3 days under the MDR & new MDCG Position Paper on UDI

26 of May 2021 was probably the most important day of 2021 for the medical device community in terms of regulatory changes. The Medical Device Regulation (MDR) has repealed the Medical Device Directive (MDD) and is now applicable throughout the Union market for the third day in a row.

Only manufacturers of certain types of devices (so called ”legacy devices”) can still benefit from the grace period and place their devices on the EU market in a ”hybrid” regime, i.e. where on top of complying with the MDD, they also need to respect certain requirements of the MDR, such as vigilance, post-market surveillance, registration of actors & devices, having a PRRC, MDR EAR (for non-EU manufacturers, excluding for ex. Turkish manufacturers!). Moreover, also Articles 10-15 of the MDR related to economic operators apply from 26 May 2021.

All other devices (excluded from the ”legacy device” definition, mainly those without a valid CE Certificate and being a simple Class I device) shall fully comply with the MDR before being placed on the Union territory. Recently, the European Commission released a helpful Factsheet addressing specifically Class I medical device manufacturers. You can find this and all other relevant documents issued by the European Commission in our dedicated Library-European Commission.

Furthermore, the MDR date of application has had a significant impact on the Swiss manufacturers as well as companies selling in Switzerland. Especially, in view of the fact that Switzerland decided not to continue talks with the EU on the Institutional Agreement, which has an impact on the Mutual Recognition Agreement (MRA).

As of 26 May 2021, Swiss manufacturers are considered as any other non-eu manufacturer and will need to, among others, appoint an EAR – European Authorised Representative. On the other hand, there is a transitional period to appoint a Swiss Representative for any non-Swiss based company wishing to sell their devices in Switzerland, as reported on MDlaw on 19 May 2021.

MDR date of application has arrived, however, we still expect many Guidance documents from the MDCG, Common Specifications and other implementing acts in the coming months! MDlaw will keep you updated with all the latest regulatory updates concerning EU MDR through our News and Library of Documents section! If you are not yet a member, check for membership options here!

In this line, we would like to inform you of the new MDCG Position Paper on the Implementation of UDI requirements for contact lenses, spectacle frames, spectacle lenses & ready readers. In this document, the MDCG recalls MDR requirements related to UDI assignment, placing UDI on the label, registration to UDI module of EUDAMED and related timelines. It also presents the set-up for these special devices:

a) for contact lenses, a specific UDI assignment solution is under development by the MDCG UDI WG, which may also be extended to spectacle frames;

(b) for spectacle lenses and ready readers, whilst a specific UDI assignment solution is agreed (MDCG 2020-18) its practical application is yet to be formalised;

UDI Assignment: the above mentioned products are expected to be in compliance with the UDI assignment obligations set out in Art 27(3) and Art 29 (1) MDR, applying mandatorily from 26 May 2021, until specific UDI assignment solutions are finalised.

UDI Carrier Labelling: for Implantable devices and Class III devices, Class IIa/IIbdevices and Class I devices, UDI labelling requirements apply from May 2021, May 2023, and May 2025 respectively. As the majority of the aforementioned products are Class IIa/IIb devices and Class I devices, it is expected that there will be sufficient time to reflect the specific UDI assignment solutions on the label.

UDI & Device Registration: registration of devices starts to apply 24 months after the date of publication of the notice referred to in Article 34(3) MDR. Before this time, or until specific UDI assignment solutions are finalised, manufacturers of the abovementioned products are instructed not to use on a voluntary basis, the UDI/Device registration module of EUDAMED, to register devices and UDI related information as established in Part A and B of Annex VI MDR.

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