The Medical Devices Regulation (MDR) foresees a transitional period for medical devices assessed under the previous Directives. With the initial 2024 deadlines and limited conformity assessment capacity, too many devices might have become unavailable on the market. In order to prevent market disruptions and protect patients’ safety, the European Union mobilised and introduced longer transitional provisions.
CE Certificate already expired?
Under certain conditions, medical devices are subject to a longer transitional period and extended certificate validity automatically. Nonetheless, this applies only to medical devices with a CE Certificate that expired from 20 March 2023, the publication date of the new amendments.
Medical devices with a CE Certificate expired before 20 March 2023 have three options if they wish to still place their devices on the EU market:
- Applying for a derogation under Article 59.
- Having a signed agreement with a Notified Body before the Certificate has expired.
- Complete conformity assessment procedure under MDR and obtain MDR CE Certificate from Notified Body.
Application for a derogation
Upon the certificate’s expiration (expired before 20 March 2023), the Authorised Representative of a non-EU manufacturer can apply for a derogation under Article 59. The Competent Authority will evaluate the application and – if they consider that the device does not represent a health and safety risk – can grant a derogation, allowing the manufacturer to keep placing their medical devices on the market for a defined period of time.
Obelis process for a derogation
Obelis, Authorised Representative based in Brussels, Belgium, applies on behalf of the manufacturer for a derogation with the Belgian Competent Authority under Article 59. The Belgian Competent Authority (AFMPS) will assess the application and – based on the data received – evaluate whether to proceed with Article 59. In this case, the manufacturer receives a national derogation under specific circumstances.
Contact us today to learn more about the new legacy period!
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Founded in 1988, Obelis is certified by ISO 9001:2015 and ISO 13485:2016, and partakes in various EU associations and EU commission working groups.
