EU Medical Device Regulation (MDR)

Medical Device Regulation (MDR)

A regulation that governs the production and distribution of medical devices in Europe, called EU Regulation 2017/745 on Medical Devices, went into effect on 26 May 2021.

The new EU MDR regulation includes several important improvements that were necessary to ensure a high standard of safety and quality and include:

• Stricter control for high-risk devices via a new pre-market scrutiny mechanism involving a pool of experts within the EU
• Reinforce the designation and process criteria for oversight of notified bodies
• Addition of certain aesthetic devices that share similar characteristics and risk profiles as analogous medical devices
• A new risk classification system for in vitro diagnostic medical devices in line with international guidance
• Improved transparency through a EU database (EUDAMED) and device traceability based on new device identification
• Additional rules on clinical evidence and post-market surveillance requirements for manufacturers

Benefits of the MDR include improved coordination between countries in the EU around vigilance and market surveillance, which will provide more consistent confidence in the patient experience across the EU.

As with any new regulatory requirements, challenges exist to comply. A new software-specific classification rule moves some class 1 devices into the higher risk classes II or III (Rule 11). Given this change, these devices will now require a Notified Body conformity assessment. This puts a heavy burden on Notified Bodies to meet market demand.

BrightInsight has been preparing for May 26^th, 2021 since 2018. That’s why it is business as usual for our customers in the EU. We have made the proper provisions and are meeting with regulators on behalf of our clients. We have assured our medtech and biopharma clients from the start that BrightInsight reduces the regulatory burden and this is a perfect example of how we do this.

More details about BrightInsight’s EU MDR compliance:

• BrightInsight understands the legal, privacy and security, and local market requirements of the region and has made the necessary adjustments to our digital health platform and Quality Management System to meet the new MDR requirements.
• Our team also determines the regional and data residency requirements of each market, bringing in local partners, if needed.
• To be compliant with EU MDR, BrightInsight harmonized our ISO 13485:2016 certified Quality Management System to the EU MDR requirements.

BrightInsight’s Notified Body, TUV SUD, is an independent, non-governmental trusted partner of choice for safety, security and sustainability solutions.