Asset Publisher

null EU-level solutions proposed to challenges of availability of medical devices

EU-level solutions proposed to challenges of availability of medical devices


Legislation on medical devices has changed significantly since the regulation on medical devices (EU) 2017/745 (MD Regulation) and the regulation on medical devices used in in vitro diagnostics (EU) 2017/745 (IVD regulation) took effect. These changes also affect medical devices that are already on the market, which must be updated to correspond to new requirements.

One of the upcoming key challenges facing the implementation of the MD and IVD regulations involves capacity problems for the required outside inspection body (Notified Body NB) for the evaluations that are required for the certification that devices of the higher class should meet the standards that are set. It has become increasingly apparent that Europe does not yet have enough notified bodies for the evaluation of all devices in accordance with the new requirements in the regulations, which means that availability problems could emerge with some devices.

Fimea has participated actively in the assessment work on finding EU-level solutions to a challenging and complex situation that ensure patient safety. Possible solutions to reduce the availability risk have been discussed intensely with officials and stakeholders in the different member states.

Applying Article 97 of the MD Regulation on controlling availability

One possible partial solution to the situation would be to apply Article 97 of the MD Regulation to cases in which a device that would otherwise meet the requirements would not be getting the certificate in accordance with the new regulation in time due to reported capacity problems of the assigned institutions. The Commission and the member states share the view (MDCG 2022-18) that in situations in which a device or manufacturer has a certificate under Article 120(3) of the MD Regulation in accordance with the MD Directive 93/42/EEC or the AIMD Directive 90/385/EEC, and if certification in accordance with the MD Regulation cannot be achieved before the deadline set for the certification (26 May 2024), the official supervising the manufacturer may, in certain conditions, enact a process set in Article 97.

In situations in which it is recognised that a medical device does not pose an unacceptable risk to health, security, or other risk to aspects targeting public health, even if it does not meet all requirements of the regulation, a competent official of a member state may, based on Article 97, give the manufacturer a deadline for correcting the failure to meet the requirements.

When applying the process set by Article 97 because of the expiration of a certificate, the manufacturer must provide evidence that active measures have been launched for getting an MDR certificate - i.e. that an agreement with the assigned institution has been made, even if the certification process has not yet begun. In addition, the manufacturer must supply the supervisory authority with a report on the follow-up after the device has been put on the market, especially concerning dangerous situations, and to be capable of showing that the quality system corresponds to the requirements of the MD Regulation. An instruction given in a table included in an appendix to MDCG 2022-18 gives the needed documents to support the processing of the matter. If all the set conditions are met, the authority has the discretion to set a deadline for bringing the certification to a conclusion. The authority is responsible for communicating the matter to the other member states, and the manufacturer is responsible for communicating the matter on its own distribution routes.

Situation and measures taken in Finland

There are currently two institutions situated in Finland that have been reported in accordance with the MD Regulation. There are currently no institutions in Finland reported in accordance with the IVD Regulation.  A reported domestic institution is not available for all groups of devices, and a European-wide capacity problem also affects Finnish manufacturers of medical devices.

Fimea is the authority that oversees medical devices in Finland, and it is responsible for the process under Article 97 that was described above involving Finnish equipment manufacturers.

Many manufacturers in the EU area have applied for a derogation under Article 59 of the MD Regulation to secure the availability of their devices also in situations in which the certificate is set to expire. No separate derogation process is needed if the matter is processed according to Article 97. Regardless of how the matter is handled, Fimea must ensure the safety of the devices for the patients, so it is good to reserve adequate time for the process.

Read more

MDCG 2022-18 MDCG Position Paper on the application of Article 97 MDR to legacy devices for which the MDD or AIMDD certificate expires before the issuance of a MDR certificate

Regulation (EU) 2017/745 (Eur-Lex) of the European Parliament and of the Council of 5 April 2017 on medical devices

MDCG 2021-25 Regulation (EU) 2017/745 - application of MDR requirements to ‘legacy devices’ and to devices placed on the market prior to 26 May 2021 in accordance with Directives 90/385/EEC or 93/42/EEC


Ask more

  • Hanna-Maria Matinolli, Coordinator
  • The e-mail takes the form
  • Questions about processes according to Article 97 and derogations: