EU MDR Replaces Medical Devices Directive, Prompting More Stringent Requirements for Medical Device Companies

EU MDR Replaces Medical Devices Directive, Prompting More Stringent Requirements for Medical Device Companies

The European Union (EU) Medical Device Regulation (MDR) EU 2017/745 replaced the Medical Devices Directive (MDD) on May 25, 2017, with the aim of improving clinical safety and supporting fair market access for manufacturers.

The EU MDR builds upon the MDD by expanding the scope of products covered, including cosmetic medical devices such as colored contact lenses without vision correction, lasers for cosmetic skin treatments and equipment for liposuction. It also adds new requirements for medical devices. Dividing products by risk level, manufacturers are required to follow a specific process before entering the European market. Encouraging a proactive approach to compliance and quality management, one of the EU MDR’s first requirements is the development of an internal quality management system (QMS). Depending on risk level, manufacturers may be audited on the QMS in place.

Additional requirements focus on the products themselves. The EU MDR requires the development of a technical file based on the EU MDR substance list, necessitating clear lines of communication with suppliers. This technical file includes a long list of information, such as:

  • The substances used in the product.
  • A risk profile of each substance.
  • An outline of potential exposure scenarios.
  • An assessment of alternative substances
  • A justification for the use of each substance.

Once the completed technical file has been reviewed and approved by a notified body, the manufacturer must compile a Declaration of Conformity. The manufacturer must then acquire an EU unique device identifier (UDI) and enter the product into the European Database on Medical Devices (EUDAMED).

Learn more about the EU MDR by downloading our eBook, Understanding the EU Medical Device Regulation.

It is important to note that the EU MDR was developed in tandem with the In-Vitro Medical Device Regulation (IVDR) 2017/746, which specifically covers in-vitro medical devices and excludes medical devices where the integral part of the product is covered under the EU MDR. The IVDR covers a wider scope of substances, and requires that substances are reported at trace levels.

The transition period for the EU MDR will continue into the spring of 2020, with legacy products being approved under the MDD and the Active Implantable Medical Devices (AIMD) regulation until 2024. The EU MDR date of application is May 25, 2020; from this date, product approvals must be made following the new EU MDR process.

With only a year until the deadline, companies must be proactive about meeting their requirements under the EU MDR to avoid disruptions in business continuity. Establishing a strong QMS is the first step toward compliance, and this involves collecting data, including accurate bills of materials that cover part numbers and manufacturer data. It is also important to prepare supplier training around the transition from the MDD to the EU MDR, and allocate adequate time to collect supplier data.

The Assent Compliance Platform allows companies to efficiently collect, manage and analyze data from across their supply chains. Our Chemical Reporting Module, part of the platform, enables efficient and accurate EU MDR data collection and management, which is vital to successful product certification.

To learn more about how Assent can help you stay compliant with the EU MDR, contact us at