Our February MedTech news round up covers the EU Commission’s new information on the management of legacy devices and IVDs, an update on the EU and Switzerland’s MRA, some useful FAQ’s on EUDAMED’s Actor Module registration, plus updates from China on UDI submission and Egypt on IVD reagent registration. Read on to find out more.
EU commission publishes processes for management of legacy devices and IVDs
The European Commission has published new information regarding how legacy medical devices and IVDs will be managed in Europe’s EUDAMED database.
The term “legacy device” covers any medical device or IVD with a valid CE Mark certification under existing European Medical Device Directives, that may remain on the European Union market after the MDR and IVDR application dates, for as long as their existing CE Marking remains valid.
Additional processes have been laid out for EUDAMED registration for these products, including Unique Device Identification (UDI)-related requirements and considerations. The new information builds on the April 2019 guidance regarding EUDAMED registration for legacy devices. Click here for details of how legacy devices will be identified in EUDAMED and how different Unique Device Identifiers for these devices will be generated/assigned.
EU and Switzerland MRA / IFA: Avoiding distortion of trade in medical devices
The EU and Switzerland currently rely on a Mutual Recognition Agreement (MRA) for trade in medical devices. The MRA does not however cover most of the requirements of the Medical Device Regulation (MDR).
Unless updated, this MRA will in effect cease to function as a means of trade facilitation on 26 May 2021.
Whilst the EU and Switzerland are currently negotiating an update to the Institutional Framework Agreement (IFA), until the negotiations are concluded, it seems unlikely that the MRA on medical devices trade will be updated.
As such, the MedTech industry cannot assume that an updated MRA between the EU and Switzerland on medical devices will be in place in time for the MDR application date, resulting in Switzerland becoming a third country for the purposes of the implementation of the MDR. Download this document from MedTech Europe for more information.
Useful FAQ’s for Actor Module registration in EUDAMED
In November last year we reported how the European Commission was making the Actor Registration Module available to Member States and economic operators from 1 December 2020.
Since then, the EU Commission has published a useful FAQ’s document which covers information regarding the countries available in EUDAMED, the Actor registration process, single registration numbers (SRN), Actor roles, EUDAMED users, support and data exchange. Access the document here.
China’s UDI Submission now in effect
As of 1 January 2021, China’s UDI system for the submission of the first group of devices took effect.
For the medical devices listed in the “First Group of Unique Device Identification Devices” list, applicants applying for initial registration, registration renewal or change of registration are required to submit the unique identifier of unique device identification (UDI-DI) information in the registration management system according to the template provided on the website.
For more information click here.
Egypt soon to require registration of IVD reagents
The Egyptian Drug Authority (EDA) will begin requiring registration for IVD reagents, with implementation of this new requirement starting this year.
As of 1 April 2021, the requirement to obtain an import permit from the EDA for importation of IVD reagents will be strictly enforced.
Local Egyptian manufacturers will be required to submit their registration file to the EDA by 1 July 2021. By 1 January 2022, manufacturers of imported IVD reagents classified as List A or List B will need to have obtained a marketing license from the EDA. And by 1 January 2023 manufacturers of imported IVD reagents classified as General/Other or Self-Testing will need to have obtained a marketing license from the EDA.
For more information, click here (link in Arabic).
That concludes our February MedTech news. Check back in March for more.
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