Ensuring Compliance: A Guide to Conducting an Effective EU MDR GAP Analysis for Medical Device Companies
The European Union Medical Device Regulation (EU MDR) has brought significant changes to the medical device industry in Europe since it came into effect in May 2021. With the new regulations, medical device companies need to ensure they are fully compliant to continue selling their products in Europe. Conducting an EU MDR GAP analysis is a vital step to assess a company's readiness for the new regulation. In this blog post, we will explore what an EU MDR GAP analysis is, and how it can help your medical device company comply with the new regulation. What is an EU MDR GAP Analysis? An EU MDR GAP analysis is a process that medical device companies use to evaluate their current state of compliance with the new EU MDR regulation. The GAP analysis aims to identify gaps where the company does not meet the requirements of the new regulation. By identifying these gaps, the company can take necessary actions to address them before the regulation’s transitional deadlines. How to Conduct an E