On March 20, 2023, Regulation 2023/607 was published in the Official Journal of the European Union – EUR-Lex (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) which formalises and makes immediately enforceable the extension to 2027-2028 of the transitional period provided for in Art. 120 MDR (EU) 2017/745.
The proposal to postpone the deadlines comes with the overall objective of ensuring patients’ continued access to a wide range of devices, while ensuring the transition to the new regulatory framework and allowing Medical Devices that have been placed on the market, and are still available, to remain on the market.
Moreover, please note that the extension is only valid for legacy devices, i.e., those requiring or that will require the intervention of a Notified Body. As for Class I devices (self-declaration ones) that will remain so, MDR is already fully applied as of 05/26/2021.
Regulation 2023/607 stipulated that Medical Devices with an EC certificate or EC Declaration of Conformity AIMDD or MDD issued before May 26, 2021, and not yet expired may be placed on the market or put into service up to certain dates under the following conditions:
- compliance with Directive 90/385/EEC or Directive 93/42/EEC, as applicable, must be maintained;
- the device must not be subject to a significant change in terms of design and intended use;
- the devices must not present an unacceptable risk to the health or safety of patients, users or third parties;
- by May 26, 2024, the manufacturer must have implemented an MDR-compliant quality management system;
- by May 26, 2024, the Manufacturer or its authorised representative must have applied for MDR certification, and by September 26, 2024, the Notified Body and the Manufacturer must have signed a written proposal/agreement.
Consequently, by May 26, the manufacturer must have implemented an MDR-compliant quality management system and an application for MDR certification.
>>> Through the services of EC certification and if necessary, a European Authorised Representative, Thema can help you implement the requirements of the MDR (EU) 2017/745.
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