One month from today, on 26 May, medical device regulations in the European Union will become a bit more complicated when EU Regulation 2017/745 on Medical Devices goes into effect. The updates and changes in legislation reflect the wealth of industry advancements over the last 20 years and, among other changes, will impact how devices are classified.
These new EU MDR regulations include several important improvements that were necessary to better address current market dynamics and include:
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 by the deadline. 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 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.
We have been preparing for May 26th, 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.
We are ready for EU MDR and, more importantly, we will partner with medtech and biopharma companies to make sure they are also prepared and experience little, if any, disruption.