The European Union Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) came into effect as of May 26th, 2017. The clock is ticking for current Medical Device manufacturers in the European marketplace to develop and implement strategies to be fully compliant.
The new In Vitro Diagnostic Regulation (IVDR) is complex and the changes it embodies are significant. Our white paper serves as a first step for medical device manufacturers in the EU Market to better understand the immediate IVDR implications by:
- Analyzing the most influential changes and highlighting their implications for regulated medical device companies.
- Providing practical steps that medical device manufacturers should take as soon as possible to prepare for this substantial change in the European regulatory environment.
Maetrics has longstanding experience applying new and complex standards consistently and efficiently while developing compliance strategies critical to your company’s success. Our third party support for MDR, IVDR, MDSAP, ISO 13485, and Supplier Quality Audits can deliver value and objectivity across the whole review and implementation process.
Founded in 1984, Maetrics is a global life sciences consulting firm focused exclusively on regulatory, quality and compliance solutions for Medical Device, Diagnostic, Pharmaceutical and Biotechnology companies.