Key points: 

• The journey of the EU Medical Device Regulation (MDR) has been marked by continuous amendments and a lack of stability, leading to significant uncertainty for the industry and impacting the EU’s competitiveness as a primary market for innovation 
• There is a strong call from industry for the upcoming legislative proposals to introduce a more predictable, harmonised and efficient framework, with key suggestions including the abolishment of recertification in favour of a true lifecycle approach 

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