MEDICAL DEVICES Regulatory Affairs Directorate Technical Regulations - - PowerPoint PPT Presentation

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MEDICAL DEVICES Regulatory Affairs Directorate Technical Regulations - - PowerPoint PPT Presentation

Dec 09, 2022 4.77k likes •5.12k views

MEDICAL DEVICES Regulatory Affairs Directorate Technical Regulations Division November 2018 Overview Introduction Timelines CE marking Unique Device Identifier (UDI), Transparency and Traceability Eudamed Database

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MEDICAL DEVICES

Regulatory Affairs Directorate Technical Regulations Division November 2018

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Overview

  • Introduction
  • Timelines
  • CE marking
  • Unique Device Identifier (UDI), Transparency and Traceability
  • Eudamed Database
  • Roles and Responsibilities of Economic Operators:
  • Authorised Representatives (ARs)
  • Importers
  • Distributors
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Introduction

Medical Devices Regulation (2017/745/EU) (MDR) and In-Vitro Diagnostic Medical Devices Regulation (2017/746/EU) (IVDR):

  • 1. In line with technical advances, changes in medical science, and

progress in law making

  • 2. Create a robust, transparent and sustainable regulatory framework,

recognised internationally, that improves clinical safety and creates fair market access to manufacturers

  • 3. Compared to Directives, Regulations do not need transposition into

national law therefore reduce risks of discrepancies in interpretation across the EU market

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Timeline

  • MDR and IVDR: 3 year (2020) and 5 year (2022) transition period

respectively

  • During transition period: devices can fall under current EU Directives
  • r the new MDRs
  • Designation process for NBs: ≥12 months for each designation

taking a significant part of the transition period

  • Limited time for manufacturers to get all products re-certified under

new regulations. An extended period after date of application of regulation for re-certification for most devices to avoid disruption and unavailability

  • After transition period: devices must comply with MDR & IVDR (unless

they wish to make use of the extended period of CE certificate validity)

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MDR Transition timelines

Article 120 of Regulation (EU) 2017/745

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IVDR Transition timelines

Article 110 of Regulation (EU) 2017/746

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CE marking

  • CE marking varies according to risk class for MDs and IVDs –
  • ther factors including sterile for MDs or self tests for IVDs may

influence the conformity assessment procedure

  • MDs – all Class IIa, IIb and III and some specific Class I need

intervention of NBs

  • IVDs – Class A devices can be self-certified by manufacturers

unless sold sterile. Class B, C and D require conformity assessment by NB. (85% of IVDs need oversite of NB compared to 20% under directive)

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UDI, Transparency and Traceability

  • New feature: Unique Device Identifiers (UDIs) enhance

identification, traceability and allow stakeholders to access information through Eudamed

  • UDI composed of 2 parts: device identifier (UDI-DI) specific to

each device and a production identifier (UDI-PI) (ex: lot number, serial number)

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Eudamed Database

  • information on UDI, registration of economic operators and

devices, certificates, clinical/performance investigations, post- market surveillance, vigilance and market surveillance

  • Basic information on devices and check if devices are covered

by an appropriate certificate

  • Report incidents and used as a platform for authorities to

cooperate and exchange information

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Roles and Responsibilities

Example cases where other economic operators (importers, distributors and others) assume the obligations of a manufacturer:

  • When an economic operator makes the device available on the

market under its name or trade name

  • Intended purpose is changed or when the device is modified in

such a way it affects its compliance with the regulations MDR describes device modifications that are considered as not affecting compliance (Article 16 para 2).

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Roles and Responsibilities of ARs

‘Authorised Representative’ means any natural or legal person established within the Union who has received and accepted a written mandate from a manufacturer, located outside the Union, to act on the manufacturer’s behalf in relation to specified tasks with regards to the latter’s obligations under this regulation

  • Many Responsibilities of ARs in Article 11 MDR (and IVDR).
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Roles and Responsibilities of ARs

  • ARs have to verify that all regulatory documentation and

information demonstrate the compliance of the device including: technical documentation, DOC and certificates

  • ARs have to verify that the manufacturer has registered the

requested information Eudamed

  • ARs may terminate a mandate should the legal manufacturer act

contrary to the requirements of the Regulations and inform the national CA

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Roles and Responsibilities of ARs

  • ARs have to cooperate with authorities on preventive and

corrective actions and inform legal manufacturer immediately about complaints

  • ARs will be liable for defective devices together with the

manufacturer, if the manufacturer has not complied with

  • bligations under the Regulation and is not located in the EU
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Roles and Responsibilities of Importers

‘Importer’ means any natural or legal person established within the Union that places a device from a third country on the Union Market

  • Responsibilities of Importers in Article 13 MDR (and IVDR)
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Roles and Responsibilities of Importers

  • Importers should make sure the devices are compliant including:

CE marking, required information, labelling and UDI

  • Importers should make sure devices are registered on Eudamed
  • If a non compliance is encountered by importers, should not place
  • n the market and inform authorities
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Roles and Responsibilities of Importers

  • Importers should inform manufacturers and ARs in the event of
  • complaints. They should keep registers of complains and non-

conformity and escalate non-compliance to authorities

  • Importers should make sure storage and transport conditions do

not jeopardise compliance

  • Importers should cooperate with the authorities and provide

samples or grant access to the devices

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Roles and Responsibilities of Distributors

‘Distributor’ means any natural or legal person in the supply chain,

  • ther than the manufacturer or the importer, that makes a device

available on the market, up until the point of putting into service

  • Responsibilities of Distributors in Article 14 MDR (and IVDR)
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Roles and Responsibilities of Distributors

  • Distributors should verify devices have CE mark and

accompanied with regulatory information and documentation.

  • Distributors should verify that importer has complied with all
  • bligations and devices bear UDI
  • Distributors shall ensure proper storage and transport conditions

are in line with manufacturer recommendations

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Roles and Responsibilities of Distributors

  • If distributor encounters a non-compliance, the device should not be

made available on the market. Distributor should inform other economic operators and authorities in case device is falsified or if there is a serious risk health

  • Distributors should inform manufacturers and other economic
  • perators about complaints and incidents and keep a register of non-

conformities

  • Distributors should cooperate with authorities and other economic
  • perators on corrective actions and make available all the

documentation

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Useful Links

  • MDR: https://eur-lex.europa.eu/legal-

content/EN/TXT/?uri=CELEX:32017R0745

  • IVDR: https://eur-lex.europa.eu/legal-

content/EN/TXT/?uri=CELEX:32017R0746

  • Regulatory Framework European Commission:

https://ec.europa.eu/growth/sectors/medical-devices/regulatory- framework_en

  • Factsheet for Authorised Representatives, Importers and distributors of

Medical Devices: http://www.mzcr.cz/Soubor.ashx?souborID=34573&typ=application/pdf &nazev=MD_REP-IMPORT-DISTRIB_Factsheet.pdf

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Useful Links

  • Implementation model: medical devices:

https://ec.europa.eu/docsroom/documents/30905

  • Exhaustive list: requirements for medical devices manufacturers:

https://ec.europa.eu/docsroom/documents/30961

  • Factsheet for manufacturers of in-vitro diagnostic medical devices:

http://ec.europa.eu/docsroom/documents/30907

  • Factsheet for manufacturers of medical devices:

https://ec.europa.eu/docsroom/documents/31201

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THANK YOU!

Sarah Farrugia sarah.c.farrugia@mccaa.org.mt 23952227

“Whilst every effort has been made to ensure the accuracy of the information supplied herein, the Technical Regulations Division within the Malta Competition and Consumer Affairs Authority states that further issues related to lack of compliance with the applicable directives and/or regulations may be present and which may have not been identified” “While every effort has been made to ensure the accuracy of the information supplied herein, the Technical Regulations Division within the Malta Competition and Consumer Affairs Authority cannot be held responsible for the information quoted herein and/or for any errors or omissions of the information supplied”