The 2020 conference, or “convergence,” of European regulatory professionals that was originally to be held in October in Brussels instead took place virtually due to the pandemic. Even though it was conducted entirely online, the convergence covered a lot of regulatory ground.
Many of the presentations and talks centered around innovation and its growing importance in light of the current global pandemic, which has affected every industry in every corner of the world. Many of the participants touched upon how innovation has influenced a wide range of issues, processes, and tools – especially technology. The importance of big data and artificial intelligence cannot be overestimated as a growing number of organizations are using them to fill knowledge gaps and make informed data-driven decisions.
Specifically, innovation is driving significant changes in the evolution of clinical trials and the implementation of complex innovative design, master protocols, decentralized trials, real-world data and evidence, modeling, and novel stakeholder engagement. Product safety will be improved through applied data and predictive solutions.
Changes to clinical investigation under the new Medical Device Regulation (MDR)
Clinical investigations and evidence were the subjects of much discussion in anticipation of the changes coming in May. The EU MDR reinforces the rules on clinical evidence and requires manufacturers to implement robust post-market clinical data collection programs for their devices. The MDR also incorporates more rules on the design and conduct of studies and these are well aligned with good clinical practice (GCP). The biggest change affecting study execution is in the application process to the competent authorities through EUDAMED. The MDR will require implementation of relatively minor changes to study execution, a much higher volume of studies particularly post-market, and increased compliance to GCP.
Evolving regulations to affect drug/device combination products
European regulators are preparing to implement new requirements for drug/device combination products under the new MDR that takes full effect in May 2021, and both manufacturers and notified bodies are struggling with how to address some yet-to-be-resolved issues. What is clear, though, is that these combination products will face new regulatory hurdles.
There are three main categories of combo products that will be affected by the new MDR:
Devices to administer medicines MDR requirements for co-packaged devices include General Safety and Performance Requirements (GSPR) 10.3, which is similar to requirements under the Medical Devices Directive (MDD). However, the wording has been changed to clarify that a medical device cannot be used with a licensed medicine in an off-label fashion. Labeling, for now, remains a sticky issue for co-packaged products, presenting a challenge to manufacturers who must comply with labeling requirements for both device and medicinal products.
Ancillary devices These devices, whose action is primarily physical but also contain an ancillary medicine (such as a drug-eluting stent), are regulated as devices under Rule 14 of the MDR. However, the usefulness of the ancillary medicine must be assessed and that assessment may be affected by the removal of the phrase “liability to act” from Rule 14, bringing into question whether Rule 13 applies to the specific product. Manufacturers falling into this grey area will need to go through an arbitration process with the Competent Authority and the MDCG over classification. Clarification is needed on this issue from the European Commission.
Integral devices These devices’ main purpose is to deliver medicine, but the medicine and the device form a single integral product, such as a pre-filled syringe or inhaler. These devices are regulated as a medicine but the device must also show conformity under MDR Article 117. To be marketed, devices should either have a CE certificate, a declaration of conformity, or a notified body opinion on the relevant safety and performance requirements.
There is no question that the European medical device market will undergo many changes in 2021 with the full implementation of MDR. If entering the market or expanding your presence in Europe are part of your 2021 plans, contact us today to learn more about how we can help you successfully navigate the evolving regulatory landscape of the European Union.
MEDIcept … Trusted Solutions, Rapid Response …
MEDIcept Inc. is an international consulting firm specializing in medical device, IVD, and biotechnology Regulatory, Quality, and Clinical Services. Since 1996, we have worked with thousands of companies to solve their most critical FDA and ISO issues. Our integrated solutions are rooted in our direct experience and span all stages of the product life.
Our staff includes former FDA and ISO personnel and industry experts with an in-depth functional knowledge of medical devices. Medical device compliance requires the navigation of a maze of requirements. MEDIcept can interpret FDA regulations, guidance documents, and ISO standards and provide clients with the information they need to comply in a safe and cost-effective manner.
MEDIcept is committed to providing our clients with what they need. We are committed to quality deliverables because we value our clients’ time and resources. This is why 90% of our clients come back to us again and again to solve new issues.
For additional information, please contact Susan Reilly at SReilly@MEDIcept.com.