Medical Device Labeling: EU Regulation MDR 2017/745

So far, three European directives regulated the requirements for the marketing of medical devices in the European Economic Area:

• Council Directive 90/385/EEC for active implantable medical devices
• Council Directive 93/42/EEC for medical products
• Directive 98/79/EC for in vitro diagnostic

The national implementation of these directives is also known in Germany and Austria as the Medizinproduktegesetz (MPG).

Medical devices are devices, objects, substances and software that are used for therapeutic or diagnostic purposes for human beings. They differ in their physical mode of action from drugs (pharmacological, metabolic or immunological mode of action), which in turn are subject to their own regulations.

In order to meet the constantly evolving requirements for medical devices, the European Parliament and the European Council issued the new European Medical Device Regulation EU 2017/745 on April 5, 2017. The directive is also known as the Medical Device Regulation (MDR).

Originally, a three-year transition period applied to the implementation of the new EU Medical Devices Regulation 2017/745. Accordingly, the essential provisions were to be fully implemented by May 26, 2020. Due to the COVID-19 pandemic, the effective date was postponed by one year. Thus, the new effective date was May 26, 2021.

One year later, as of May 26, 2022, the scope of the new MDR was also extended to in vitro diagnostic medical devices. On May 27, 2024, MDD/AIMDD certificates also lost their validity.

The EU Medical Device Regulation imposes several new requirements on medical device manufacturers, primarily the following:

• The scope of application has been expanded to include non-medical devices, such as contact lenses or liposuction devices.
• Every medical device must bear a unique device identifier (UDI).
• Manufacturers must register themselves and their products via the Europe-wide EUDAMED database and submit their data.
• Higher requirements are placed on technical documentation, particularly in connection with the required risk management.
• Clinical trials and evaluations are being tightened, and products will also be monitored after market launch.
• Responsible persons must be designated who possess qualified expertise in medical devices.
• For high-risk medical devices, an additional review procedure for conformity assessment by a panel of experts is provided for (the so-called scrutiny procedure).
• Notified bodies are subject to stricter regulations, which may necessitate a new selection and review process.

The new MDR also includes new requirements for unique product identification numbers. With the Unique Device Identification (UDI), a worldwide system for a uniform product marking for medical devices was introduced. The marking must be applied on the product as well as on all higher packaging levels. It is intended to enable the unique identification and traceability of products, as well as to facilitate safety-relevant measures and combat product counterfeiting.

An UDI consists of three building blocks:

• The Device Identifier (DI), a static code for article identification.
• The Production Identifier (PI), a code that ensures traceability such as a batch number, a serial number or an expiry date.
• The Basic UDI-DI (DI), the model number of the medical device group.

The regulation stipulates that the Device Identifier (DI) and the Production Identifier (PI) must be applied to each product or packaging unit, both in plain text and encrypted in a machine-readable barcode, data matrix code or RFID chip.