The clinical evaluation of medical devices in view of Regulation EU 745/2017: are we ready?
The date of application of Regulation EU 745/2017 (hereafter MDR, 26 May 2020) is close and Medical Device (MD) manufacturers shall be prepared to meet the new requirements.
For all MD classes the evidence of the conformity must also include a “clinical evaluation”. This was already provide for by Directive 93/42/EEC, however the new regulation defines specific requirements and clarifies aspects that the directive left to the manufacturer’s discretion or described in the guidelines, in any case not legally binding, and published on a later stage when required.
Regulators have chosen to include in the MDR much more detailed information regarding the different aspects and the clinical evaluation is no exception: the term “clinical evaluation” is mentioned 123 times.
Article 61 defines the requirements for the performance of the clinical evaluation of a medical device, and further clarifications are reported in Annex XIV, part A, on how to perform a clinical evaluation, that should be the result of a programmed process carried out on a continuous basis.
Many concepts reported in this annex were actually already present in the MEDDEV 2.7/1; however now, as integral part of the MDR text, they become legally binding requirements for the manufacturers.
It should be also added that the MDR provides for the obligation to carry out another activity, that is the post-marketing clinical Follow-up (PMCF). This should also be a continuous process that, based on the clinical data collected by the manufacturer on the use of MDs already on the market, provides inputs to update the clinical evaluation itself, among other documentation.
Although the Regulation dedicates wide sections to the clinical evaluation, many essential aspects for its performance still remain unclear.
This is showed by the fact that some guidelines from the MDCG subgroup dedicated by the European Commission to clinical investigations and evaluation are still missing. These will concern:
- The concept of “Equivalence” in the clinical evaluation;
- The clinical evidence required for previously certified medical devices in compliance with directives 93/42/EEC and 90/385/EEC (cd. Legacy devices);
- The template for the clinical evaluation analysis report.
Although the date of application of Regulation EU 745/2017 is very close, there are still many doubts on how the manufacturers shall comply with its requirements.
The clinical evaluation is no exception: this could undergo sensible changes, although it has been widely discussed and evolved with the directive.
So far, however, it is difficult to define which is an example of clinical evaluation of a medical device, without the support of the guidelines that the European Commission must still draft.
Written by: Daniele Scarpino
Foto di Julio César Velásquez Mejía da Pixabay
