On 25th May 2017, new Regulations on Medical Devices (MDR)- Regulation (EU) 2017/745 – and in vitro Diagnostic Medical Devices (IVDR) -Regulation (EU) 2017/746 entered into force in the European Union.
This new regulatory framework will only apply after a transitional period of 3 years for MDR (2020), now extended to 2021, and 5 years for IVDR (2022).
Economic operators (manufacturers, authorised representatives, importers and distributors) are called to fulfill the obligations settled in the Regulations in order to place an MDR/IVDR compliant device on the market.
If you are looking for support on any of the following matters, please contact us and we will provide you with specific details of these services:
- Implementation of Medical Devices Regulations (MDR & IVDR)
- Technical documentation and other reports
- Quality Management System; internal/external audits, MDSAP Programe
- Vigilance and post-market surveillance
- Risk Management
- Clinical Evidence: Clinical and Performance Evaluation
PERSON RESPONSIBLE FOR REGULATORY COMPLIANCE (PRRC)
- We ensure an experienced qualified PRRC as laid down by Regulation (EU) 2017/746 and Regulation (EU) 2017/745.
- If you are looking for an PRRC, please send an email to info@affixcompliance.com and we will provide you with detailed information of this service.
Affix Compliance 