MDCG Addition to “IVDR to-do List”, official publication of this MDCG news announcement from April 1, 2022.
The Medical Device Coordination Group is responsible for fundamental issues in the medical device industry. The issues range from Notified Body monitoring and standardization to market surveillance. Related international problems, innovative technology, and clinical research are also within the range of their focus. Its expertise originates from its division into 13 subgroups, which respectively provide advice and draft guidance on their expertise field.
The members of the subgroups are appointed by the Member States for a duration of 3 years. Stakeholders participate as observers and are appointed following a call for applications procedure also for a duration of 3 years. They meet regularly with the EU Commission as Chair. It is the MDCG addition to the IVDR to-do list and Eudamed that we discuss in this article.
Why Is the Section on Older Devices Updated?
There is a need for guidelines on what will happen in May 2022. Therefore, the MDCG has amended its joint implementation and preparedness plan for the In Vitro Diagnostic Regulation (IVDR). This includes sections on older devices and Eudamed.
The EU is implementing IVDR in stages. It means that more tests will become legacy devices than were initially envisaged. Legacy devices are goods that were put on the market under the previous directive. The IVDR mentions legacy device regulation, but MDCG believes the “wording of this paragraph is rather general.” This necessitates a clarification of the particular regulations that would apply to older devices beginning in May 2022.
MDCG has added fresh guidance to its list of priority activities in this regard. The goal is to cover the application of IVDR requirements to legacy devices in the same way that MDCG covered the Medical Device Regulation (MDR). This guidance is still in the consultation stage. However, it is expected to be released in the second quarter of 2022, according to MDCG.
Why Is the Section on Eudamed Updated?
In addition to the update of the section on Older Devices, a new paragraph on Eudamed has been included. Because the Eudamed database will not be completely functional until May 2022, IVDR will not make use of the system mandatory or enforceable. “Guidance on harmonized administrative practices and alternative technical solutions for the exchange of information until Eudamed becomes fully functional,” MDCG concluded.
What Is the Objective of these Updates?
Member states and other stakeholders will be able to “meet their obligations under the IVDR effectively while minimizing any potential additional burden on the parties concerned.” The committee is primarily concerned with “cases where the exchange of information would be difficult, or even impossible, to achieve in absence of guidance.” With this in mind, the advice is in the consultation stage and has a second-quarter timeframe.
New priority actions on advice for notified bodies, performance evaluation, and expert panels have been included in the amended IVDR. The second and third quarter timeframes are being worked on for the two texts.
MDCG Addition to IVDR to-do List: sources, links & downloads:
- MDCG Update
- Nick Paul Taylor from RAPS
- Medical Devices Directive – 93/42/EEC
- Active Implantable Medical Devices Directive – 90/385/EEC
- Regulation (EU) 2017/746 on Wikipedia
- MDCG 2020-16 Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746
- In vitro diagnostic medical devices and repealing Directive 98/ 79/ EC and Commission Decision 2010/ 227/ EU, Official Journal of the European Union