Heading - Changes in Medical Device Regulatory Requirements in Europe (2021) In May 2021, the new European regulations on medical devices (EU MDR) will take full length. This is new extended date due to Pandemic (original date was May 2020) Companies face a unique set of compliance challenges, mostly due to the many changes and additions to the Medical Device Regulation related to its Medical Device Directive predecessor. For the record, the complete document is nearly 3 times longer. What should you be aware of to successfully place your device(s) on the European market? How can you prepare to efficiently implement all new directives? How do those changes affect your resources in terms of personnel, time constraints, and budgets?
MDD to MDR what has changed? New Classification - Some devices may now belong to a new, higher-risk class, forcing manufacturers to adhere to stricter standards. 1. 2. 3. 4. 5. 6.
Unique Device Identification (UDI) Labelling, packaging & instructions language Legacy devices Clinical evaluation Post-market surveillance and risk management Data transparency and accessibility
Above labels of topic may look simple but have wide ramifications and MDR gives guidelines for doing so. Apart from this new Brexit also becomes effective from 1Jan 2021, so UK will be separating from EU hence as earlier EU MDR regulations would have been applicable to UK also but now UK has already published new guideline in September 2020, detailing how devices will be regulated beginning January 1, 2021. This guideline gives varied compliance dates based on classification of devices. Those who are dealing with UK must take care of this aspect also.