The European Union (EU) Medical Device Regulation (MDR) 2017/745 came into force in May 2021.\(^1\) The EU MDR currently regulates the clinical investigation and commercial landscape of medical devices in Europe. This regulation change impacts clinical trial sponsors that are based in the EU and those that are based elsewhere but plan to conduct trials in the EU. Therefore, clinical trial sponsors both within Europe and outside of Europe are impacted by this change in regulations.
With a goal of making the EU medical device market more safe and efficient, the new EU MDR includes a number of changes. EU MDR 2017/745 expands the scope of medical device regulation in Europe to include devices not initially intended for medical purpose. This includes such devices as contact lenses, fillers injected subcutaneously, tattoo removal lasers, and liposuction equipment. Therefore, in addition to traditional medical device companies, some non-medical companies fall under the new regulation and are required to navigate these requirements.
One of the most significant EU MDR changes is the requirement for all medical devices to be assigned a unique device identification (UDI) code. The new regulation also introduces a UDI database called EUDAMED, created by the European Commission. All devices meeting Class III or Class IIa/b designation must have their UDI recorded, indexed, and registered in EUDAMED.\(^1\) Even though the EU MDR is already in force, EUDAMED is not yet fully functional, which means that until it is, local legislations are still valid as an interim solution. It is therefore critical for new and existing medical device companies to understand and prepare for the changes introduced by the new EU MDR regulation.
The EU MDR separates medical device clinical trials into three categories. First is trials for the assessment of conformity (per Article 62), which are now subject to approval. Second is trials for post-market clinical follow-up (PMCF) investigation (per Article 74), which are now subject to notification but not approval. And third is all other medical device clinical trials (per Article 82) which are not subject to approval or notification.
Medical device clinical trials are obligatory for all Class III and implantable devices. Therefore, most medical device companies will encounter these new designations for their upcoming clinical trials and must be prepared for the new requirements. The flowchart below was designed to assist sponsors and clinical research organizations (CRO) navigate the decision of whether to seek approval or notification.
The EU MDR changes some aspects of clinical trial submissions. One is that it permits trial sponsors to submit a single application when multiple member states will participate in the trial. In this way, it streamlines the application process for sponsors and reduces redundancies. These applications must be submitted through the new EUDAMED database, as will subsequent submissions throughout the clinical trial.
Following a clinical trial application submission, the Ethics Committee (EC) will review the application and issue a decision.\(^2\) This decision is based on national legislation in the member state of the EC, and therefore has variability based on which member state is involved. When multiple member states are involved, a coordinating member state is designated.
The EU MDR requires that medical device clinical trial design follow two main principles. First, the well-being of subjects is of high priority, and trials should be designed with minimal risks and minimal impairments. Second, trials should generate scientifically valid, reliable, and robust clinical data. Already there are best practice guidelines being published which can serve as a framework to help design clinical trials that adhere to EU MDR standards.\(^3\)
Then for clinical trial conduct, the EU MDR stipulates that the informed consent form (ICF) should not exceed a reasonable length, which facilitates better patient understanding. Furthermore, all serious adverse events (SAE) and device deficiencies (DD) must be recorded by the sponsor and reported in the EUDAMED database. The notification period for these reporting requirements depends on the severity of the event.\(^4\)
Dokumeds is a CRO based in Europe, with 25 years experience in the market. Among several areas of CRO services, Dokumeds has in-house expertise with medical services and regulatory affairs. Dokumeds has experienced and adapted to many regulatory changes over the years, and served as a partner to clinical trial sponsors on medical device trials. The clinical trials regulatory expertise of Dokumeds is an important asset to clinical trial sponsors, especially during this time of navigating new requirements.