The Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR) of the European Parliament and Council establish a stronger regulatory framework for medical devices and in vitro diagnostic medical devices. The regulations aim to provide a high level of protection for patients and users and to promote the smooth functioning of the internal market for these products. The regulations have been applicable since 26 May 2021 and 26 May 2022 respectively.
Despite advancements, conformity assessment bodies still lack sufficient capacity, and many manufacturers are unprepared to meet the stricter requirements of the Medical Device Regulation (MDR) by the end of the transition period, putting the availability of medical devices in the EU market at risk. Currently, there are 36 designated notified bodies, with 26 more applications under review.
In October 2022, notified bodies reported receiving 8,120 applications for certification under the MDR and issued 1,990 certificates. The number of certificates issued by May 2024 is estimated to reach around 7,000 if the current rate of certificate issuance remains the same. The transition of all Directive certificates to MDR certificates may be completed by December 2027. However, 21,376 certificates issued under Council Directive 90/385/EEC and Council Directive 93/42/EEC will expire between January 2023 and 26 May 2024, with 3,509 certificates already expired.
The European Commission has put forth a proposal addressing the impending expiration of medical device certificates under the Directives and its potential consequences for patient safety, innovation, and the medical technology industry. To mitigate these effects, they propose amending the transition period for medical device certificates, with the length of the extension being based on the risk level of each device.
The extension is intended to give manufacturers and notified bodies more time to conduct conformity assessments in accordance with the MDR. The extension of the transition period will also be accompanied by an extension of the validity of certificates issued under previous Council Directives, as well as the validity of expired certificates.
The proposal aims to maintain a robust and transparent regulatory framework for medical devices that guarantees a high level of protection for public health and patient safety. The proposal will enhance the oversight of notified bodies to ensure the safety and performance of devices. The proposed amendments to the MDR and IVDR are limited to allowing a gradual phase-in of the requirements for legacy devices and deleting the sell-off deadline.
The length of the transition period will depend on the risk class of the medical devices, with a shorter period for higher risk devices and a longer period for lower risk devices. A transition period is also necessary for class III custom-made implantable devices due to insufficient notified body capacity.
The EU Regulation 2017/745 has been amended regarding medical devices certificates. Certificates that were issued by notified bodies under Directives 90/385/EEC and 93/42/EEC and are still valid on 26 May 2021 will remain valid until specified dates. Devices that have expired certificates can still be considered valid if the manufacturer and a notified body have signed a written agreement for the conformity assessment, or if a competent authority of a Member State has granted a derogation from the conformity assessment procedure. Devices that comply with the Directives and don’t pose an unacceptable risk can be placed on the market until specified dates, provided the manufacturer has put in place a quality management system and has lodged a formal application for conformity assessment by 26 May 2024. The notified body responsible for the appropriate surveillance of the certified devices will continue to be responsible unless the manufacturer has agreed with another notified body.
Here is a synthetic summary:
Regulation (EU) 2017/745:
- Article 120 is amended to allow for certificates issued by notified bodies in accordance with Directives 90/385/EEC and 93/42/EEC to remain valid until certain dates for the relevant risk class of devices.
- Devices are allowed to be placed on the market and put into service until the dates set out in Article 120, provided certain conditions are met.
- Article 122 is amended to repeal Directives 90/385/EEC and 93/42/EEC, with the exception of certain provisions necessary for the application of Article 120.
Regulation (EU) 2017/746:
- Article 110 is amended to allow for devices lawfully placed on the market prior to 26 May 2022 to continue to be made available on the market or put into service.
- Article 112 is amended to allow for Directive 98/79/EC to continue to apply to devices referred to in Article 110 to the extent necessary.
Changes by Class:
- Class III devices and Class IIb implantable devices (except sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips and connectors) may be placed on the market or put into service until 31 December 2027.
- Class IIb devices other than those covered by the point above, and Class IIa and Class I devices placed on the market in sterile condition or having a measuring function may be placed on the market or put into service until 31 December 2028.
- Class III custom-made implantable devices may be placed on the market or put into service until 26 May 2026, provided certain conditions are met.
Proposal for a Regulation of the European Parliament and of the Council amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices : https://data.consilium.europa.eu/doc/document/ST-5585-2023-INIT/en/pdf