Impact of EU Medical Device Regulation on Class I Medical Devices
In 2017, the European Commission released a new revision of its renowned EU Medical Device Regulation, or MEDDEV Rev4.
This revision, number four, leads to a massive change for medical device manufacturer that will need to respect this new Regulation by spring 2020 for all Medical Devices, while in-vitro diagnostics companies (IVD) get a respite of 2 more years (therefore spring 2022). This new iteration is leading to changes in the CE marking process. In addition, the closure of activities of certain notified bodies is having a massive impact on the manufacturer’s deadline for release to market, especially when these notified bodies are necessary (Class 2b, Class III).
On the other hand, the class I medical devices, for which the process for CE marking is generally simple, have also been significantly impacted by the regulatory aspect. Note that some of the below requirements are also applicable to other classes of devices.
While the manufacturer can still self-certify (CE mark) their product, there are certain requirements that need to be met, specifically regarding the Clinical Evaluation Report (CER). This document is significant not only for the EU but also Australia and China, although the latter has its own requirements.
- Clinical data and scientific acumen: While comprehensive published data may still work, these data need to be scientifically validated, and statistically significant. The manufacturer needs to verify if they have enough clinical evidence for their claims, or if they need to go ahead with clinical trials.
- State of the art: while this was requested in the past, the new MEDDEV rev 4 provides more details on what is to be found in the CER.
- Risk / benefit assessment: the MEDDEV provides more details on what the CER writer and evaluator are expected to put in the document.
- Evaluation criteria: The CER needs to clearly define the objectives, in terms of security, risk and performance.
- Authors and evaluators: Section 6.4 pushes the manufacturer to ensure that the authors and evaluators of the CER are experts or have enough experience (5 or 10 years of experience, according to the relevant higher education degree he or she would have). All Evaluators must make a declaration of interest, a document that is roughly a disclosure of financial interest.
- The equivalency route is restricted for all type of devices. This has to be done against one device in particular (the one the most similar to the new device). The equivalent device must have the same purpose (intention of use and materials) as the new device.
- The CER is still meant to be updated annually for devices with high risks or innovative, and every two to five for low risks devices.
- Post-market studies, data and surveillance are pushed further to ensure the manufacturer’s responsibilities throughout the lifecycle of the CE marked device. While the surveillance and the collection of the data is required for all classes, the post-market studies are mandatory only for class III.
Although the repercussion of the new MEDDEV is expected to be felt in 2020, most manufacturers are already getting themselves ready and updating their CER according to revision 4 or getting more post-market data. This will lead to more secure devices for the patients and a clearer path to follow for the manufacturers.
Author: Waza Hadjebi, Centaur Clinical.
Waza is the CEO of Centaur Clinical, a CRO that focuses on clinical and pre-clinical operations for medical devices in Europe and across the globe. Centaur has helped various manufacturers for their post-market studies, preclinical studies, and for their CE marking and reimbursement.