The European Union Medical Device Regulation (EU MDR/IVDR) recognizes historical medical device problems and aims to strengthen regulatory requirements and oversight to foster a more FDA-like regulatory environment. The European Medical Device Regulations (MDR 2017/745) and In Vitro Diagnostic Regulations (IVDR 2017/746) have been entered into force as of May 26, 2017. The Regulations' entry into force is the last milestone before full implementation of the MDR in May 2020 and the IVDR in May 2022. With the regulatory changes resulting from EU MDR and IVDR, manufacturers much be prepared for increased scrutiny of their Clinical Evaluation Reports (CERs).
Finalized in first quarter of 2016, ISO 13485:2016 is one of the most prominent changes within the medical device industry. ISO 13485:2016 specifies requirements for a quality management system to ensure compliance with appropriate standards and impacts companies involved in any stage of the medical device life cycle.
The Medical Device Single Audit Program (MDSAP) allows medical device manufacturers to undergo a single regulatory audit that covers the requirements of several jurisdictions instead of undergoing several audits. This program satisfies all pertinent regulatory parties for medical device companies and encompasses a standardized, global approach to auditing with a focus on reducing the regulatory burden faced by the medical device industry.
MedAccred is an industry-managed supplier quality accreditation program focused on critical manufacturing processes, with objectives of enhancing patient safety, improving product quality, and assuring compliance with applicable requirements. It is gaining tremendous traction throughout the medical device industry, with more and more suppliers taking advantage of the benefits that come from achieving MedAccred accreditation.
Let PRP provide the guidance you need on what to expect. Our subject matter experts can help you navigate these changes by sharing how other medical device & diagnostics companies are approaching these challenges.