IVDR Compliance: What You Need To Know
The In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR) establishes the regulatory framework for in vitro diagnostic medical devices. Several transitional provisions must be taken into consideration and many challenges lie ahead. Download our latest whitepaper to stay compliant with what you need to know.
This whitepaper covers:
The In Vitro Diagnostic Regulation (IVDR), transitional provisions, associated guidance documents and explores the challenges ahead, including;
- Regulation (EU) 2017/746 on in vitro diagnostic medical devices
- S.I. No. 256/2022 – Ireland In Vitro Diagnostic Medical Devices Regulations 2022
- MDCG 2022-8 Regulation (EU) 2017/746 – application of IVDR requirements to ‘legacy devices’ and to devices placed on the market prior to 26 May 2022
- MDCG 2022-6 Guidance on significant changes regarding the transitional provision under Article 110(3) of the IVDR
Denise McDermott, Senior Compliance Specialist, Compliance & Risks
Prior to joining Compliance & Risks, Denise worked in the medical device industry for 13 years across a number of areas including regulatory affairs, post-market surveillance, customer complaints, quality, and technical support.
She has experience in several areas including IVDR, CE marking, labeling, legal documentation, customer and quality technical communications and regulatory risk assessments.