EMERGO SUMMARY OF KEY POINTS:

• A new interactive online guide from the UK MHRA provides high-level overviews of new European medical device and IVD regulations.
• The new guide should prove useful for CE Mark certificate holders has they prepare for full compliance with the Medical Devices Regulation (MDR 2017/745) and In-Vitro Diagnostic Regulation (IVDR 2017/746).

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has published a new online overview of new European regulatory requirements for medical devices and IVDs.

The MHRA guide, in PDF format, covers the European Medical Devices Regulation (MDR) 2017/745 and In-Vitro Diagnostic Regulation (IVDR) 2017/746. The guide covers key MDR and IVDR issues such as:

• Transition and implementation timeframes
• MDR and IVDR definitions for medical devices and IVD products
• New European classification schemes
• MDR and IVDR conformity assessment requirements
• Unique Device Identifier (UDI) requirements under the MDR and IVDR
• Post-market surveillance and vigilance obligations

One particularly useful section of the MHRA guide addresses the roles of manufacturers, Authorized Representatives, importers and distributors, and delineates the obligations each of these entities will have to meet once the MDR and IVDR are fully implemented in 2020 and 2022, respectively.

Given the major changes the MDR and IVDR will bring about for CE Mark holders in Europe, the new MHRA guide should provide a helpful high-level roadmap for medical device and IVD companies beginning their transition to the new regulations from the Medical Device Directives.

Additional European MDR and IVDR resources:

• European MDR gap assessment and CE Mark transition strategy support
• CE Mark consulting support for medical device manufacturers
• CE Mark consulting support for IVD manufacturers
• Webinar: Europe’s new Medical Device Regulations
• Whitepaper: Understanding Europe’s MDR 2017/745
• Whitepaper: Understanding Europe’s IVDR 2017/746