Timelines and validity of certificates in the light of the new Medical Devices Regulation
What is the validity of certificates issued by Notified Bodies and how long can the related Medical Devicess be marketed? What are the rules of the transitional period? The companies in the medical devices sector have many questions concerning the implementation of the new Regulation on medical devices.
Months are going by fast, and the application date (26 May 2020) of the EU Reg. 2017/745 (MDR) is approaching. One of the questions that manufacturers of medical devices frequently ask, concerns warehouse management. From a strictly legal viewpoint, the question actually is: what is the period of validity of the certificates issued by the notified bodies according to Dir 93/42/CEE (MDD) or Dir 90/385/CEE (AIMDD)?
Also, for how long can the relative medical devices based on these certificates be put on the market? In other words: what are the rules governing the transitional period? The provisions for the transitional period are found in Art. 120 of the MDR. Being this a very complex article, the European Commission had prepared in November 2018 the infographic below (for reasons of space we have removed the part Ivd) and also the Camd - Competent authority for medical devices draw up the Faq calls (note) Faq - Mdr transitional provisions. In short, two periods can be identified.
Before 26 May 2020
Before 26 May 2020, all Medical Devices with a certificate issued by a Notified Body in compliance with the MDD/ AIMDD may still be lawfully placed on the market. The Regulation does not exclude, however, that before 26 May 2020 manufacturers can place on the market medical devices manufactured according to the new certificates issued in compliance with the MDR. This may take place after the designation of the first Notified Bodies by the competent authorities. At the moment, however, no Notified Body has been designated in accordance with the new Medical Device Regulation.
After 26 May 2020
After 26 May 2020, it will still be possible to place on the market products based on certificates that are compliant to the previous MDD/ AIMDD (and therefore sell the devices already present in the warehouse), taking into account the following rules on the validity of certificates (Article 120 paragraph 2).
- Certificates issued by Notified Bodies in compliance with the MDD/ AIMDD before 25 May 2017 (publication date of the MDR in the Official Journal) remain valid until the expiration of the term indicated on the certificate (Article 120 paragraph 2). Exceptions are certificates issued in accordance with Annex IV of AIMDD or Annex IV of the MDD, which will cease to be valid on 27 May 2022 at the latest;
- Certificates issued by Notified Bodies in accordance with the MDD/ AIMDD after 25 May 2017, remain valid until the end of the period indicated on the certificate (5 years), but in any case no later than 27 May 2024.
In view of the foregoing, the manufacturer who intends to place on the market devices issued on the basis of certificates compliant to the MDD/ AIMDD after 26 May 2020, will still have to comply with the following requirements (Article 120 paragraph 3):
- Devices must remain in conformity with the MDD/ AIMDD
- Manufacturers must avoid making significant changes in the design and functionality of their devices and
- The devices must in any case be compliant with the MDR with regard to post-marketing surveillance (Article 83 and ff.), market surveillance measures (Article 89 et seq.) registration of economic operators and devices (Article 92 et seq.).
However, there is a critical aspect that is related to these requirements: since the Notified Body is responsible for the surveillance of all the above requirements (therefore those ex-MDR) the feasibility of this option is not certain, if the NB fails to be designated according to the MDR. In which case, it would be necessary to change the Notified Body, which would certainly add to the complexity of the case.