Das EU-Parlament stimmte am 16.02.2023 dem von der EU-Kommission vorgelegten Änderungsentwurf der Medizinprodukteverordnung (MDR) zu.

The abolition of the sell-off period and an extension of the transition period for existing products in line with a risk-based approach are causing many manufacturers to breathe a sigh of relief. It remains important not to lose sight of the requirements that continue to apply.

At this point, we would like to emphasise the part of the amendment that relates to Medical Devices which must be classified higher by the ordinance:

Change to Article 120 of EU 2017/ 745 for medical devices:

Devices that have been classified as risk class 1 in accordance with Directive 93/42 EEC (...) and for which the conformity assessment procedure in accordance with EU 2017/745 requires the involvement of a notified body can now be placed on the market or put into service until 31 December 2028.

However, the following conditions still apply:

• These products continue to comply with Directive 93/42/EEC.
• A corresponding declaration of conformity was issued before 26 May 2021.
• There are no significant changes to the design and purpose.
• The products do not present an unacceptable risk to the health or safety of patients, users, other persons or to other aspects of public health protection.
• The manufacturer shall have established a quality management system in accordance with Article 10(9) by 26 May 2024 at the latest.

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