Medical Devices Regulation – a brief overview
On 5 May 2017, the new Medical Devices Regulation came into force (now with a transitional phase until 25.05.2021). From 26.05.2021, the new Medical Device Regulation EU 2017/745 (MDR=Medical Device Regulation) will apply. It applies to all medical devices in the various risk classes. The regulation affects approximately 500,000 medical devices in Europe. This enormous scope and diversity require a comprehensive set of rules and also transitional periods. The importance for all areas (including certification) is already evident from its 175 pages in the Official Journal of the EU. Understandably, this places enormous demands on the capacity of the notified bodies. Users can therefore expect that a number of manufacturers will carry out portfolio adjustments due to the enormous requirements.
Why is there a new Medical Devices Regulation?
With this regulation, the EU wants to improve the quality of medical devices. The goals are to improve safety (patient safety), improve transparency and traceability, and improve the identification of medical devices over their entire service life or service life. For this reason, the "old" Regulation 93/42 EEC of 1993 was replaced by the new Regulation.
The scope of the new Medical Devices Regulation
The new European Medical Devices Regulation (MDR for short) regulates the placing of medical devices on the market throughout Europe and sets out the requirements for the conformity assessment of medical devices. The regulation applies to all manufacturers of medical devices who want to place their products on the market in the EU. From its introduction, the MDR is considered European, supranational law (national additions to the requirements in the individual EU countries are possible). This means that the same product standards apply in all European countries. The aim is to improve safety, traceability and transparency in all EU countries. The system makes it possible to set a product identification number UDI (Unique Device Information), similar to what happens with pharmaceuticals (through the PPN: Pharmacy Product Number). The International Medical Device Regulators Forum (IMDRF) is responsible for this. The EU is a member of the IMDRF. The new MDR introduces the term "economic actor". According to the MDR, this is a manufacturer, an authorized representative, an importer, a distributor and distributor of systems and treatment units.
What is the role of economic actors?
A manufacturer manufactures a product under his own brand or name, an importer is a natural or legal person established in the Union who places a product from a third country on the EU market. The next economic actor is the retailer. All economic actors have defined responsibilities and obligations, with traceability playing an essential role. Before the product is placed on the market, the distributor checks whether the product bears the CE marking and whether an EU declaration of conformity has been issued, whether the product is marked in accordance with the MDR in the applicable national language, whether the importer has affixed his name and contact address to the product or an accompanying document, and whether the manufacturer has issued a UDI for the product (if applicable). If there is a suspicion that a product does not comply with the Regulation, the distributor is not allowed to make the product available on the market and informs the other economic operators. In the event of serious danger or suspicion of forgery, the local authority must also be informed. The dealer cooperates with the authorities. If necessary, a user must contact the dealer or consult the MDR or UDI databases.
What are the main changes resulting from the MDR?
The new EU Medical Device Regulation (MDR) will replace the previous Medical Device Directives, namely the two Directives:
- 93/42/EEC on Medical Device Directives (MDD) and
- 90/385/EEC on Active Implantable Medical Devices (AIMD)
All certified medical devices and active implantable medical devices, without exception, must be recertified in compliance with the new regulations. To increase security, the UDI and EUDAMED databases (as soon as they are fully operational) will be used; these provide greater transparency for logistics and market surveillance as well as post-market surveillance (PMS = Post Market Surveillance); shortened reporting deadlines for incidents are applied in the MDR. The manufacturer first classifies its products into different risk classes.
This classification determines which conformity assessment procedure is used. A distinction is made between low-risk medical devices (class I) and high-risk devices (class III). Currently, medical devices for protective purposes are still in high demand (keyword Corona), especially mouth and nose protection, examination gloves and medical protective clothing. These mainly fall into risk class I.
The European standard EN 455 continues to serve as a guideline for testing single-use medical gloves for e.g. quality, physical properties, glove dimensions, tear resistance, resistance to biological hazards and durability. Surgical gloves fall into Class IIa and must be certified by an independent certification institute.