules in 4 groups:

• 4 non invasive devices (rules 1 to 4)

• 4 invasive devices (rules 5 to 8)

• 4 active devices (rules 9 to 12)

• 6 special rules (rules 13 to 18)

� consideration all the rules in order to establish the proper classification for its device..

� More than 1 rule applicable: highest classification is applicable: e.g. wound dressing containing silver

� Details on the device classifications can be found in the MEDDEV guideline 2.4/1 Rev. 9 June 2010

http://ec.europa.eu/health/medical-devices/documents/guidelines/

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June 8th 2016

Classification rules (see also MedDevMEDDEV 2. 4/1 Rev. 9)


June 8th 2016

The certification process

1. Contact with Notified Bodies

2. Conformity assessment procedure

3. Technical documentation

4. Medical quality system (role of EN ISO 13485)


June 8th 2016


Part 1: Contact with Notified Bodies



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June 8th 2016

CE-Marking: Notified Body

1 As early as possible: check applicable directives and standards, check

definitions

2 During development stage: contact your Notified Body

3 During development stage: start compiling technical documentation

4 Write your quality (system) manual (procedures, work instructions,

registration forms)

5 Implement your quality system and finish technical documentation

6 Review of the technical documentation and certification audit by your

Notified Body

7 Affix CE marking

8 Periodically (at least once a year) surveillance audits by your Notified

Body

9 Unannounced audits

10 Post market surveillance/clinical follow up


June 8th 2016


What is a Notified Body?

� A private organisation, operating in a competitive market

� Notified by the European Commission.

� Monitored by a member state: Competent Authority e.g.

• Belgium: FAGG / AFMPS / FAMHP (Federal Agency for Medicines and Health Products)

� New: Joint Assessments of medical devices Notified Bodies by Member States and Commission Experts

Role of a Notified Body

� Provide services for conformity assessment on the conditions set out in the directives in support of CE marking

� Normally: assessing the manufacturers conformity to the essential requirements listed in each directive.• Inspection• Quality assurance• Type examination• Design examination• Combination of above

Notified Body


June 8th 2016

EU Commission

Competent Authority Sweden

Competent Authority Belgium –

F.A.G.G./A.F.M.P.S.

Competent Authority UK - MHRA

Notified Bodies Sweden

Notified Bodies UK

SGS United Kingdom Ltd

Notified Body 0120

Notified Bodies Belgium

SGS Belgium NV

Notified Body 1639

Manufacturer UK Manufacturer Overseas

Authorised Representative

Etc.Etc.

Etc.

Etc.


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June 8th 2016


Part 2: Conformity assessment procedure




June 8th 2016

CE-Marking: Conformity assessment procedure

Conformity assessment procedure:

1 It is the choice of the manufacturer

2 Possible choices depends from the classification of the medical device

3 The choice has an impact on the quality system and the certification

4 Different routes: historically due to national different approach on how to assess

the safety and effectiveness of medical devices

5 Described in the Medical Device Directive and in different guidance documents

e.g.


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June 8th 2016


Part 3: Technical documentation




June 8th 2016

CE-Marking: technical documentation

Specified in MDD 93/42/EEC

• annex VII

• annex II

One of the aims: to prove that the device is in conformity with the essential

requirements of the MDD (see annex 1 of the MDD)

Described in document NB MED 2.5.1(rev.5): Technical Documentation

For class I, IIa, IIb en III

Also applicable document GHTF/SG1/N011:2008: Summary Technical

Documentation (STED)

Extent of the technical documentation depends on:

• Classification, complexity, …

• Use of innovative technology, product, …

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June 8th 2016


Possible structure

1 Device description and product specification

2 ‘Labelling’ (or ‘draft labelling’)

3 Design and Manufacturing Information

4 Essential Requirements Checklist

5 Risk management file

6 Verification and validation of the device

7 Required declarations (or proof if such a declaration is not

possible)

8 Declaration of Conformity

:


June 8th 2016


1 Device description and product specification

a. Device description:

� Intended use/purpose

e.g.

This medical disinfectants is intended for chemically disinfecting of non-invasive medical devices. It

is used during the washing process of surgical drapes.

� Intended patient population and medical condition

� Principles of operation of the device;

� Classification (and motivation)

e.g.

The sterile infusion cannulae are surgically invasive

The cannulae are intended for short-term use (more than 60 minutes, but less than 30 days).

The cannulae are not in direct contact with the heart, central circulatory or central nervous system

The Cannulae are chemical inert in the body, don’t have biological effect and don’t supply energy

=> Annex IX, rule 7, class IIa

� Chosen annex of MDD 93/42/EEC for the conformity assessment procedure (annex II, VII+V, …)

� Accessories

� Variants


June 8th 2016


1 Device description and product specification (continuation)

b. Product specification as in brochures and other information made available to the end

user, including

� Features

� performance attributes

� If applicable: dimensions

� Variants and accessories

c. Reference to the manufacturer’s previous generation(s) of the device, if such exist, or (if

relevant) similar devices available on the market.

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2 ‘Labelling’ (or ‘draft labelling’)

a. Labels put on the device and packaging

b. Instructions for use, technical manual, ...

c. Promotional / commercial material


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3 Design and Manufacturing Information

a. Design of the device (e.g. flowchart for class I, IIa en IIb)

b. Production processes (e.g. Flowchart with reference to procedures, workinstructions,....)

c. Design- and production sites and how they are controlled (+ ISO certificates)

=> this is a equivalent to Device Master Record (cookbook)


June 8th 2016


4 Essential Requirements Checklist (MDD annex 1: can be downloaded f.e.Eucomed):

Take care: all amendments of 2007/47/EC

Take care: is also machinery of personal protective equipment directive applicable?

a. Well motivated 1 Critical (pre)clinical evaluation

2 Relevant harmonised standards

3 Tests, Studies, publications, research,…: Biocompatibility studies, Laboratory tests, Simulated use tests …

4 (critical) comparison with existing (comparable) devices: published literature regarding the device or substantially similar devices.

b. Don’t forget to motivate all essential requirement deemed NOT applicable even it seems streight

forward.

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June 8th 2016


5 Risk management file

a. ISO14971:2007: this is a whole process

b. Multidisciplinary team

c. Not only risk analysis, but also risk control measures and reducing the risk to an

acceptable level.


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6 Verification and validation of the device

a. All studies, all tests, all data, all publications a.o. that are used to prove that the device meets the essential requirements. Test reports of harmonised standards are necessary (if relevant)

b. Biocompatibility

c. Medicinal substances

d. Biological safety of devices incorporating animal or human cells, tissues or their derivatives:


June 8th 2016


e. Sterility

1. Bioburden tests

2. Pyrogenity tests

3. Testing for sterilant residues (if applicable)

4. Packaging validation

f. Software verification and validation (Harmonised standard ISO 62304:2006)

g. Pre-clinical evaluation

h. Clinical evaluation

1. Obligatory for class IIa, IIb and III medical devices

2. Can be based on clinical trials/studies, but is not obligatory, except for class III medical devices

3. Can be based on critical literature study

4. Bibliography alone is deemed insufficient as clinical evaluation !

5. Following Directieve annex X en MEDDEV. 2.7.1 latest revision

i. ‘Life time’ or ‘shelf life’ of the medical device

Rapport of aging tests

Motivated expected lifetime

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June 8th 2016


7 Required declarations (or proof if such a declaration is not possible):

a. Device doesn’t contain animal tissue

b. Device doesn’t contain phthalates

c. Device doesn’t contain human cells, blood, tissues or their derivatives;

d. Device doesn’t contain pharmacological components

8 Declaration of Conformity

a. During initial assessment by a Notified Body: only Draft version possible

b. On official company paper (containing logo a.o.)

c. Classification

d. Chosen conformity route (chosen annex of the MDD)

e. Used harmonised technical standards

f. Trade name (if different), product name, product code and/or other unambiguous

reference of the device(s)

g. Reference to the CE certificate, …

h. Signed by qualified person and dated


June 8th 2016

CE-Marking: technical documentation: DoC

EC DECLARATION OF CONFORMITYWe,

(Name + address of the (authorised representative of the) manufacturer)

hereby declare under our sole responsibility that the CE marked product(s)

to which this declaration relates,

(trade name if different, product name, product code and/or other

unambiguous reference of the Device(s))

(has)(have) been classified as Class ………, according to Annex IX, rule …,

and (are)(is) in conformity with the essential requirements and provisions of the

Council Directive 93/42/EEC concerning medical devices

…


June 8th 2016


Part 4: Medical quality system –

ISO 13485:2003



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June 8th 2016

CE-Marking: Medical quality system

Technical documentation

+

Quality system

Quality (management) system: harmonised standard EN ISO13485:2012 !

1. Quality manual + procedures/work instructions/documents/...

2. How are critical subcontractors controlled

3. Risk management procedure

4. Procedures for all regulatory requirements:

a. Vigilance procedure (incidents or near incidents)

b. Classification,

c. Clinical evaluation,

d. Unannounced audits, ...

e. Translation procedure (if applicable)

f. Post market surveillance procedure

g. Post-market clinical follow-up procedure

h. ...


June 8th 2016

CE-Marking: Medical quality system

� EN ISO13485:2012 :

• the promotion and awareness of regulatory requirements as a management responsibility.

• controls in the work environment to ensure product safety

• focus on risk management activities and design transfer

activities during product development

• specific requirements for inspection and traceability for

implantable devices

• specific requirements for documentation and validation of processes for sterile medical devices

• specific requirements for verification of the effectiveness of corrective and preventive actions

� EN ISO13485:2016: is now publicised, but not yet

harmonised (March 2016)


June 8th 2016

CE-Marking: audit cycle: certification

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June 8th 2016

CE-Marking: audit cycle: surveillance visits

1. At least once a year surveillance visits according to MDD (and harmonised standards EN

ISO13485:2012)

2. Unannounced audits

3. Important in the quality system:

� Regulatory and statutory documents containing also harmonised standards and official guidance

documents e.g. MedDev documents

� Post-market clinical follow-up e.g.

� Complaints, client feed-back, but also clinical feed-back

� Unexpected/adverse effects

� New publications, new technologies, …

� Post market surveillance and Vigilance (Fields Safety Actions or Notices)

� Control of subcontractors e.g. validity of quality management certificates (ISO13485:2003, GMP …)

� Notifications of relevant changes to the quality system and/of device

4. Important in the technical file:

� Changes that didn’t required immediate reassessment

� Risk management file: this is living document

� Clinical evaluation: this is a living document

� State-of-the-art

� Full (re)assessment possible


June 8th 2016

information sources (ordered by relevance)

1 National transposition of the European Directives

http://www.fagg-afmps.be/en/human_use/health_products/medical_devices_accessories/

2 European Directives:

http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CONSLEG:1993L0042:20071011:EN:PDF

3 MedDev documents (publicised by the European Commission: de facto obligatory)

http://ec.europa.eu/health/medical-devices/documents/guidelines/index_en.htm

4 Harmonised standards (name of standards publicised by the European Commission: de facto obligatory)

http://ec.europa.eu/enterprise/policies/european-standards/harmonised-standards/medical-devices/index_en.htm

5 NB Med documents (publicised by the Notified Bodies Medical Devices)

http://www.team-nb.org/index.php?option=com_docman&task=cat_view&gid=17&Itemid=38&lang=en

6 IMDRF (International Medical Device Regulators Forum) and GHTF

http://www.imdrf.org/

7 Notified Bodies en Competent Authorities

SGS: http://www.medicaldevices.sgs.com/index.htm

MHRA: http://www.mhra.gov.uk/Publications/Regulatoryguidance/Devices/index.htm


June 8th 2016

New Medical Device Regulations (MDR)

• 5 May 2017: Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 78/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC

=> also called: MDR

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June 8th 2016

New Medical Device Regulations (MDR): MDR chapters

I. Scope and definitions

II. Making available on the market and putting into service of devices,

obligations of economic operators, reprocessing, CE marking, free movement.

III. Identification and traceability of devices and of economic operators, summary of safety and clinical performance, European database on

medical devices.

IV. Notified bodies

V. Classification and conformity assessment

VI. Clinical evaluation and clinical investigations

VII. Post-market surveillance, vigilance and market surveillance

VIII. Cooperation between Member States, medic device Coordination Group, expert laboratories, expert panels and device register.

IX. Confidentiality, data protection, funding and penalties

X. final provisions .


June 8th 2016

New Medical Device Regulations (MDR): MDR Annexes

I. General Safety and Performance Requirements

II. Technical Documentation

III. Technical Documentation on Post-Market Surveillance

IV. EU Declaration of Conformity

V. CE Marking of Conformity

VI. A. Information to be submitted upon registration of devices and Economic Operators in accordance

with Articles 29(4) and 31,

B. Core data elements to be provided to the UDI Database together with the UDI-DI [UDI device

identifier] in accordance with Articles 28 and 29

C. the UDI System

VII. Requirements to be met by Notified Bodies

VIII.Classification Rules

IX. Conformity assessment based on a Quality Management system and on

assessment of Technical Documentation

X. Conformity assessment based Type-Examination


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XI. Conformity assessment based on Product Conformity Verification

XII. Certificates issued by a Notified Body

XIII.Procedure for Custom-Made Devices

XIV.Clinical Evaluation and Post-Market Clinical Follow-Up

XV. Clinical Investigations

XVI.List of groups of products without an intended medical purpose referred to

in Article (2)

XVII.Correlation Table

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June 8th 2016

New Medical Device Regulations (MDR): some focus

1. Software as Medical Device

2. Claims

3. Authorised Representative

4. Supply Chain / Economic operators

5. Person responsible for regulatory compliance

6. OBL: Cases in which obligations of manufacturers apply to importers, distributors or other persons

7. Identification and traceability

8. Upgrade of the Clinical Evaluation and Clinical Investigation

9. National Implementation

10.Entry into force, application, transition provisions...


June 8th 2016

MDR: Software as Medical Device

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Rule 11

� Software intended to provide information which is used to take decisions with diagnosis or therapeutic purposes is classified as class IIa, except if

such decisions have an impact that may cause:

• death or an irreversible deterioration of a person's state of health, in which case it is in class III; or

• a serious deterioration of a person's state of health or a surgical intervention, in which case it is classified as class IIb.

� Software intended to monitor physiological processes is classified as

class IIa, except if it is intended for monitoring of vital physiological

parameters, where the nature of variations of those parameters is such that it could result in immediate danger to the patient, in which case it is

classified as class IIb.

� All other software is classified as class I.


June 8th 2016


Rule 11

� Software intended to provide information which is used to take decisions with diagnosis or therapeutic purposes is classified as class IIa, except if

such decisions have an impact that may cause:

• death or an irreversible deterioration of a person's state of health, in which case it is in class III; or

• a serious deterioration of a person's state of health or a surgical intervention, in which case it is classified as class IIb.

� Software intended to monitor physiological processes is classified as

class IIa, except if it is intended for monitoring of vital physiological

parameters, where the nature of variations of those parameters is such that it could result in immediate danger to the patient, in which case it is

classified as class IIb.

� All other software is classified as class I.

Not just decisions made by the software itself, but also decisions made by doctors and patients, hardware or other software medical devices.

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2. Claims










June 8th 2016

MDR: Claims

Article 7: Claims

In the labelling, instructions for use, making available, putting into service and advertising of devices, it shall be prohibited to use text, names,

trademarks, pictures and figurative or other signs that may mislead the

user or the patient with regard to the device's intended purpose, safety and performance by:

a) ascribing functions and properties to the device which the device does not

have;

b) creating a false impression regarding treatment or diagnosis, functions or

properties which the device does not have;

c) failing to inform the user or the patient of a likely risk associated with the use

of the device in line with its intended purpose;

d) suggesting uses for the device other than those stated to form part of the intended purpose for which the conformity assessment was carried out.


June 8th 2016

MDR: Claims

Article 7: Claims

Don’t forget to inform all likely risks (including contra-indications and side-effects)

• Indications– Consistent in theTechnical Documentation, in all labelling, in advertising, ...

– All claims shall be proven in the clincial evaluation file

– Shall be described in the IFU

• Contra-indications – Consistent in theTechnical Documentation

– Are described in the risk management file

– Are the outcome of the clincial evaluation file


• Side-effects– Consistent in theTechnical Documentation

– Are described in the risk management file

– Are the outcome of the clincial evaluation file


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2. Claims










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MDR: Authorised Representative

• Article 11: if the legal manufacturer is not in a Member State:– …a sole authorised representative...and same for generic device group

– …mandate…accepted in writing by the authorised representative

– … the authorised representative shall be legally liable for defective devices on the same basis as, and jointly and severally with, the manufacturer….

– …authorised representative... terminate the mandate if the manufacturer acts contrary to its obligations under this Regulation and shall immediately inform the competent authority of the Member State …and…the notified body

• Article 12: change of Authorised Representative– detailed arrangements for a change of authorised representative shall be clearly

defined in an agreement between the manufacturer, where practicable the outgoing authorised representative, and the incoming authorised representative


June 8th 2016



2. Claims









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MDR: Supply Chain

• Explicit obligations imposed on importers (art. 13) and

distributors (art. 14) (check your contracts !)…


June 8th 2016



2. Claims










June 8th 2016

MDR: Own Brand Labelling/Manufacturing (OBL/OBM)

Cases in which obligations of manufacturers apply to importers, distributors or other persons (art 16)

� A distributor, importer or other natural or legal person shall assume the

obligations incumbent on manufacturers if it does any of the following:

a) makes available on the market a device under its name, registered trade name or registered trade mark, except in cases where a distributor or

importer enters into an agreement with a manufacturer whereby the manufacturer is identified as such on the label and is responsible for meeting

the requirements placed on manufacturers in this Regulation;

b) changes the intended purpose of a device already placed on the market or

put into service;

c) modifies a device already placed on the market or put into service in such a

way that compliance with the applicable requirements may be affected.

=> OBL (Own Brand Labelling/Manufacturing) doesn’t exists anymore !

…

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2. Claims










June 8th 2016

MDR: Person responsible for regulatory compliance

Person responsible for regulatory compliance (art. 15)

� Manufacturers (and authorised representatives) shall have available

within their organisation at least one person responsible for regulatory compliance who possesses the requisite expertise in the field of medical

devices. …

• requisite expertise is described in art. 15

� Except: companies < 50 Employees and < 10 Mio Revenue shall not be

required to have the person responsible for regulatory compliance within their organisation but shall have such person permanently and

continuously at their disposal


June 8th 2016

MDR: Person responsible for regulatory compliance

Person responsible for regulatory compliance (art. 15)

� The person responsible for regulatory compliance shall at least be

responsible for ensuring that:

a) the conformity of the devices is appropriately checked, in accordance with the quality management system under which the devices are manufactured, before a device is released;

b) the technical documentation and the EU declaration of conformity are drawn up and kept up-to-date;

c) the post-market surveillance obligations are complied with in accordance with

Article 10(10);

d) the reporting obligations referred to in Articles 87 to 91 are fulfilled;

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2. Claims










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MDR: Identification and traceability

� Unique Device Identification system (‘UDI system’) (art. 27)

1. a UDI device identifier (‘UDI-DI’) specific to a manufacturer and a device,

2. a UDI production identifier (‘UDI-PI’) that identifies the unit of device

production and if applicable the packaged devices

=> Aim: facilitate identification and traceability e.g. UDI shall be used for reporting serious incidents and field safety corrective actions

� the manufacturer shall assign to the device a UDI created in compliance with the rules

� placing of the UDI on the label of the device or on its packaging;

� UDI-DI of the device shall appear on the EU declaration of conformity

� storage of the UDI by economic operators, health institutions and

healthcare professionals

� electronic system for Unique Device Identification (‘UDI database’).


June 8th 2016

UDI: a system covering 3 elements

1. UDI-code

Unique Device Identification – CODE

� DI: Device ID:

unique numeric or alphanumeric code specific to a manufacturer and a device model

� PI: Product Identifier:

lot/batch no., serial no., expiry [use by] date, date of manufacture [in any combination]

2. AIDC

Automatic Identification and Data Capture

3. UDID: UDI database: DI is ‘key’ in this

database

UDI

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June 8th 2016

MDR: Identification and traceability

� Electronic system for registration of economic operators (art. 30 and 31)

1. single registration number to identify the manufacturer and, where applicable, the authorised representative and the importer

2. national provisions on registration of distributors of devices


June 8th 2016

UDI: interaction between UDI and Eudamed


June 8th 2016



2. Claims









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New MDR: CER


June 8th 2016

New MDR: CER


June 8th 2016

New MDR: CER

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June 8th 2016

New MDR: CER

� Periodic Safety Report:


June 8th 2016

New MDR: CER

� Class III and implantable devices: SSCP

� Made available to public via Eudamed


June 8th 2016

New MDR: CER

28


June 8th 2016



2. Claims










June 8th 2016

MDR: National Implementation

However: (supplementary) national regulation still expected/possible

For example:

� Reusability of Single Use Devices

� Registration of distributors

� Some aspects concerning Clinical Investigations:

• E.g. compensation and insurance system

� fines and penalties

� taxes and fees for carrying out market surveillance


June 8th 2016



2. Claims









29


June 8th 2016

MDR: Entry into force, application, transition provisions...


June 8th 2016


Documents

FASTER KNOW THE WAY · 6 ©SGS Belgium NV: Vlaamse dag van de CE markering: Medical Devices 16 June 8 th 2016 Classification rules “Intended use”: • NOT the particular technical