On May 26, 2020 the Regulation (EU) 2017/745 on Medical Devices (MDR) will enter into force in all member states of the EU simultaneously. This increases the importance of clinical data and also the requirements for documentation and risk monitoring change significantly.
In general, the clinical evaluation of medical devices and the associated way in which clinical data is generated will become more important. The aim is to show that the medical device provides the announced performance, is safe and can provide proof of the positive benefit-risk ratio. The way to prove the performance and safety of the medical device is described and justified in the clinical evaluation.
In addition, Notified Bodies will need to be MDR certified in the future. As there is currently only one MDR certified office in Europe, which (to make things even more difficult) is located in the UK (BSI UK), the availability of certified Notified Bodies may represent a huge challenge after May 2020.
Some manufacturers of medical devices of risk class I are particularly affected because their products may be assigned to a higher class (risk class IIa) after the conversion to MDR. In particular, from 26 May 2020, medical devices such as physical lozenges, dermatics or nasal sprays require MDR certification (with the involvement of a Notified Body). In addition, a quality management system according to ISO 13485 will be required.
Until the MDR enters into force, the transitional arrangement that has been in place since May 2017 applies. Until then, clinical data can be generated according to the current Medical Device Directive (Council Directive 93/42 / EEC; MDD). However, some Notified Bodies have stated that they will stop conducting re-certifications according to MDD as early as autumn 2019.
In view of the above mentioned facts one thing is certain: through MDR the certification / recertification of a medical device requires a lot more effort. The limited availability of MDR-certified Notified Bodies (“bottleneck”) appears to be risky. In order to avoid this risk, it is advisable to collect clinical data in accordance with current guidelines before MDR is a practical fact, thus extending the transitional period by a further 4 years. It should be noted that no changes are to be made to the medical device whithin the extended four-year period.
We have formed an alliance with the company ‘Pro-Liance’ to provide medical device manufacturers with a complete and competent service in dealing with the requirements of the Medical Devices Directive. Our partner Pro-Liance carries out an analysis of the available data on the medical device (gap analysis), thus identifying possible shortcomings in the clinical data. The Gap Analysis allows informed planning of the next steps to complete the data with the focus on approval. Pro-Liance will also analyze if a clinical trial is required to complete the clinical assessment, if necessary.
For the planning, implementation and evaluation of clinical trials (including post-market clinical follow-up studies = PMCF), proDERM is your competent partner. Depending on your needs, we carry out these studies both in a single-center and multi-center way, where external testing centers such as medical practices, hospitals and university hospitals would be included.
Our recommendation: take advantage of the possibility to collect clinical data on PMCF studies in 2019 before MDR is implemented. This would enable you to extend the CE certification of your product. In addition, these studies are not subject to approval when compliance with the requirements of § 23b MPG is given.