The new European Medical Device Regulation (EU MDR) is on its way. Soon, medical device manufacturers wishing to submit to European markets will need to comply with a set of new and critically important regulations. However, even with the 2020 deadline coming up, many organizations are still in the dark about what the MDR is and what it means for them. Here are some common questions we’ve heard about this new European regulation and what it means for your product development and compliance activities.
What is EU MDR?
Replacing the EU’s previous Medical Device Directive (MDD), the MDR is a new set of regulatory guidelines for medical devices submitted for marketing in the European Union. This new regulation consolidates some of the MDD’s regulatory oversight into two domains: medical devices and in vitro diagnostics.
When will my organization need to comply with the new regulation?
The MDR regulation was first published and put into effect back in May of 2017. After publication, the EU designated a three-year transition period for medical device industries and five years for IVD manufacturers. Medical device organizations must be in compliance with the MDR when it is fully enacted in May 2020.
Why was the existing EU regulation updated?
There are a multitude of reasons the EU opted to change and update the MDD and switch to the new MDR rules. Chief among them are an increasing focus on patient safety, product effectiveness, and improved regulatory oversight. In the past several years, a number of adverse incidents and issues with notified bodies have taken a toll on consumer confidence. With the MDR, the EU hopes to keep better tabs on the postmarket environment while ensuring submitted products meet new quality standards.
If my product was already cleared through MDD, is it grandfathered in?
Unfortunately, the MDR excludes the grandfathering of all medical device and IVD products. Even products that have been on the market for over 20 years will require a new CE mark once the new regulation is fully in place. Manufacturers need to submit the appropriate documentation for their new CE mark, particularly technical data relating to postmarket surveillance.
Do device classifications change under MDR?
For the most part, device classification will not be impacted in a significant way once the MDR is carried out. However, Class I device manufacturers need to change their approach to compliance. According to Article 10, paragraph 9 of the MDR, these manufacturers must establish and document a formal quality management system (QMS). Come May 2020, organizations producing Class I devices need to have a robust QMS in place—same as their peers who make higher-risk devices. The MDR suggests manufacturers rely on industry standards such as ISO 13485:2016 when developing and operating a quality system.
Will my risk management activities have to change at all?
Manufacturers looking to comply with EU MDR do not necessarily have to alter the risk management activities they do. However, the data they provide will change with rule implementation. The EU wants to see more in-depth clinical data that proves claims of performance and safety, along with having tighter equivalency standards. For the postmarket environment, there are a number of risk-related rules medical device organizations must comply with. Manufacturers are required to have documented surveillance plans in place, for example. Also, reporting times for incidents have been shortened, and that data needs to be fed into a new, publicly available database for consumers.
