IVDR (In Vitro Diagnostic Regulation) impacts all in vitro devices sold in EU markets. Learn what this means for you.
Medical device regulations are undergoing a period of substantial change at a level never experienced before by this growing industry. ISO 13485:2016, EU MDR, MDSAP, and MedAccred are all garnering the attention of Quality and Regulatory Compliance leaders worldwide. If that weren’t enough, the industry now must also tackle Regulation (EU) 2017/746 of the European Parliament and of the Council on in vitro diagnostic medical devices, otherwise known as IVDR.
IVDR, which was published in May 2017, repeals the EU’s previous directive on in vitro diagnostic medical devices (98/79/EC). It carries a 5-year transition period, thus requiring manufacturers of currently approved in vitro diagnostic medical devices to comply by May 26, 2022. Once the transition period has ended, all in vitro devices will need to adhere to IVDR in order to be sold in EU markets. This may seem like a long way off, but with 113 Articles and 15 Annexes, the IVDR requires significant changes that will make the transition process for most companies very time-consuming. Consequently, manufacturers need to start addressing IVDR now to ensure they don’t end up in crisis mode come 2022. Here are 5 of the more noteworthy points addressed in the IVDR:
As explicitly stated in the IVDR, this new medical device regulation “sets high standards of quality and safety for in vitro diagnostic medical devices in order to meet common safety concerns…”. The previous directive was widely viewed as stale and outdated, and therefore a change to a new regulation, more in touch with today’s medical device market, was necessary. Due to the volume and complexity of the new medical device regulation, many manufacturers have already begun conducting their gap assessments to determine specifically where their current processes fall short as compared to the new requirements. From there, Quality and Regulatory Compliance leaders will need to determine the specific action steps, and the resources needed, to achieve compliance in a timely manner. The key to your successful transition to IVDR – start early, plan effectively, and get the help and expertise you need.