If you are planning to market a medical device in the EU (European Union), it’s important to understand the MDR (Medical Device Regulation).

Last year, substantial changes to Medical Device Regulations (MDR) were approved by the European Council to take full effect in mid 2020. The new MDR combines the requirements of Medical Device Directive (MDD) and the Active Implantable Medical Device Direction (AIMD), and is in direct response to the technical and scientific developments that are quickly shaping the medical device industry.

Overall, the new regulations seek to increase medical device safety and effectiveness in the EU Market while addressing new technology that is absent from the Medical Device Directive (MDD). The regulation expands the requirements for Product Classification, Own Brand Labeling, Regulatory Submission Evidence, and Post-Market Surveillance. There will be additional changes for distributors, importers and labeling. These changes may impact your existing products or any products under development.

This article provides a quick summary of the key changes, aiding medical device developers and medtech organizations in their plans to transition to the new regulations.

The “medical device” classification will expand to new areas and include devices that may not have an intended medical use.

Medical device classification in the EU is determined by applying Classification Rules defined in the regulation for each product; this is different than the FDA approach of classifying products into categories (Class I, II, or III).  

New areas that will be classified as a medical device include:

• Aesthetic products - colored contact lenses, cosmetic implants, lipoplasty devices, and laser products used for hair removal.

• Cleaning products – anything used for cleaning, disinfecting, and sterilizing medical devices (e.g., scope disinfector).

• Conception products (for support or control) – condom, intrauterine device.

Note: devices previously cleared under the MDD/AIMD can’t be sold on the EU market after May 27, 2025. For these devices, manufacturers must review updated classification rules and modify their technical documentation to meet more stringent requirements. 

Companies that have Own Brand Label or Private Label products (those that are manufactured by one company and sold under the brand of another) now will be responsible for providing a full technical file of that product.

Under the previous directive, there was a difference in the obligations between an OEM (Original Equipment Manufacturer) and an OBL (Own Brand Labeling Manufacturer). While the OEM was responsible for the full technical file, the OBL was only responsible for an abbreviated technical file. In the new regulation this differentiation has been removed, so there is no longer an exception for OBLs. 

This is consistent with other trends from other regulatory bodies. In 2017 the MHRA (British Medicines and Healthcare Product Regulatory Agency) referred to this practice as “Virtual Manufacturing” instead of “Own Brand Labeling”.

Increased expectations for regulatory submission evidence, including clinical evidence related to safety, are higher under the MDR.  

New Regulatory submissions will have a higher emphasis on safety and rigor, starting with resources. There is a new requirement to have at least one person possessing the necessary expertise who is responsible for regulatory compliance to be available continuously.

The technical documents required now align with the Global Harmonization Task Force (GHTF) recommendations. Minimum requirements and structure for technical documentation is defined in the MDR, and a rationale must be provided for any exceptions.

For class III and implantable devices, such as heart valves and pacemakers, clinical investigations are required if there isn’t sufficient evidence for both safety and performance claims.  

For Class IIa and Class IIb devices, the bar is higher to justify not doing a new clinical study than in the previous directive. Class IIa medical devices include hearing aids, catheters, and electronic thermometers. Class IIb medical devices include infusion pumps.

Even if a new clinical study is not required, a strong rationale to support this may be required.

Manufacturers need to have a Post Market Surveillance Report (PMRS) and Periodic Safety Update Report (PSUR) in addition to a Post Market Surveillance plan.

Under the new MDR, manufacturers are expected to actively gather information (risk analysis, clinical evaluation) and update the product’s technical documentation with their findings. They will also be responsible for informing users about their risk findings.  

Since this change applies to devices already on the market, getting a plan in place and starting to collect the data required for Post Market Surveillance now is highly recommended.  

Prioritize Your Risk

This is a high-level overview of some of the key changes under the new regulation to help medical device developers and manufacturers prepare for the road ahead. Other sources for more detailed information (and interpretation) include the regulations themselves, published articles, and white papers from Notified Bodies (NB) and other suppliers.

To implement the new regulation, product developers, owners and manufacturers should seek to gain a greater understanding of the changing requirements and their impact on the product lines, as well as gather, prioritize and assess risk.