It’s all happening in the device space. Further to the European Commission’s meeting we discussed last week on the proposed three-year extension to the transition period under the Medical Devices Regulation (EU) 2017/745 (MDR), the EU Medical Device Coordination Group (MDCG) has now published guidance clarifying the use of the non-compliance procedure under Article 97 of the MDR.

Under Article 97, competent authorities can temporarily allow devices that do not comply with the MDR to continue to be placed on the market if they do not present an unacceptable risk to the health or safety of individuals or to public health.

The guidance sets out a uniform approach to the application of the Article 97 procedure for “legacy devices” that do not yet comply with the MDR and whose certificates of conformity issued under the Medical Devices Directive 93/42/EEC (MDD) or the Active Implantable Medical Devices Directive 90/385/EEC (AIMDD) have expired, or will expire before issuance of their MDR certificate.

Key points from the guidance include:

• The use of the Article 97 procedure for legacy devices is meant to be a temporary solution only. Devices that are eligible for this procedure will not ordinarily be granted more than 12 months to come into compliance with the MDR.
• The manufacturer should already have undertaken reasonable efforts to transition its device to the MDR. The manufacturer must have submitted its application for conformity assessment to a notified body under the terms of a written agreement with such notified body. This requirement may be waived in duly justified cases if:
  • the manufacturer is a small and medium-sized enterprise (SME);
  • the certificate of conformity under the MDD/AIMDD was issued by a notified body that is yet to be designated under the MDR; and
  • the manufacturer can demonstrate that it has undertaken reasonable efforts to apply to a considerable number of relevant notified bodies and that the applications have not been accepted due to limited notified body capacity.
• Manufacturers seeking to rely on Article 97 should proactively notify their competent authority (being the competent authority in the member state where the manufacturer or its authorised representative is located) of any forthcoming or incurred non-compliance with the MDR, including details of any relevant data concerning incidents, serious incidents and/or field safety corrective actions for the relevant device.
• The manufacturer or authorised representative of a device that is eligible under the procedure will receive a written communication from the competent authority. The communication will define the duration of the relevant grace period and may set out conditions regarding the manufacturer’s duties and its plan of action to correct the identified non-compliance.
• The competent authority who issued the communication must inform the other EU competent authorities about any devices that it reviews and approves under the Article 97 procedure.  A positive written communication from the competent authority allows the manufacturer to continue to place the non-MDR compliant product on the EU market.  The manufacturer does not need to proactively inform other competent authorities.  Further, the manufacturer does not need to obtain any additional derogations pursuant to Article 59 MDR.
• The Article 97 procedure does not exempt manufacturers or any relevant economic operators from being subject to any other market surveillance activities under the MDR.

This new guidance and last week’s announcement regarding the three-year extension to the MDR transition period are encouraging developments. They indicate that the European Commission is focused on taking proactive steps to resolve the back-log of devices that are yet to transition to the MDR, which are estimated to total around 23,000 devices.