If you have thoughts about; the MDR transition timeline, Notified Body capabilities, lack of guidance, or heightened requirements for clinical evidence. You’re not alone! And yes we share them too!
A year into the European Union Medical Device Regulation (EU MDR) and the industry is voicing its concerns. Concerns about the unwritten path to compliance. If only there were a “yellow brick road” like in the 1900 children's novel The Wonderful Wizard of Oz. The road functions as a guideline that leads all who follow it, to the road's ultimate destination in this case - Compliance.
Though the MDR can contribute to "A safer healthcare ecosystem", the question remains if it is a curse or a compliment for a medical device? This post highlights the concerns raised by industry experts calling for action from the EU Commission.
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. Clinical data and technical documentation have to be developed and updated to keep new and old devices on the market. During the MDR transition period, manufacturers are to become familiar with the new requirements. And start working toward compliance. However, 15 months into the transition and manufacturers are still struggling. Struggling to understand the regulation and how to adjust to the heightened requirements.
Timeline Feasibility: 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.
Standards and Guidelines: 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.
Eudamed Database: 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.
Notified Bodies (NB): 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.
Grace Period: 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.
With these growing concerns, industry leaders have made calls for a solution. They have requested for a pause on the current transition timeline until the necessary systems are in place or an extension of the current timeline with an agreement on an updated date.
The EU has offered information to medical device manufacturers clarifying the regulatory changes and implementation models to address the changes. The guidelines can become a checklist for companies on their path to compliance. However, there are still numerous concerns and considerations that companies need to take into account, during and after their path to compliance.
Conclusively, it is important to become compliant and even more important to stay compliant.
Take a look at the information provided by the EU Commission: http://ec.europa.eu/growth/sectors/medical-devices/regulatory-framework_en