BSI Compliance Navigator Bi-weekly Blog: European Union extends validity of certificates issued under Medical Devices Directives

Extension to EU Directives certificates will also apply in Great Britain and Northern Ireland

To maintain patients’ access to a wide range of medical devices while ensuring the transition to the new regulations, the European Union has taken action to extend the validity of certificates issued under the Medical Devices (Directive 93/42/EEC) and Active Implantable Medical Devices Directives (Directive 90/385/EEC). The changes have been implemented by Regulation (EU) 2023/607 of the European Parliament and of the Council of 15 March 2023 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices.

The preamble to this Regulation indicates that it is very likely that many devices that can lawfully be placed on the market in accordance with the transitional provisions provided in Medical Devices Regulation (MDR) ((EU) 2017/745) will not be certified before the end of the transitional period. This would lead to the risk of shortages of medical devices in the EU.

For the extended validity of the certificate to apply, the devices have to continue to comply with the applicable Directives, cannot have undergone any significant changes to design or intended purpose, and cannot present an unacceptable risk to the health and safety of patients, users or other persons, or to public health.

The extension applies to the validity of certificates and declarations of conformity that were valid on the day of the MDR’s date of application (26 May 2021) and have not been withdrawn by a notified body. The period of the extension is staggered depending on the risk class of the device - until December 2027 for devices with a higher risk and until December 2028 for medium and lower risk devices and for devices requiring the involvement of a notified body for the first time (e.g., for class I reusable surgical instruments or software as a medical device). There are further conditions associated with these extensions in order to benefit from the additional time, including requirements for:

• Post-market surveillance
• Quality management systems, and
• Engagement with notified bodies such that the manufacturer has to have taken steps to transition to the MDR.

Unlike the Directives, the MDR requires the involvement of a notified body in the conformity assessment of class III custom-made implantable devices. Consequently, the Regulation also provides a transitional period during which such class III custom-made implantable devices can lawfully be placed on the market or put into service without a certificate issued by a Notified Body.

The Regulation also deletes the deadline in both MDR and IVDR for making available of devices which are placed on the market before or during the transition period and which are still in the supply chain when the extended transition period is over.

The UK Medicines and Healthcare products Regulatory Agency (MHRA) have indicated that these extensions apply automatically in Northern Ireland. In addition, they have said that certificates that have been extended will also be recognised as valid for placing CE marked devices on the market in Great Britain (England, Scotland and Wales).

Manufacturers should review the amending regulation and associated conditions in detail, ensure that they are in communication with their notified body, and are taking timely action regarding the conformity assessment of any devices that could be subject to the extended transition. 

The Compliance Navigator blog is issued for information only. It does not constitute an official or agreed position of BSI Standards Ltd or of the BSI Notified Body.  The views expressed are entirely those of the authors.

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