Medical Device Regulation – a brief overview
On May 5, 2017, the new Medical Device Regulation came into force (now with a transition period until May 25, 2021). From May 26, 2021, the new Medical Device Regulation EU 2017/745 (MDR) will apply. It applies to all medical devices of different risk classes. The regulation affects approximately 500,000 medical devices in Europe. This enormous scope and diversity necessitate a comprehensive set of rules and also transition periods. The significance for all areas (including certification) is evident from its sheer volume of 175 pages in the EU Official Journal. This understandably places enormous demands on the capacity of the notified bodies. Users can therefore expect that due to the enormous requirements, several manufacturers will carry out portfolio adjustments.
Why is there a new Medical Device Regulation?
With this regulation, the EU aims to improve the quality of medical devices. The goals are an improvement in safety (patient safety), an improvement in transparency and traceability, and improved identification of medical devices throughout their entire period of use or lifespan. For this reason, the "old" Directive 93/42 EEC of 1993 was replaced by the new regulation.
The scope of the new Medical Device Regulation
The new European Medical Device Regulation (MDR for short) governs the placing on the market of medical devices throughout Europe and defines the requirements for the conformity assessment of medical devices. The regulation applies to all manufacturers of medical devices who wish to market their products in the EU. The MDR applies from its introduction as European, supranational law (national additions to the requirements in individual EU countries are possible). This means that the same product standards apply in all European countries. In this way, safety, traceability, and transparency are to be improved in all EU countries. The system makes it possible to establish a UDI (Unique Device Identification) product identification number, similar to what happens with medicines (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 operator". According to the MDR, this is a manufacturer, an authorized representative, an importer, a distributor, and a person who places systems and procedure packs on the market.
What role do economic operators play?
A manufacturer produces a product under its 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 operator is the distributor. Defined responsibilities and obligations are associated with all economic operators, with traceability playing a key role. Before the product enters trade, the distributor checks whether the product bears the CE marking and whether an EU declaration of conformity has been issued, whether the product is labelled in the applicable national language according to the MDR, furthermore, whether the importer has affixed their name and contact address to the product or an accompanying document, and whether the manufacturer has assigned a UDI for the product (if applicable). If there is a suspicion that a product does not comply with the regulation, the distributor must not make the product available on the market and must inform the other economic operators. In case of serious danger or suspected counterfeiting, the local authority must also be informed. The distributor cooperates with the authorities. If necessary, a user must contact the distributor or consult the MDR or UDI databases.
What are the significant changes resulting from the MDR?
The new EU regulation on medical devices (Medical Device Regulation, MDR) will replace the previous medical device directives, namely the two directives:
- 93/42/EEC on Medical Devices (Medical Device Directive, MDD) and
- 90/385/EEC on active implantable medical devices (AIMD)
All certified medical devices and active implantable medical devices must be recertified without exception in compliance with the new regulations. To increase safety, the UDI and EUDAMED databases (once fully functional) will be used; these ensure greater transparency for logistics and market surveillance as well as post-market surveillance (PMS); shortened reporting deadlines for incidents will be applied in the MDR. The manufacturer will initially classify their products into different risk classes.
This classification determines which conformity assessment procedure is applied. A distinction is made between medical devices of low risk (Class I) and products with high risk (Class III). Currently, medical devices for protective purposes are still in high demand (keyword Corona), especially mouth-nose protection, examination gloves and medical protective clothing. These predominantly fall into risk class I.
The European standard EN 455, as before, serves as a guide for testing single-use medical gloves for, e.g., quality, physical properties, glove dimensions, tensile strength, resistance to biological hazards, and durability. Surgical gloves fall into class IIa and must be certified by an independent certification body.
