On 6th January, the European Commission issued a proposal to extend the transitional period under Art. 120 for MDR until 2027-2028: the extension would be necessary to give Manufacturers more time to switch from the previously applicable provisions to the new certification requirements for Medical Devices, as laid down in the Medical Device Regulation.
The overall objective of the extension is to ensure continued access for patients to a wide range of devices, while ensuring the transition to the new regulatory framework and allowing Medical Devices placed on the market, and still available, to remain on the market.
Only devices for which Manufacturers have already taken steps to transition to MDR can benefit from the extension: in particular, the new deadlines depend on the type and risk class of Medical Devices. Specifically:
- Devices with a CE certificate or a declaration of conformity issued before 26th May 2021, including:
- high risk, class III and class IIb implantable devices > for these devices the transitional period is extended from 26th May 2024 until 31st December 2027;
- medium and low risk, class IIb devices and class IIa, Im, Is and Ir devices > for these devices the transition period runs until 31st December 2028;
- custom-made implantable class III devices with a request for conformity assessment by the manufacturer before 26th May 2024 > transition period extended until 26th May 2026.
The application of the extended transition period is subject to several conditions that must occur simultaneously, in particular:
- compliance with Directive 90/385/EEC or Directive 93/42/EEC, as applicable, must be maintained.
- the device must not be subject to significant change in terms of design and intended use.
- devices must not present an unacceptable risk to the health or safety of patients, users or third parties.
- by 26th May 2024, the manufacturer has implemented a MDR-compliant quality management system.
- by 26th May 2024, the manufacturer, or its Authorised Representative, has submitted an application for MDR certification, and by 26th September 2024, the Notified Body and the Manufacturer have signed a written proposal/agreement.
The proposal must now be discussed for approval and co-decision by the European Parliament and the Council.
As far as the European regulatory framework is concerned, four new MDCG guidelines were recently published, in detail:
– MDCG 2022-17 (6th December 2022), a guideline on hybrid audits (in-person and remotely): it defines some operational aspects on the duration and how to carry out ‘on-site’ and ‘off-site’ audits, on Manufacturers’ quality management systems, in the context of first certification and surveillance processes, as set out in Regulations (EU) 2017/745 and 2017/746.
– MDCG 2022-18 (9th December 2022), guideline clarifying market access requirements for legacy devices under Art. 97 MDR: Manufacturers and European Authorised Representatives may request that an EU Competent Authority authorise the sale of devices that are not yet fully MDR-compliant, such as legacy devices that have not yet received EC MDR certification but whose certifications under the MDD or AIMD have already expired.
– MDCG 2022-21 (16th December 2022), a guideline providing different templates and methods for the preparation of the Periodic Safety Update Report (PSUR) according to MDR 2017/745: it applies to Medical Devices certified under MDR and devices certified under MDD 93/42/EEC or AIMDD 90/385/EEC, except for those that were no longer on the EU market before the date of entry into force of MDR.
– MDCG 2022-23 (12th January 2023), guideline providing a list of standard fees to be published by Notified Bodies in accordance with art. 50 of MDR and art. 46 of IVDR: in particular, this document specifies the need for Notified Bodies to make their fees publicly accessible and consultable to any public member without the need for further steps (ref. MDCG 2019-6 section V.2).
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