MDCG publishes notice to manufacturers on compliance with MDR requirements

Article summary

The Medical Devices and Coordination Group (MDCG) has published a notice to manufacturers that they should ensure timely compliance with Regulations (EU) 2017/745 (the Medical Devices Regulation (MDR)), before it is fully applicable to all medical devices from 27 May 2024. The MDCG stresses that although a transitional period is provided for in the MDR, it should not be perceived as a 'grace period' to postpone the entering into application of the new rules, and emphasises that from 27 May 2024, medical devices not certified under the MDR will not have access to the EU market. It also states that notified bodies designated under the MDR may not be able to assess all corresponding files within the first months of 2024. In addition, the position paper states that any derogations from the conformity assessment procedure in accordance with Article 59 of the MDR may be granted by competent authorities only if the use of the device...