Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transition

EUROPEAN COMMISSION - Brussel January 6, 2023

Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR) of the European Parliament and of the Council establish a reinforced regulatory framework for medical devices and in vitro diagnostic medical devices. Their objectives are a high level of protection of health for patients and users and the smooth functioning of the internal market for these products. To achieve these objectives and, in light of issues identified with the previous regulatory framework, the Regulations set out a more robust system of conformity assessment to ensure the quality, safety, and performance of devices placed on the EU market.

The MDR has been applicable since 26 May 2021. The transition period provided for in Article 120(3) will end on 26 May 2024.

The IVDR has been applicable since 26 May 2022. In January 2022, the European Parliament and the Council adopted a staggered extension of its transition period, ranging from 26 May 2025 for high risk in vitro diagnostics to 26 May 2027 for lower risk in vitro diagnostics, and to 26 May 2028 for certain provisions concerning devices manufactured and used in health institutions.

Despite considerable progress over the past years, the overall capacity of conformity assessment (‘notified’) bodies remains insufficient to carry out the tasks required of them. In addition, many manufacturers are not sufficiently prepared to meet the strengthened requirements of the MDR by the end of the transition period. This is threatening the availability of medical devices on the EU market.

After the expiry of the certificates issued under the Directives (Council Directive 90/385/EEC on active implantable medical devices (AIMDD) and Council Directive 93/42/EEC on medical devices (MDD)) and without a valid MDR certificate, manufacturers are no longer allowed to place these medical devices on the EU market. This may cause shortages of medical devices, putting patient safety at risk. It is also likely to have a significant negative impact on innovation and business activity in the medical technology sector within the EU. The situation is exacerbated by the impact of the COVID-19 pandemic on clinical investigations, on-site audits and global supply chains, on which Russia’s war of aggression against Ukraine is having a further negative impact.

The overall goal of the proposed amendments is to maintain patients’ access to a wide range of medical devices while ensuring the transition to the new framework. The extension will be staggered depending on the risk class of the device, i.e. until December 2027 for devices with a higher risk and until December 2028 for medium and lower risk devices.

The proposed amendments for Regulations (EU) 2017/745 and (EU) 2017/746 are explained in the following points:

1. EXTENSION OF THE VALIDITY OF CERTIFICATES

This provision amends Article 120(2) MDR. It extends the validity of certificates issued under Council Directives 90/385/EEC or 93/42/EEC 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 extension is directly applicable, so that notified bodies are not required to change the date on the individual certificates. The length of the extension of the certificate’s validity corresponds to the length of the extended transition period laid down in the proposed Article 120 of the MDR. As regards certificates that have already expired when the proposed amendment comes into force, the extension would be subject to the condition that, at the moment of the expiry, the manufacturer has signed a contract with a notified body for the conformity assessment of the device in question. Alternatively, if no such contract has been signed at the moment when the certificate expired, a national competent authority may have granted a derogation from the applicable conformity assessment procedure in accordance with Article 59 of the MDR or have required the manufacturer to carry out the conformity assessment procedure within a specific time period in accordance with Article 97 of the MDR.

2. EXTENSION OF THE TRANSITION PERIOD

This provision amends Article 120(3) MDR. The transition period is extended from 26 May 2024 until 31 December 2027 for higher risk devices (class III and class IIb implantable devices except certain devices for which the MDR provides exemptions, given that these devices are considered to be based on well established technologies) and until 31 December 2028 for medium and lower risk devices (other class IIb devices and class IIa, class Im, Is and Ir devices).

In the same way as the current Article 120(3) MDR, the extended transition period applies only to ‘legacy devices’, i.e. those covered by a certificate or declaration of conformity issued under Council Directives 90/385/EEC or 93/42/EEC before 26 May 2021.

Moreover, the application of the extended transition period is subject to several cumulative conditions, which are:

● the devices must continue to comply with Directive 90/385/EEC or Directive 93/42/EEC, as applicable. This condition is already part of the current Article 120(3) MDR;

● the devices do not undergo significant changes in the design and intended purpose. This condition is already part of the current Article 120(3) MDR;

● the devices do not present an unacceptable risk to the health or safety of patients, users or other persons, or to other aspects of the protection of public health. The concept of “unacceptable risk to health and safety” is set out in Article 94 and 95 of the MDR. No systematic check of the device’s safety is required, as devices covered by a certificate issued under the Directives will be under ‘appropriate surveillance’ by the body that issued the certificate or a notified body designated under the MDR. Where, as part of their market surveillance activities, a competent authority finds that a device presents an unacceptable risk to the health or safety of patients, users or other persons, or to other aspects of the protection of public health, the transition period ceases to apply for that device;

● no later than 26 May 2024, the manufacturer has put in place a quality management system (QMS) in accordance with Article 10(9) of the MDR. This condition aims to ensure that manufacturers gradually move towards full compliance with the MDR requirements. No specific attestation, i.e. no self-declaration nor verification of the appropriateness of the QMS by a notified body, is required at this stage. However, by submitting an application for conformity assessment to a notified body (see next condition), the manufacturer implicitly confirms that its QMS is in compliance with the MDR;

● no later than 26 May 2024, the manufacturer, or its authorised representative, has lodged a formal application in accordance with Annex VII, Section 4.3, of the MDR for conformity assessment in respect of a ‘legacy device’ covered by a Directive’s certificate or declaration of conformity, or in respect of a device intended to substitute that device under the MDR, and no later than 26 September 2024 the notified body and the manufacturer have signed a written agreement in accordance with Annex VII, Section 4.3, of this Regulation. This condition aims to ensure that only devices that the manufacturer intends to transition to the MDR will benefit from the extended transition period. The extension should, however, also apply to ‘legacy devices’ that the manufacturer intends to replace by a ‘new’ device for which it applies for conformity assessment before 26 May 2024. In this way, unnecessary applications for certification of devices that will in any case be phased out and replaced by a new generation of devices will be avoided, whist keeping the existing models available until the end of the transition period.

The devices covered by a certificate issued under the AIMDD or MDD remain subject to ‘appropriate surveillance’ by the notified body that issued the certificate. Alternatively, the manufacturer can agree with a notified body designated under the MDR that the latter becomes responsible for the surveillance. At the latest by the date when the written agreement between the manufacturer and the notified body for conformity assessment in accordance with the MDR needs to be signed, that notified body would by default become responsible for the appropriate surveillance.

The amendment introduces a transition period until 26 May 2026 also for class III custom-made implantable devices, which are currently not covered by Article 120(3) MDR. While manufacturers of class III implantable custom-made devices are required to comply with all applicable MDR requirements since 26 May 2021, they will now be given more time to obtain certification of their quality management system by a notified body. Also in this case, the transition period only applies if the manufacturer has lodged an application before 26 May 2024 resulting in the signing of a contract with the notified body before 26 September 2024.

3. DELETION OF THE "SELL-OFF" DEADLINE IN THE MDR

This provision deletes the current ‘sell-off’ date (27 May 2025) in Article 120(4) MDR. Consequently, devices placed on the market before the end of the transition period can be made further available on the market without a legal time restriction. Articles 122 and 123 MDR will be amended to reflect the extended transition period and the deletion of the ‘sell-off’ deadline.

4. DELETION OF THE "SELL-OFF" DEADLINE IN THE IVDR

This provision deletes the current ‘sell-off’ dates (25 May 2025 to 26 May 2028) in Article 110(4) IVDR. Consequently, devices placed on the market before the end of the transition period laid down in Article 110(3) IVDR can be made further available on the market without a legal time restriction. Article 112 IVDR will be amended to reflect the deletion of the ‘sell-off’ deadlines.

The document in PDF format "Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transition" released by the European Commission can be downloaded by the link here below.