During the Council of the European Union meeting on December 9, 2022 devoted to the Employment, Social Policy, Health and Consumer Affairs (EPSCO), the European Commissioner for Health and Food Safety gave an update on the implementation of the medical devices (MDs) and in vitro diagnostic medical devices (IVDs) regulations, in particular on the work in progress related to the guide MDCG 2022-14. The Commissioner also announced that a draft amendment to the MD regulation would be published in early 2023 and put to a vote in Parliament.
This amendment aims to prevent the risk of disruption of medical devices availability on the European market whose directive certificates would expire before regulation certificates are obtained. As a reminder, this deadline is currently set at the latest on May 26, 2024, as defined in Article 120 of Regulation (EU) 2017/745.
Unlike the amendment adopted in 2020 at the height of the health crisis, where the date of application of the regulation was postponed by one year for all medical devices, the announced amendment will only focus on medical devices placed on the market before May 26, 2021. These could have their directive certificate validity extended beyond May 26, 2024 and at the latest in 2027 for class III and IIb devices and 2028 for class IIa and I devices that are subject to a Notified Body (NB) conformity assessment, under the following conditions:
- Not to present unacceptable risks to health and safety;
- Not be subject to significant changes in design or purpose;
- The manufacturer has undertaken a certification process under the Regulation such as the adaptation of its QMS and the submission and/or acceptance of an application for conformity assessment by a NB (a priori by May 26, 2024 at the latest).
This amendment will allow both manufacturers and NBs more time to conduct the conformity assessments required under the MDR and free up capacity to deal with the assessment of new MDs. However, we urge of all manufacturers to the importance of not easing the effort to transition to the regulations. Indeed, the conditions for extending the validity dates of directive certificates and the associated restrictions remain to be specified, particularly with regards to MDs that may be subject to significant modifications.
The majority of Member States support these proposals and wish to see them implemented as soon as possible. During this transition time, it has been proposed to harmonize the application of the Article 97 of Regulation (EU) 2017/745 at the level of the Competent Authorities, which should reduce the risk of rupture of MDs with expired directive certificates. The full provisions are published in position paper MDCG 2022-18. A new element to be noted in relation to the practices observed: A single competent authority intervenes and the application of article 97 can then be used to gain market access of the medical devices concerned in all Member States.
GMED remains fully mobilized within the framework of its responsibilities to support all its customers and manufacturers in their certification process.
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