New medical devices regulations
On 26 May 2021, a new EU medical device regulation (MDR) entered into force. Medical devices cover anything from contact lenses to state-of-the-art surgical equipment. A new in vitro diagnostic medical devices regulation (IVDR) will follow next year, entering into force on 26 May 2022. In vitro diagnostics are tests done on samples such as blood or tissue and can be used to detect diseases or other conditions.
The new regulations replace the previous directives, 90/385/EEC (MDD) and 93/42/ECC (IVDD). The IVDD will remain in force until 26 May 2022.
The aim of the new regulations is to strengthen patient safety and to ensure that new devices will benefit patients, e.g. by supporting the availability of devices and enhancing the monitoring of them.
Reinforced supervision and control of medical devices
The regulations tighten the rules for testing medical devices on patients to ensure the availability of documentary evidence of device testing. In addition, manufacturers of medical devices must meet stricter requirements as regards following up on the quality, performance and safety of devices.
The rules are also tightened for notified bodies and for the authorities’ monitoring of notified bodies. Notified bodies are responsible for assessing medical devices in medium- and high-risk classes before medical devices can be marketed in the EU. The new regulations also give the notified bodies a right and a duty to carry out unannounced on-site inspections at the manufacturer. Further information on the different risk classes is available here.
New European database
The new regulations also imply an update to Eudamed, the central European database on medical devices. The new Eudamed will include information about manufacturers, notified bodies, clinical investigations, certificates, medical devices as well as injuries caused by medical devices and/or medical device malfunction or failure. The database will moreover include information about medical devices marketed in the EU. Authorities, patients and healthcare professionals will have full access to Eudamed, whereas the public will only be able to access the database’s non-confidential information about manufacturers and medical devices.
The launch and use of Eudamed are scheduled to take place in the fourth quarter of 2022.
The new regulations moreover require medical devices to have a Unique Device Identification (UDI) to ensure traceability throughout the supply chain from manufacturer to patient.
Notes for manufacturers
Article 59 of the MDR provides that the national authorities may authorise the use of a specific device even though the conformity assessment procedures have not been carried out if the use of the device in question is in the interest of public health or patient safety or health. Article 59 has been in use since 24 April 2020. A similar possibility is available in article 54 of the IVDR, which will become effective with the entry into force of the regulation on 26 May 2022.
The European Commission has the possibility of extending national derogations to the entire territory of the Union.
The European Commission has introduced a UDI Helpdesk for operators in the fields of medical devices and in vitro diagnostic medical devices . This helpdesk aims to provide support to economic operators in the implementation of the obligations and requirements introduced by the new UDI system, which include UDI assignment, labelling and registration of devices.
The helpdesk can also provide support as regards the use of the European Medical Devices Nomenclature (EMDN), which the European Commission has made available to the manufacturers and other natural or legal persons required by the MDR and IVDR to use it.
Products with living micro-organisms
The new MDR regulation implies that it is no longer possible to market medical devices that contain or consist of viable biological material or viable organisms, including living micro-organisms, bacteria, fungi or viruses in order to achieve or support the intended purpose of the product. This appears from article 1(6)(h) of the medical devices regulation (MDR 2017/745).
Any product containing the above-mentioned organisms is thus outside the scope of the regulation even if the product in question may have a certificate that has not expired and was issued under the previous medical devices directive.
It is up to the manufacturers of such products to determine if the products can be marketed under other rules, e.g. the rules regulating food supplements, cosmetics or medicinal products.
Why are the new rules necessary?
Medical devices and in vitro diagnostic medical devices are becoming more and more advanced and innovative. The current rules date back to the 1990s, and the legislation has not kept abreast of the scientific and technical developments that have taken place in the healthcare sector.
Traceability across the EU is difficult as many member states have set up their own registers, and these are not always compatible with each other. The use of different systems in different countries is also an unnecessary burden for manufacturers who want to market their products in more than one country.
The new regulations also serve a dual purpose of improving the safety of medical devices and stimulating innovation. The medical device industry is developing fast. The relatively short development life cycle of medical devices means that new products enter the market continuously, and that makes it even more important to ensure access to safe medical devices and in vitro diagnostic medical devices for public health and medical treatments.
Changed risk classification of in vitro diagnostic medical devices
The in vitro diagnostic medical devices regulation changes the classification of devices to four risk classes in line with the classification already used for other medical devices.
The risk classification for in vitro diagnostic medical devices will affect:
- the obligations of manufacturers and other economic operators,
- the requirements for clinical investigation and clinical evidence,
- the requirements for market surveillance by the national authorities.
Further information on the new IVD classification is available in Annex VIII of the regulation.
Factsheets on the regulation for
- manufacturers of medical devices
- manufacturers of class I medical devices
- manufacturers of in vitro diagnostic medical devices
- manufacturers of implantable medical devices
- healthcare professionals and healthcare institutions
- the procurement ecosystem of medical devices and in vitro diagnostic medical devices
- authorised representatives, importers and distributorof medical devices and in vitro diagnostic medical devices
Why are the new regulations needed?
Medical devices and in vitro diagnostic medical devices are becoming ever more sophisticated and innovative. Existing rules date back to the 1990s and have not kept pace with scientific and technical developments in the healthcare sector.
Medical devices not subject to pre-market authorisation
Traceability across the EU is difficult, because several member states have set up own registration tools that are not always compatible with each other. The use of different systems in different countries also place an unnecessarily heavy burden on manufacturers who want to market a product in more than one country.
In addition to improving the safety of medical devices, the new regulations seek to stimulate innovation. This is necessary as it is estimated that in 2060 there will be twice as many Europeans aged 65 or over, increasing the importance of safe and accessible medical devices and in vitro diagnostic medical devices for public health and medical care.
Changed classification rules for in vitro diagnostic devices
The regulation on in vitro diagnostic medical devices (IVD) will classify in vitro diagnostic medical devices in four risk categories, in line with the categorisation that already exists for other medical devices.
The risk classification of in vitro diagnostic devices will determine:
- The obligations placed on manufacturers and other economic operators
- The requirements for clinical investigations and clinical evidence
- The requirements for market surveillance by national authorities
Read more about the new classification of IVD in Annex VII to the new regulation.