Preparing for new

regulations

23rd October 2014

Nicola Hickie,

Medical Devices Assessor

Responsibilities of economic operators

Crowne Plaza Hotel, Northwood, Santry.

EU Commission

proposal for a

regulation of the

European Parliament

and of the Council

on medical devices

(542/2012)/

... on in vitro

diagnostic medical

devices (541/2012)

23/10/2014 2

ST 5458/14:

http://register.consilium.europa.eu/content/out?lang=EN&

typ=ENTRY&i=SMPL&DOC_ID=ST-5458-2014-INIT

Challenge

• Obligations of Economic Operators

(Chapter II)

• Information required to build

transparency, identification and

traceability (Chapter III)

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• Transparency

• Build Confidence

Focus

Part I

Roles & Responsibilities of Economic Operators

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Clarification of obligations

• Manufacturer responsibility – clear set of requirements

• Demonstrate conformity – technical documentation

and EU Declaration of Conformity (Annexes II and III)

• General safety and performance requirements (Annex I)

- CTS

• Requirements on clinical evaluation/evidence and post-

market [clinical] follow-up (Annex XIII - medical

devices/ Annex XII IVDs)

• At least one person responsible for regulatory

compliance (RP)

• Provision of essential information to patients

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Manufacturer – article 8

• The natural or legal person who manufactures or fully refurbishes a device or has a device designed, manufactured or fully refurbished, and markets that device under his name or trademark.

• Regulatory requirements proportional to risk

• Document and implement a QMS that minimises non-conformance (Article 8 para 6).

• Technical Documentation and DoC required to demonstrate compliance with legal requirements – keep for 10 years1.

• DoC to accompany device

1CWP discussions have suggested a change from 5 – 10 years. And 15 years for implantable devices.

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• Comply with the obligations related to the UDI system (article 24)

• Comply with EO and device registration requirements (article 25)

• Implement a post market surveillance plan

• Include a plan for post market clinical follow up – Annex XIII part B

• Report on post market surveillance2

• Labelling and IFU (Annex I)

• Non-conforming device – inform stakeholders

• Cooperate with competent authority requests 2Distinction between post market surveillance (MFR) and market

surveillance (CA)

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Authorised Representative (AR) – article 9

• Manufacturer outside of the EU – designate an AR within the EU

• Accept role in writing

• Written mandate agreed

• AR provides copy of mandate to importer & CA on request

• AR terminates mandate – inform the competent authority

• Have a person responsible for regulatory compliance (RP) at their disposal

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Authorised Representative - mandate

• Copy of technical documentation, DoC, NB certificate

• Comply with registration obligations (article 25)

• Provide the CA with information & documentation demonstrating conformity

• Cooperate with the CA on any corrective actions to eliminate risks

• Immediately inform manufacturer of complaints

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Importers – article 11

• Any natural or legal person established within the Union who

places a device from a third country on the Union market;

• Verify that an AR has been designated and notified of the

devices the importer is placing on the market

• EU DoC / CE marked/ Labelling and IFU

• UDI assigned by the manufacturer

• Inform stakeholders of non-conformities/risks – full

engagement of manufacturer

• Verify that device is registered on electronic system (article

25) – add importer details

• Name and address of registered business

• Register of complaints

• Cooperate with authorities and inform relevant stakeholders 23/10/2014 10

Distributors – article 12

• Any natural or legal person in the supply chain, other than the manufacturer or the importer, who makes a device available on the market;

• Only make available devices in conformity with regulation

• Verify CE/ DoC/ IFU provided

• UDI verification

• Importer/ manufacturer registration requirements met

• Inform manufacturer and AR where device is non-conforming or presents a risk

• Storage & transport conditions are met

• Cooperate with Competent Authority and manufacturer

• Register complaints and forward to manufacturer

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Person responsible for Regulatory Compliance –

article 13

• Manufacturers shall have permanently at their disposal a ‘responsible person’

• Expert knowledge in Medical Devices field

• Conformity is appropriately checked in accordance with the quality system

• TD and DoC drawn up

• Post market surveillance obligations

• Information on risks associated with devices is collected and evaluated and measures coordinated

• Reporting obligations are fulfilled

• AR shall have at least one RP who possesses expert knowledge on regulatory requirements for devices in the Union

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Parallel trade – article 14

• Clear conditions set for EOs involved in re-labelling or packaging of devices

• Obligations of manufacturer carry over to EO’s, when:

– make available on the market a device under his name, registered trade name or registered trade mark;

– change the intended purpose of a device already on the market;

– modify a device already on the market in such a way that compliance with the applicable requirements may be affected

Parallel importer requirements

• Indicate the activity carried out, his name and address on the device

• Ensure a QMS in place ensuring translation of information is accurate and up-to-date

• Activities preserve original condition of device

• Packaging is not defective or of poor quality

• QMS to include procedures ensuring the distributor/ importer is informed of Corrective actions in response to safety issues

• Prior to making devices available – inform the manufacturer and CA – sample of relabelled device

• Submit a NB certificate attesting that the QMS complies with requirements

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Part II

Transparency, traceability and identification

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Chapter III

Identification & traceability

• EO’s must have oversight of the supply chain

• manufacturers to fit their device with a UDI

Registration of devices & EO’s

• manufacturers, authorised representatives and importers - register on a central European database

SSCP data

• Obligation to make the summary of safety and performance data publicly available for high risk devices

Further development of European databank

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Unique Device Identification

Chapter III Article 24 MDR/ Article 23 IVDR

• Requirements of the UDI System:

• Production of UDI (DI + PI)

• Placement of UDI on label of device

• Establishment of electronic system on UDI

• Storage of the UDI through electronic means

• Comm to designate a number of entities that operate a system for assignment

• Mfr shall assign a UDI before placing a device on the market

• EO’s shall store and keep by electronic means the DI and PI of their devices

• The Commission, in cooperation with the Member States, shall set up and manage an electronic system on UDI to collate and process the information.

• Accessible to the public.

• UDI shall be used for reporting serious incidents and field safety corrective actions

Slide 17

UDI No.

DI:

PI:

UDI No.

DI:

PI:

UDI No.

DI:

PI:

To:

To: To:

From: From:

European UDI Database:

UDI No; DI data only

Mfr Distr Hosp

Registration of devices & EOs (Art 23 IVDR/ Art

25 MDR)

• ALL devices registered on central EU database

• Visibility of the supply chain

• Annex V, Part A

• Manufacturer/ Importer/ Authorised Rep

• UDI device identifier

• NB certificate details

• Accessible to the public

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Summary of safety and [clinical] performance

(Art 26 MDR/ Art 24 IVDR)

• Class III implantable and devices emitting ionising radiation – drawn up by MFR

• Class C and D IVDs

• Clear to intended user and patient

• Available to public via Eudamed

• Summary data provided with the device

– Intended purpose

– Description of accessories

– Limitations of device

– Clinical performance

– Clinical evidence

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EUDAMED (Data stored in the European MD databank)

Electronic

System

on

Certificates

Electronic

System

on

Vigilance

Electronic

System

on

Clinical

Investigations

&

Clinical

Performance

Studies

Electronic

System

on

market

surveillance

Information on

measures taken

by MS in case of:

Non-compliant devices

presenting a risk to

health and safety;

Compliant products

presenting a risk

to health and safety;

Formal non-compliance

of devices;

Preventive health

protection measures.

Electronic

System

on

Unique

Device

Identification

(UDI)

Information on:

DI data elements

Electronic

System

on

Registration

Information

on

devices

and

Economic

operators.

EUDAMED (Data stored in the future European MD databank art 27 (MDR)/ Art 25 (IVDR))

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Challenges & Opportunities

Opportunities Challenges

Increased traceability Practical aspects to be defined –

national registers/ DoC/ AR

mandate

Increased transparency EO’s roles – appropriately defined?

Increased access to information Importer/ Distributor versus AR/

RP obligations

Clarification on roles and

responsibilities

Registers – Eudamed/ Complaints

and how they interface

Decrease in diverging national

requirements

Decrease in administrative costs

(long term)

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Final thoughts...

• Good progress w.r.t. clarifying weaknesses

of current Directives

• Positive impact on patient safety

• Clarification required on practicalities

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