EU MDR is in Full Swing. Here’s What You Should Know

After a one-year delay due to the pandemic, the European Medicines Agency finally put the European Medical Devices Regulation 2017/745 (EU MDR) in effect. Here are the basics.

• The EU MDR is a regulatory framework for medical devices produced in or supplied to Europe.
• It replaces the Medical Device Directive (MDD), the Active Implantable Medical Devices (AIMD), and the In-vitro Diagnostic Directive (IVDD).?
• This new framework usher in significant changes in how medical device manufacturers obtain CE Marking and maintain access to the European market.?

So, what are the critical changes in the updated EU MDR regulations? Here are a few highlights:

• Enforces stricter rules for monitoring and reporting adverse events related to medical devices. Manufacturers will be required to maintain a vigilance system and report any incidents to the relevant authorities.
• More stringent clinical evaluation requires manufacturers to provide more detailed information about the safety and performance of their products.
• New classification rules for medical devices will impact the level of oversight and testing required for each product.
• Changes in post-market surveillance control that require manufacturers to actively collect and report data on the performance of their products over time.

What is EU MDR’s impact on clinical data collection?

These changes are designed to ensure that medical devices on the EU market are safe and effective for patients. However, they also represent a significant challenge for medical device companies, which will need to invest time and resources into meeting the new requirements.?

Many devices may be reclassified to a higher device class, triggering a higher clinical data requirement. EU MDR also allows legislators to impose high fines on companies that do not meet the specified standards. The result? Manufacturers are scrambling to comply with these new requirements.

EU MDR applies to any manufacturer producing or supplying medical devices to Europe. It brings significant regulatory change, including:

• Requiring the re-classification and re-registration of all medical devices currently on the market.
• Outlining new clinical data requirements for (maintaining) certification of medical devices.
• Requiring more clinical data collection throughout the product’s life cycle.
• Raising the bar for the level of required evidence.

To comply with EU MDR and its focus on real-world clinical evidence, companies must generate more documentation for health authorities and conduct new clinical studies. Of course, this impact costs, processes, outsourcing, and other business functions.

If you are looking to stay compliant and build a successful regulatory strategy for your medical device trials, it is important to adapt to potential changes. Start now by reading our whitepaper on data collection under the EU MDR - it offers a detailed overview of the updated regulations and practical advice about compliance.