by Laura C Collada Ali – Medical Writing & Scientific Manager, MedDev Day Scientific Coordinator at LS Academy
The growing prevalence of chronic diseases, and the increasing emphasis of healthcare agencies towards early diagnosis and treatment, is leading to an increasing number of patients undergoing diagnostic and surgical procedures, even more at risk with the rise in the number of inpatient admissions. All these parameters are fueling the demand for medical devices, including capital equipment and consumables in developed and emerging countries.
Fortune Business Insights estimate that the global medical devices market size was USD 432.23 billion in 2020. The market is projected to grow from of more than 20% from 2021 to 2028. The sudden rise in this Compound Annual Growth Rate (CAGR) is attributable to this market’s demand and growth, returning to pre-pandemic levels.
The publication of the MDR 2017/45 an IVDR 2017/46 was a milestone in the Medical Devices revolution. It represented the most radical shift in EU regulation of medical devices for decades; replacing existing EU legislation dating back to the ‘90s. Still, the world of medical devices is now facing the actual capacity of Notified Bodies (NB) to address all incoming requests to issue MDR/IVDR certificates.
Team Notified Body has recently published the results of their 2021 survey towards its members on certificates, capacity, etc. Since 2010, all Team-NB members contribute to this survey. This allows them to provide data on the sector over the past year and to identify trends by comparison with data from previous years. The 2021 survey compiled data from 30 notified bodies, the total number of Team-NB members at the end of 2021.
Among interesting data, we see that:
- Lead times of issuance of certificates are over 1 year in more than 50% of instances.
- 75% of NBs indicate that at least half of the technical dossier submitted are deemed incomplete, and request additional information to start the assessment.
- The transition process is rather slow considering the deadline approaching in 2024. If manufacturers holding directive certificates wish to continue to place products on the market, numerous QMS (Quality Management System) and Technical Documentation reviews need to be completed. Even applications are low considering that there are only two years remaining.
- With average capacity (under MDD) of issuance of around 6,300 certificates per year, the number of certificates expiring in 2024 of over 13,000 will cause problems to all; manufacturers, patients, and the healthcare system. There is a real risk to the continuous availability of some device with expiring certificates in 2024. To avoid this risk, solutions have to be found as it will not be feasible to issue an appropriate number of certificates in a year.
Among the common problems the medical devices sector is facing, we see the difficulty in hiring resources with the required competence as everyone is fishing from the same pool (manufacturers, notified bodies, consultants and authorities); the bureaucracy connected with both EU MDR and EU IVDR is high and is killing a lot of capacity also on both sides (manufacturers and NBs); the EU IVDR presents even bigger challenges as compared to the EU MDR, but manufacturers may not be aware yet and delaying the legislation will not be of help unless we first get a sustainable solution.
Also, fresh from the International Clinical Trials Day (celebrated on the 20th May), we do not need to forget that the MDR and the IVDR contain autonomous regimes for clinical trials with devices and IVDs, clinical investigations and performance studies respectively.
Finally, considering the practical impact of all these factors, given that capacity issues in the system are a concern, planning around relevant support is critical for manufacturers to carry out due analysis of how they sit with their current portfolio of products or the ones coming to market soon.