MEDICAL DEVICES Regulatory Affairs Directorate Technical Regulations Division November 2018

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

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

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

respectively • During transition period: devices can fall under current EU Directives

or 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)

MDR Transition timelines Article 120 of Regulation (EU) 2017/745

IVDR Transition timelines Article 110 of Regulation (EU) 2017/746

CE marking • CE marking varies according to risk class for MDs and IVDs –

other 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)

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)

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

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).

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).

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

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 obligations under the Regulation and is not located in the EU

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)

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 on the market and inform authorities

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

Roles and Responsibilities of Distributors

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

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

obligations and devices bear UDI

• Distributors shall ensure proper storage and transport conditions are in line with manufacturer recommendations

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 operators about complaints and incidents and keep a register of non-conformities

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

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

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

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”