As we are coming closer to the Date of Application of the Medical Device Regulation (MDR) on 26 May 2020, Agoria would like to inform its members in a 2-day course and communicate publicly about missing elements in the implementation, in a joint action with EU colleagues and EU sector federation, COCIR.
Under the EU MDR there is almost no more class I medical device software because of the interpretation of classification rule 11. (Class I as mentioned in rule 11 is only intended for software accessories that are not a medical device in their own right and that are not intended to drive or influence the use of a hardware device. Independent medical device software is minimum class IIa under Rule 11)
In the practice, this means self-declaration is no longer possible. You need a notified body if you want to continue placing your medical device software on the EU market as from 26 May 2020. The European Commission clarifies in entry #1 of its FAQ on the EU MDR that class I devices cannot use the grace period because these "self-declared devices" lack a valid (MDD) Notified Body certificate. This includes class I devices under the Directives that get a higher class under the MDR. As these up-classified devices cannot use Article 120, the so-called "grace period", their devices require a MDR certificate in May 2020. However, the designation of Notified Bodies is moving slowly and we have heard that many small software manufacturers are struggling to find a Notified Body. One of the topics we would like to address is the challenge manufacturers of current class I software are facing as their devices are up-classified to (at least) class IIa under the MDR.
Call for testimonies
To provide policy-makers with concrete evidence of this problem, we are collecting testimonies from manufacturers in this situation. This problem is EU-wide and therefore we decided to join forces with our EU sector federation, COCIR.
We need your testimonies (named or anonymous). We will provide the collected testimonies to COCIR who will act towards authorities and European Commission to highlight the issue. Agoria will do the same at Belgian policy level.
Send your testimony to firstname.lastname@example.org before June 13th COB.
Need advice in MDR?
Agoria is organizing a 2-day training on MDR, including a specific part on software.
Join us on June 6th & June 13th
You will learn more about:
- Medical device qualification (incl. multi-functionality software or cloud computing and SaS)
- Medical device classification
- How to bring it and keep it on the market legally
- The general safety & performance requirements
- The ISO14971
- The cybersecurity risk management
- and much more..