The EU MDR is a new medical device regulation that affects all medical devices placed in the European market. It was introduced in 2017 to replace the existing Medical Device Directive (MDD). Any medical device company that wants to sell their products in the market must now comply with the MDR 2017/745 to obtain a CE mark. Existing medical device manufacturers that already are in the market must upgrade their technical documentation and processes in accordance with the new regulation, the deadline for which is 26 May 2020.
Any medical device that is sold in the EU region needs to have a CE Mark. The EU has designated Notified Bodies that are authorized to certify medical device manufacturers. With the overall aim of improving safety and performance, the new regulation includes changes to technical file documentation, claiming equivalence, clinical evaluation, device classification and post-market surveillance.
EU MDR: Resource Crunch
Even though the deadline is only a few months away, there is uncertainty among regulatory professionals and medical device companies about what it actually means. There is a severe resource crunch in the industry of professionals who can understand and implement MDR regulatory compliance.
To put things in perspective: There are around 27,000 medical technology companies in Europe, of which 95% are small and medium-sized companies (SMEs). Many of these companies may not have in-house resources to keep up with the requirements of the MDR. If they don’t comply, they risk their product being taken off the EU market entirely.
One of the reasons for the rapid growth of SMEs in the medical device industry is also the rate of innovation. Between 2007 and 2017, the number of European patent applications for medical technology increased by around 50%.
Barriers to EU MDR compliance
The EU MDR is one of the biggest changes to medical device regulations in over 20 years. Several medical device companies are finding themselves short of resources and expertise to meet the new requirements. Some of the challenges companies are facing include:
Lack of clarity in the regulations
A recent survey carried out by RAPS/KPMG surveys shows that over 78% of medical device companies don’t understand the EU MDR fully. The changes are extensive, and require organizations to develop a comprehensive plan to prepare for the full implementation of the MDR. Many of the changes affect several functions not just within an organization but also with their business partners and Notified Bodies.
Freelance clinical evaluation report writer Basak Erpolat says,
“Medical device manufacturers still don’t understand MDR requirements and the seriousness of the timeline. The document everyone is struggling with appears to be CERs and the requirement on ‘sufficient clinical evidence’.” Erpolat also emphasizes that it’s become much harder for medical devices to claim equivalence — which presents a crisis for manufacturers who don’t have enough of their own clinical data for low-risk devices.
Lack of access to skilled professionals
The pool of expert professionals who can help with MDR implementation is significantly smaller than
the pool of medical device manufacturers who need them. Access to skilled professionals are one of the biggest challenges that medical device SMEs face. Kolabtree has seen a rise in the number of projects that seek freelance CER writers for various classes of medical devices, including high-risk devices. While established companies may be afford in-house expert teams, SMEs are looking to work with consultants on an on-demand basis.
Delay in designation of Notified Bodies
Many existing Notified Bodies are overloaded and are struggling to keep up with the workload. There has also been a delay in designated NBs, which has made the waiting period even longer for manufacturers. As of Jan 2020, only 9 out of 55 Notified Bodies were approved for MDR certification. The RAPS/KPMG survey also reported that 35% of organizations felt that the lack of Notified Bodies was a barrier to compliance.
Given the time and cost investment involved in meeting the MDR requirements, manufacturers are starting to also look at alternative markets such as China and Korea where they can launch their products easily and quickly. The RAPS/KPMG reported that 43% of medical device manufacturers plan to withdraw from the EU market.
Working with MDR consultants
The lack of easy access to MDR experts is a serious obstacle for medical device SMEs, and the additional constraints of budget and timeline can define their ability to survive in the EU market. However, using on-demand platforms and outsourcing tasks to experts directly is one way of solving the skills gap.
Erpolat explains that she’s noticed a steep rise in the demand for clinical evaluation report writers across medical device classes, including those in the software-as-a-medical-device category. Every medical device requires a CER document, which comprises all clinical data evaluation information, safety and performance instructions, literature reviews and more. Hiring freelance specialists for this task can save medical device manufacturers precious time and money, while reducing the risk of them being taken off the market.
Many SMEs are also simply unsure of the way forward. While there are established organizations who offer regulatory compliance services, they also involve more complex processes and contracts. The availability of MDR consultants on Kolabtree who can directly advise on a regulatory strategy, EU MDR gap assessment or solve specific questions makes the process easier, quicker and painless.
Need help with regulatory compliance for your medical device? Speak with a medical device EU MDR compliance expert on Kolabtree or work directly with a freelance clinical evaluation report writer. It’s free to post your project and get quotes.