How are medical device trials classified and submitted?
Under the European Medical Devices Regulation (EU) 2017/745 (MDR), there are different frameworks for medical device clinical trials.
How are pre-approval studies (Art. 62) submitted?
Medical device clinical trials demonstrating safety and/or performance to support their conformity assessment, fall within Article 62 of the EU MDR regulation. Their regulatory pathways can differ depending on the medical device risk classification. Medical device clinical trials for low-risk devices (class I and non-invasive class IIa and IIb) can start after validation, subject to national provisions and a positive ethics opinion. The validation process can take at least 10 days but up to 25 days with queries. In rare circumstances, the process can take up to 55 days if all the relevant extensions are applied.
Medical device clinical trials for highrisk devices (invasive class IIa, invasive class IIb, and class III) can only start after a full assessment of the application and receipt of a positive ethics opinion. After the validation process described above, there is an additional assessment period. This can take between 45-65 days, excluding any postponement caused by a ‘clock stop’ during a query response.
How are post-market clinical follow-ups (PMCFs) submitted?
Under Article 74 (1), post-market clinical follow-up (PMCF) studies which include procedures additional and burdensome to those performed under normal conditions of use of the device are subject to a 30-day notification procedure. The requirements of PMCFs are similar to pre-approval studies (i.e. documentation, substantial modifications, legal representation and informed consent).
What about EUDAMED?
A EUropean DAtabase on MEdical Devices (EUDAMED) is in the process of development in accordance with Article 73. This will be an online database where sponsors will submit applications for clinical investigations, in addition to other product lifecycle stages.
However, the relevant clinical investigation EUDAMED module is not scheduled to become mandatory until Q4 2027. Until then, clinical investigation applications must be made at a national level. Individual countries may have different submission procedures, therefore, thorough research and planning at a national level is required – particularly for multi-national studies.
What else must be considered?
Documentation requirements for clinical investigation submissions are outlined in Chapter II, Annex XV of the EU MDR and are similar for pre-approval and PMCF studies. However, national requirements may stipulate further documentation (e.g. risk management, insurance). Similarly, once the study is ongoing there may be national requirements (e.g. urgent safety measures, annual reporting) which are not discussed in the MDR.
Sponsors must also consider if there are other applicable regulatory frameworks to their study. For example, combination products (i.e. drug-device) may fall within the Clinical Trials Regulation (EU) 536/2014 – depending on the product design and primary mode of action. Furthermore, use of radiation and/or radioactive substances in some countries requires additional documentation and/ or submissions (e.g. Germany, UK, and Ireland).
How can Lumis Consulting help?
Lumis Life Science Consulting supports medical device companies by providing solutions in regulatory affairs and clinical trial processes and oversight. We understand the complexities of the MDR and have a team of experienced professionals with deep industry expertise. Therefore, Lumis is well-positioned to provide regulatory services throughout medical device development.
