The major areas of change in the MDR include:
- Technical Documentation
- Requirements for clinical evaluation and post-market clinical follow-up
- Increased traceability of devices (UDI)
As manufacturer of medical devices, you must ensure that you meet the relevant regulatory requirements before placing your product on the market.
Medical Device Regulation (MDR) 2017/745
Further Industry and Regulatory Guidance is also available.
BSI the Netherlands is a leading Notified Body (2797) achieving full-scope designation under MDR and IVDR. We are also a full-scope UK Approved Body (0086) assessing medical devices and IVDs against UK legislation. We review your medical device to ensure conformity against the relevant Regulations by offering a range of flexible product review services providing you with efficient pathways to bring your product to the market.
For more information visit our CE marking and UKCA marking dedicated webpages.