The market for medical devices in the European Union was worth $140.07 billion in the year 2022 and is expected to grow at a CAGR of 4.09% to reach $171.19 billion by 2027. One of the primary factors fueling this growth will be the population of Europeans above the age of 65, who already account for over 20% of the European population. Hence, medical device manufacturers need to take all possible steps to ensure that they enjoy access to the European market, chief among these steps being compliance with the latest EU MDR.
The EU MDR primarily aims at improving the traceability of a medical device from its development to expiry and has introduced new levels of complexity to the regulatory process, which are starkly different from those of the regulations by the FDA or other regulating bodies for medical devices in other markets. The complexity of the regulatory documents is further exacerbated by the interconnectedness of some of the required deliverables, including the clinical evaluation plan (CEP), clinical evaluation report (CER), period safety update report (PSUR), post-market clinical follow-up (PMCF) evaluation report, and the Summary of Safety and Clinical Performance (SSCP).
How can we avoid inefficiencies and inconsistencies that might creep into our documents with incomplete knowledge of the interconnected nature of these deliverables? How to avoid all these pitfalls and keep thriving in the EU Medical Devices market?
Download our handy guide to understand the overlaps in the regulatory documentation and how to avoid being overwhelmed and ensure that your product passes through the regulatory body with the minimum amount of fuss.