MDR 2020 – the changes and what it means to the industry

MDR (medical device regulation) – Things you need to know!!

Now that the MDR is in effect, What are the growing concerns within the industry? and what do the experts have to say about it?

One of the more comprehensive changes brought about by the MDR is increased focus on clinical evaluation, post-market surveillance, and access to data. This places a higher strain on both regulatory and clinical operations. During the MDR transition period, manufacturers are to become familiar with the new requirements.

What are the concerns?

There has been a lack in development of the promised regulatory systems. This has the industry questioning the feasibility of the transition timeline. The possibility of new and existing devices not reaching the market (and thereby patients), due to failed (re)certification, is becoming more probable as the transition deadline comes closer.

These are needed for the industry to understand and develop their path to compliance. The lack of guidance on the applicability means different interpretations of the MDR text.  This in turn leads to more uncertainty and chaos.

This new database for medical devices should be ready on time to strengthen market surveillance and transparency. And to contribute to a uniform application of the regulations. The Eudamed is set to be ready March 2020, however, there is uncertainty surrounding timely access to it.

The lack of skills and resources on part of the Notified Bodies has a huge impact on the overall transition. If the NB’s cannot possess the required expertise and resources to manage the workloads in time, manufacturers will risk a great delay in certification. To date, industry professionals have already reported waiting time of many months to receive any feedback or response from a designated NB. The (re)designation process will take 18 months on average per NB.

The grace period allows for certain devices to remain on the market with a valid certificate issued during the transition period. But the renewal of such devices will need to comply with the current MDR. This creates more strain on the NB’s as they will have to deal with the renewal of these products in addition to their existing tasks.

The European MDR is a taste of how the regulatory environment for medical devices will be changing over the next decade. The newly published ISO 13485:2016 and the MDSAP program are already pushing for greater standardisation and stronger post-market surveillance requirements, along with process-oriented risk management and a life-cycle approach to device management.

Although the effective date for the MDR feels far in the future, compliance today promises to set your medical company up for long-term industry prosperity and unprecedented success in meeting regulatory compliance objectives in valuable markets around the world.