Medical Devices

EU MDR – EUDAMED registration deadline clarified

The Adents Team Written by The Adents Team
12-Jun-2019

Regulation EU 2017/745 or the European Medical Devices Regulation (EU MDR) was officially adopted in April 2017. Among requirements set out by the EU MDR are Unique Device Identification (UDI), intensive premarket testing and post market surveillance and increased transparency through the setting up of a European database on medical devices called EUDAMED.

The database shall include information on devices, economic operators, clinical research and post-market surveillance. EUDAMED will help regulatory authorities coordinate and exchange information and will also be used to report and track incidents. Manufacturers of medical devices will have to register.

EUDAMED Medical Device registration deadline

Given inconsistencies regarding the deadlines for registering medical devices in the EUDAMED database, the Medical Device Coordination Group (MDCG) has issued a communication clarifying this issue and establishing November 26, 2021 as the deadline for obligatory registration of medical devices of all classes. Should EUDAMED not be functional by November 26, 2021, an additional transition period of 6 months will apply. This has no impact on any other deadlines, in particular regarding marking requirements for the different classes of devices.

Voluntary vs. obligatory EUDAMED registration

Voluntary registration will be possible from May 2020, presuming that EUDAMED is operational. However, in case of an incident, full registration as per art. 29 of the MDR is required. This is a precondition for uploading the incident report into EUDAMED.

Who is the Medical Device Coordination Group (MDCG)?

The MDCG comprises representatives of all Member States and it is chaired by a representative of the European Commission. Established through article 103 of the EU MDR, it provides advice to the Commission and assists both, the Commission and Member States, to ensure a harmonized implementation of the European Medical Devices Regulations 2017/745 and 2017/746.

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The Adents Team
The Adents Team

The Adents Team: your serialization experts. With over 25 years of experience in different fields of product traceability, supply chain, big data and pharmaceutical serialization, our team members bring a wealth of knowledge to help you better understand the challenges and opportunities of serialization.

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