EU – Authorised Representative
Responsibilities of EU 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 EU Authorised Representative
- Verify that the EU declaration of conformity and technical documentation has been drawn up and, where applicable, that an appropriate conformity assessment procedure has been carried out by the manufacturer.
- Keep available a copy of the technical documentation, the EU declaration of conformity and, if applicable, a copy of the relevant certificate, including any amendments and supplements, at the disposal of competent authorities for the period.
- Comply with the registration obligations and verify that the manufacturer has complied with the registration obligations.
- In response to a request from a competent authority, provide that competent authority with all the information and documentation necessary to demonstrate the conformity of a device, in an official Union language determined by the Member State concerned.
- Forward to the manufacturer any request by a competent authority of the Member State in which the authorised representative has its registered place of business for samples, or access to a device and verify that the competent authority receives the samples or is given access to the device.
- Cooperate with the competent authorities on any preventive or corrective action taken to eliminate or, if that is not possible, mitigate the risks posed by devices.
- Immediately inform the manufacturer about complaints and reports from healthcare professionals, patients and users about suspected incidents related to a device for which they have been designated.
- Terminate the mandate if the manufacturer acts contrary to its obligations under this Regulation.
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 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
- To enable the public to be adequately informed about devices placed on the market, the corresponding certificates are issued by notified bodies and the relevant economic operators.
- To enable unique identification of devices within the internal market and to facilitate their traceability.
- To enable the public to be adequately informed about clinical investigations and to enable sponsors of clinical investigations to comply with obligations under articles 62 to 80, article 82, and any acts adopted pursuant to Article 81.
- To enable manufacturers to comply with the information obligations laid down in articles 87 to 90 or in any acts adopted pursuant to Article 91.
- To enable the competent authorities of the member states and the commission to carry out their tasks relating to this regulation on a well-informed basis and to enhance the cooperation between them.
Information in EUDAMED
- Depending on the applicable directive, Eudamed2 contains data
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 the 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 on clinical investigations
Timeline for registration
- “With regard to timelines for device registration, the text of the MDR presents an inconsistency. On the one hand, Article 123(3)(d) lists the full Article 29 as being applicable from the application dates or, if EUDAMED is not functional on time, six months after the date of publication of the notice referred to in Article 34(3). On the other hand, Article 123(3)(e) grants an additional 18-month transitional period for obligations contained in Article 29(4).
- Taking into account:
➢ 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.
- The obligation for registration in EUDAMED of device data elements listed in both part A, Section 2, and Part B of Annex VI, shall be applicable as from the timelines indicated in Article 123(3)(e) (meaning from 18 months after the general application date or, if EUDAMED is not fully functional on time, from 24 months after the date of publication of the notice referred to in Article 34(3)).
Registration Data Sets – MDR
Registration Data Sets – MDR (system/procedure pack)
How we assist you with this process?
- EU MDR, IVDR gap analysis
- EU MDR, IVDR compliance
- EUDAMED registration
- Act as your EU Authorised Representative
- Help to be in compliance with EU local registrations like Portugal, France, Italy, Germany etc.,
- Document translations in all EU languages.
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