The quality, performance and safety of medical devices intended for the EU market is the subject of stricter new regulation that has come into effect.
The Medical Devices Regulation (MDR) began to apply on 26 May 2021 and has direct effect in EU member states. Previous EU rules on medical devices and implantable medical devices in place since the early 1990s have been repealed and replaced by the MDR, which now applies to medical device manufacturers, importers and distributors.
There is a separate regulatory framework applicable to in vitro diagnostic (IVD) medical devices. A new IVD Medical Device Regulation was finalised at the same time as the MDR in 2017 but does not come into effect until 26 May 2022.
“The MDR outlines a more robust classification system for goods which qualify as a medical device,” said Dublin-based Erika O’Donnell of Pinsent Masons, the law firm behind Out-Law. “This classification informs which specific requirements the medical device must conform to. Devices are classified according to their risk, with ‘Class III’ and implantable devices subject to greater scrutiny.”
“Now that the MDR has been implemented, manufactures, importers and distributors must conform to the terms of the regulations. It is recommended that businesses within the scope of the new regulation invest in the technology and infrastructure to enable them to comply with the new regulations. Those that fall short of the standards stipulated face having their products removed from the EU supply chain,” she said.
The definition of ‘medical device’ under the MDR covers a diverse range of products, from prosthetics and implants to software, where it is intended to be used for listed medical purposes such as disease or injury diagnosis, prevention or monitoring.
For manufacturers of medical devices for sale within the EU, the new regime requires them to have updated their technical documentation and processes to adhere to the new regulatory requirements. Manufacturers must carry out a “conformity assessment” to satisfy that the medical device meets the necessary safety and performance standards.
O’Donnell said: “Conformity assessments must be undertaken by independent certification bodies designated by national regulators. These are known as ‘notified bodies’, a database for which is maintained by the European Commission. In Ireland, the National Standards Authority of Ireland is the sole notified body currently, and its activities are subject to supervision by the Health Products Regulatory Authority (HPRA).”
Notified bodies have strengthened powers under the MDR to conduct unannounced on-site audits as well as physical or laboratory tests on devices, even after manufacturers have obtained certification for their devices.
The new regulation also requires manufacturers to have quality management systems in place. The regulation stipulates what such a system should comprise, and includes features such as a “strategy for regulatory compliance", a “clinical evaluation” for each device, “processes for monitoring and measurement of output, data analysis and product improvement” and “processes for reporting of serious incidents and field safety corrective actions”.
Each medical device must be certified with a “CE” mark to demonstrate compliance before it is put on the market. Additionally, some devices may require more than one CE mark depending upon whether they are made up of different parts or accessories.
Medical device manufacturers need to designate "at least one person responsible for regulatory compliance who possesses the requisite expertise in the field of medical devices". The regulation lists the minimum qualifications or professional experience candidates for the role must fulfil.
Manufacturers must also establish and maintain a 'post-market surveillance system' (PMSS) which should be "proportionate to the risk class and the type of the device in question”. The PMSS is designed to ensure that any problems identified in the use of medical devices are noted by the manufacturers to prevent future faults or ensure corrective action, as well as "serve the purpose of transparency".
Among the other obligations facing them, manufacturers must ensure they have “sufficient financial coverage” to meet potential product liability claims that may arise.
Importers and distributors also face specific obligations under the MDR, many of which are similar.
Both importers and distributors have a duty to verify that devices have been CE marked, for example, while importers must ensure that the manufacturer or its authorised representative is clearly identified. Distributors must ensure manufacturers have supplied other information along with their device pertaining to its safety and performance.
Importers also have a duty to notify device manufacturers if they “consider or have reason to believe that a device which they have placed on the market” does not conform to the requirements of the MDR. They must cooperate with the manufacturer in such cases, including in withdrawing or recalling the product from the EU market.
Each device must be assigned a unique device identification (UDI) code by the manufacturer for traceability purposes – manufacturers must record the UDI code as well as other data relevant to the devices in an EU database, known as the European Database for Medical Devices (EUDAMED).
O’Donnell of Pinsent Masons said that while the MDR does not apply directly in the UK, the new rules are relevant to British-based businesses manufacturing or supplying medical devices in the EU or Northern Ireland. She said medical device regulation takes account of the unique position of Northern Ireland reflected in the terms agreed around Brexit between EU and UK officials.
“All medical devices placed on the EU market must comply with the MDR,” O’Donnell said. “Legacy products which hold a valid conformity assessment above Class I under the previous Medical Devices Directive may continue to be placed on the market. This may be done until May 2024, when the declaration of conformity expires. Manufacturers must ensure not to alter these products, however, as to do so will cost them their approved status.”
“Under the terms of the Northern Ireland Protocol, different rules apply in Northern Ireland as compared with the rest of the UK when it comes to placing medical devices on the market. The exemption which has been in place concerning the manufacturing or modifying and usage of medical devices and in vitro devices within the same health institution shall continue to apply. However, in addition to the current regime, health institutions wishing to apply the exemption under the new MDR and IVDR must ensure that products meet the relevant general safety and performance requirements, that the appropriate quality system exists, that there is justification for applying the exemption and that the requisite technical documentation is in place,” she said.
“The Medicines and Healthcare products Regulatory Agency in the UK has helpfully published guidance on implementing the health institution exemption in Northern Ireland,” O’Donnell said.
The MDR was supposed to come into force in 2020, but its application was delayed by 12 months to enable device manufacturers to focus all their efforts on addressing the challenges posed by the coronavirus crisis.