EU Medical Device Regulation
European Union Medical Device Regulations
EU – Medical Device Regulations
Responsibilities of Authorised representative
• When a device manufacturer is established outside of the European Union, the manufacturer needs to appoint an authorised representative to place the medical device in one of the member states. An Authorized Representative is any person naturally or legally established in the European Community who can act on behalf of the manufacturer.
• A written mandate/letter designating an authorised representative for a medical device manufacturer is mandatory. The authorised representative must provide a copy of the mandate to the competent authority when requested.
Role of Authorised Representative
Registration in EUDAMED
1. Eudamed is the European Databank on Medical Devices. It’s a secure, web-based portal developed by the European Commission to implement Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnostic medical devices.
2. The system is a collection of databases and electronic systems. It will function as a registration system, a collaborative system, a notification system, and a dissemination system (open to the public) and will be interoperable.
3. Register at here: https://webgate.ec.europa.eu/eudamed/landing-page#/
4. EUDAMED is structured around six interconnected electronic systems and a public website:
a) Actors registration (Economic Operators)
b) UDI/Devices registration
c) Notified Bodies and Certificates
d) Clinical Investigations and performance studies
e) Vigilance and post-market surveillance
f) Market Surveillance
Purpose of EUDAMED
Information in EUDAMED
a) On registration of manufacturers, authorised representatives, and devices
b) Declaration of conformity
c) Justification of the classification according to Annex IX
d) A copy of ISO certificate/Proof of QMS
e) Relating to certificates issued, modified, supplemented, suspended, withdrawn, or refused
f) Obtained in accordance with the Medical Device Vigilance System
g) Information of clinical investigations
Timeline for registration
➢ The declared will of the co-legislator to grant an 18-month additional transitional period for device registration and registration of certificates,
➢ The logical correspondence and complementary character of device data elements in Part A (Section 2) and Part B of Annex VI,
➢ The need to ensure that information on devices in EUDAMED is not displayed to public in a partial or misleading nature.
Registration Data Sets – MDR
Registration Data Sets – MDR (system/procedure pack)
How we assist you with this process?