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).
One year later, from May 26, 2022, the scope of the new MDR will be extended to include in-vitro diagnostics. From May 27, 2024 onwards, MDD/AIMDD certificates will also lose their validity.
Innovations by MDR 2017/745
Manufacturers of medical devices are subject to a number of new requirements as a result of the EU Medical Device Directive, mainly the following:
- The scope of application also extends to non-medical products (e.g. contact lenses, devices for liposuction).
- Each medical device must bear a unique identification number (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, especially in connection with the required risk management.
- Clinical trials and evaluations are being tightened and products are being monitored even after their market launch.
- Responsible persons who have qualified expertise on the manufacturing of medical devices must be appointed.
- For high-risk medical devices, an additional control procedure (called ‘scrutiny procedure’) for conformity assessment by a panel of experts is planned.
- Notified bodies are more strictly regulated, so that a renewed selection and inspection may be necessary.
Unique Device Identification (UDI)
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.
A 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.
Weber is your partner in medical device labeling!
Medical devices must be traceable. This is only possible with appropriate labeling systems, which allow the products to be clearly identified. This also helps with internal quality assurance and process safety. We have the right solutions in the area of labeling and inkjet printing. Please feel free to contact our team of experts with any questions or sampling requests – simply use our contact form!