Do you remember the high-profile case of defective breast implants of 2010? At the time, it was revealed that a French company was using industrial silicone without the appropriate medical approvals to manufacture its breast implants. The implants were more prone to rupture and the gel used in them caused inflammation and scarring, as well as other long-term side effects. They were implanted in at least 300,000 women worldwide, and the exact number was impossible to determine. The scandal revealed enormous difficulties with product traceability. It was hard to trace the product from the manufacturer to the patients, so many women underwent preventive surgery to remove the harmful implants. The company ceased to exist in 2010 and its executives were convicted – a total of 7,113 women filed lawsuits at the time. Following these events, the European Parliament announced work on a new system for regulating medical devices, which we now call Medical Device Regulation.
Even stricter law governing medical devices in the EU
The affair has prompted the European Parliament to reflect deeply on the law governing medical devices in the EU. Previous regulations were somewhat outdated and originated in the 1990s. The result of the European Parliament’s work, which began in 2013, is the revolutionary EU regulation on medical devices commonly known as the MDR (Medical Device Regulation), which was published in 2017. The three-year period planned by the European Parliament for the transition from the MDD and AIMDD* to the MDR has been extended to four years. Thus, the provisions of Regulation (EU) 2017/745 of the European Parliament and of the Council became applicable throughout the European Union on 26 May 2021.
What has changed in the law governing medical devices?
The new regulation has introduced a number of changes for manufacturers, distributors, importers, notified bodies and medical facilities whose activities involve medical devices. The current regulations are much stricter and more closely monitored for a good reason: after all, it is patient safety that is at stake. What exactly has changed? First of all, none of the requirements of the previous directives (MDD, AIMDD) have been removed. However, quite a few new provisions have been added to the existing regulations, some of which are presented below.
Medical devices and their classification
The MDR continues to classify medical devices according to four classes (I, IIa, IIb, III). However, a new subclass has been introduced within Class I devices, catalogued as Ir – reusable surgical instruments. Medical devices of this type must additionally obtain a scope-limited certificate before being placed on the market. In addition, the MDR has a wider scope and classifies some devices differently than the MDD. For devices of a class higher than I, as before, the conformity assessment requires the involvement of a notified body. The biggest change has been felt by manufacturers whose medical devices were not previously covered by the MDD or have changed to a higher class. The new classification rules have forced them to adapt their risk and quality management systems to the new MDR requirements. And all this, of course, before marketing their products (this applies, for example, to all devices for cleaning, sterilisation or disinfection of other medical devices).
Medical devices are regulated by new European Parliament regulations. Operating tables are also subject to these regulations.
Medical devices and notified bodies
Notified bodies have also been affected by major changes. They have to comply with stricter criteria than before the introduction of the MDR. This applies in particular to clinical competence, hence many existing bodies authorised to carry out certification under MDD 93/42/EEC were not approved for notification under MDR. The number of notified bodies in the EU has fallen dramatically, which translates directly into increased certification times for products whose conformity assessment is carried out by a notified body. In Poland, as of today (07.03.2023), only two bodies are authorised (NB 1434 – Polskie Centrum Badań i Certyfikacji S.A. and NB 2274 – TUV Nord Polska Sp. z o.o.). Information on notified bodies can be found in the European database (NANDO).
Clinical investigations
The provisions on clinical investigations of medical devices and performance testing of in vitro diagnostic medical devices have become stricter. The new provisions describe how investigations are designed, authorised, conducted, registered, notified and reported on. So if your facility is involved in clinical investigations or performance testing, read the relevant articles of the MDR carefully. This will provide you with information on all the new obligations.
UDI
The MDR introduces a completely new system of unique device identifiers (UDI). It applies to all medical devices placed on the EU market. An UDI is a barcode, QR code or other machine-readable code. Its purpose is to improve the identification and traceability of products and the effectiveness of post-marketing safety measures. Economic operators (manufacturers and distributors) must be able to identify each health institution or health professional to whom they have directly supplied medical devices.
Ultimately, the UDI should also help to reduce medical errors and to fight against falsified devices. The use of the UDI system should also improve purchasing, waste disposal and stock-management by health and other institutions. Where possible, UDIs should be compatible with other authentication systems already in place in those settings. The UDI code is also the key to publicly available information on devices and investigations in the EUDAMED database.
Medical devices in EUDAMED
A central role in making data available and increasing both the quantity and quality of data is played by the new European database on medical devices (EUDAMED). Its aim is to increase the overall transparency of information. Data covering medical devices and in vitro diagnostic medical devices is now to be even more transparent and accessible. The introduction of this solution is also expected to improve coordination between the different Member States in the EU.
Currently, the database is not yet fully functional. Ultimately, it will consist of six modules. The modules will include operator registrations, unique device identifier (UDI) and device registrations, notified bodies and certificates, clinical investigations and performance testing, market vigilance and surveillance. Currently, only the first 3 modules are available.
MDR and its impact on medical facilities and patients in the EU
There is no doubt that the MDR has dramatically increased the requirements for medical devices placed on the EU market. This translates into safety for healthcare professionals and patients Today, the use of material without medical approval, as in the case of the breast implant scandal described above, is almost impossible. However, if such a situation were to arise, we should be able to easily identify any patient who has received an unsuitable or potentially compromised medical device.
In conclusion, increased requirements for medical devices mean greater safety for all of us – patients and healthcare professionals.
*MDD – Council Directive 93/42/EEC of 14 June 1993 concerning medical devices, AIMDD – COUNCIL DIRECTIVE of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices.
