It needs little explanation that the MDR and IVDR are keeping people busy since a few years already. Not only manufacturers, but as well Notified Bodies, accreditation bodies, competent authorities...everyone.
Ever since the texts of the MDR and IVDR have been published, lots of comments and insecurities have been outed. Warnings about how innovation will be killed, manufacturers will avoid the European market,... lots of doom scenarios.
As a short reminder, this is what the timeline for transition looked like:
In this blog post we zoom in into two of the latest documents posted related to the actual situation "in the field". The field of the manufacturers as well as the field of the Notified Bodies themselves.
In July 2022, MedTech Europe published the results of a survey they conducted with medical device manufacturers, out of data gathered in April 2022. This survey represented an estimated 60-70% market revenue coverage. It was completed by both large companies as well as Small and Medium Sized Enterprises (SMEs).
The main conclusions of this survey were:
- More than 85% of the devices certified under the MDD and IVDD still need to be certified under the MDR/IVDR
- Time-to-certification is taking 13-18 months on average with MDR-designated Notified Bodies
- More than 50% of the respondents plan portfolio reductions
- Up to 30% of SMEs do not have access to an MDR-designated Notified Body
- Approximately 50% of the respondents are deprioritising the EU market for first regulatory approval of their new devices
This clearly shows that the industry is struggling. The impact seems higher on smaller companies as compared to larger ones. Companies are actively considering discontinuing certain products on the European market and the time-to-market for new devices has doubled compared to how it was under the directives. So far the gloom and doom scenario seems to become truth.
Recently, the European commission published the results of a Notified Body survey. This survey was conducted in October 2022.
Some interesting take-aways from this survey related to medical devices are the following:
- Most of the current certificates under the MDD are still valid till 2024 (Note that on May 26th 2024 all remaining existing CE certificates under the old directives will expire)
- The number of applications for certification is growing more rapidly than the number of certifications
- The main reasons for refusal of applications are:
- Outside of the scope of notified body's designation
- Insufficient notified body resources
- In most cases, the time to reach certification for product+QMS is 13-18 months, or even up to 24 months
In conclusion, we can say that the situation doesn't seem to have dramatically improved. The time-to-certification has not shortened in the last 6 months and both sides are struggling. Manufacturers have difficulties compiling complete files according to the requirements of the MDR and Notified Bodies are short on resources and expertise to review them in a timely matter.
In the meantime, new mdcg guidance documents are being published to "help" create more clarity. This is a good thing, but it also seems to create more confusion. Files need to be adapted accordingly. Findings are raised because of new guidances that might not have existed at the time of application.
Before publishing this article, there was a new publication after the EPSCO meeting on December 9th. New timelines have been proposed to replace the ones at the start of this article:
⮚ an extension of the transitional period in Article 120(3) MDR with staggered deadlines depending on the risk class of the device. Those deadlines could be 2027 for class III and class IIb devices (i.e. devices with a higher risk) and 2028 for class IIa and class I devices (i.e. lower risk devices) that need the involvement of a notified body in the conformity assessment;
⮚ if needed for legal and practical reasons (including for access to third country markets), the extension of the transitional period could be combined with an extension of the validity of certificates issued under Council Directives 90/385/EEC and 93/42/EEC by amending Article 120(2) MDR;
⮚ conditions to be fulfilled in order to ensure that the extension applies only to devices that do not present any unacceptable risk to health and safety, have not undergone significant changes in design or intended purpose and for which the manufacturers have already undertaken the necessary steps to launch the certification process under the MDR, such as adaptation of their quality management system to the MDR and submission and/or acceptance of the manufacturer’s application for conformity assessment by a notified body before a certain deadline (e.g. 26 May 2024);
⮚ the removal of the ‘sell off’ provision in Article 120(4) MDR and Article 110(4) IVDR
Change is never easy and without a doubt, this overhaul in legislation is a big change for all parties. Unfortunately, information is still quite unclear and changing. Updates are released quite often and everyone in the medical device industry will have to deal with it until the dust settles. With this latest proposal, the Council shows that the information from all stakeholders is heard and they are trying to help overcome the hurdles. That's a good sign and it will help manufacturers adjust to the MDR, however, it might come too late for some.
One thought that should remain central in all of this is the patient well-being. All parties should have as top priority to make sure patients remain to have access to all categories of medical devices.