The European Union established regulations for medical device performance and safety in the 1990s. The European Parliament and Council passed Regulations (EU) 2017/745 and (EU) 2017/746 in April 2017 to strengthen the legal framework governing medical devices and in vitro diagnostic devices. The goal of these Regulations is to achieve a high level of protection of health for patients and users and to ensure the seamless operation of the internal market for medical device products. The Regulations outline a more comprehensive system of conformity assessment to guarantee the quality, safety, and performance of devices placed on the EU market.
The Medical Devices Regulation came into effect in May 2017 and became applicable on 26 May 2021. The transition period provided for in the Regulation will come to a conclusion on 26 May 2024. Medical devices that are released onto the market before or during the transition period and are still in the supply chain when the transition period ends may still be obtained up until May 2025 under a separate "sell-off" option.
The In Vitro Diagnostic Medical Devices Regulation, which took effect on May 26, 2022, is a supplement to the Medical Devices Regulation. The European Parliament and Council decided in January 2022 to extend the transition period in stages, starting with high-risk in vitro diagnostics on May 26, 2025, moving to lower-risk in vitro diagnostics on May 26, 2027, and ending with certain provisions involving devices made and used in healthcare facilities on May 26, 2028.
What are the main benefits for patients?
More than 500,000 distinct types of medical equipment are available on the market. Most people will at some point in their lives need to use a medical gadget, ranging from simple bandages to hip replacements. The Regulation has paved the way for a more patient-centered healthcare system in which patients can benefit from cutting-edge, highly effective technologies and novel therapies and where transparency, patient information, and patient choice are given top priority.
The upgrades include tighter ex-ante controls for high-risk devices, strengthening of the standards for the designation and control of Notified Bodies, like Certrust, and stepping up post-market surveillance.
What is the role of Notified Bodies?
Medical devices, particularly in vitro diagnostic medical devices, are not subject to a regulatory authority's pre-market authorization, in contrast to pharmaceuticals. Instead, medium- and high-risk devices are subject to a conformity evaluation process including a 'notified body,' a non-governmental organisation that is not related to the manufacturer.
The Member States designate and oversee notified bodies, which operate under the supervision of the national authorities. A committee made up of representatives from the Commission and other Member States has been working together to evaluate notified entities since 2013. The accomplishment of these joint assessments for the identification of notified bodies is strengthened by the new framework.
Most often, notification bodies are private, for-profit organisations. Therefore, their establishment is motivated by the market. The standards that must be satisfied by notified organisations have been dramatically tightened by the Medical Devices Regulation, affecting how long the designation process takes.
What else is the Commission doing to ensure full implementation of the Medical Devices Regulation?
On August 25, 2022, the Medical Device Coordination Group (MDCG), which is presided over by the Commission, approved a position paper outlining 19 non-legislative actions to improve notified body capacity, manufacturers' readiness, and access to notified bodies in order to facilitate a smooth transition to Regulations (EU) 2017/745 and (EU) 2017/746.
The MDCG position paper on hybrid audits updated MDCG guidelines on appropriate surveillance, and a revision of MDCG 2019-6, reducing barriers to the recruitment of qualified employees by notified bodies, are only a few of the initiatives outlined in that position paper that has already been put into practise. The Commission passed two delegated acts on December 1, 2022, postponing the first full reevaluation of notified bodies. This should free up resources for both notifying bodies and designating authorities.
The remaining MDCG 2022-14 actions are still being put into effect since they are still crucial even if the transition time is prolonged. In order to bridge the gap between the expiration of certificates issued under Council Directives 90/385/EEC and 93/42/EEC and the issuance of a certificate under the Medical Devices Regulation, the MDCG published a position paper on December 9, 2022, which is available online.
This strategy is supposed to be a stopgap until the legislative modifications in today's Commission recommendation become effective. It helps to keep the supply of medical devices on the EU market from being disrupted. However, it is not seen as a sustainable option for tackling the anticipated bottleneck of expiring certificates by 26 May 2024, given the quantity of certificates expiring in 2023 and 2024.
The 2022 and 2023 work programmes of the EU4Health Programme additionally (co-)fund additional initiatives to aid in the implementation of the two Regulations. These include a targeted action to support notified bodies' capacity with a focus on SMEs, a joint action to support strengthened coordination between member states on market surveillance, a study to evaluate the current regulatory governance for medical devices and its impact on innovation, a survey of key market participants, including notified bodies and manufacturers, SMEs, and a programme on orphan medical devices, specifically focusing on paediatric devices. The Enterprise Europe Network will also be used by the Commission to spread awareness of regulatory requirements.
In order to bridge the gap between the expiration of certificates issued under Council Directives 90/385/EEC and 93/42/EEC and the issuance of a certificate under the Medical Devices Regulation, the MDCG released a position paper on December 9 that outlines a uniform approach for competent authorities to apply market surveillance measures. This strategy is supposed to be a stopgap until the legislative modifications in today's Commission recommendation become effective. It helps to keep the supply of medical devices on the EU market from being disrupted. However, it is not seen as a sustainable option for tackling the anticipated bottleneck of expiring certificates by 26 May 2024, given the quantity of certificates expiring in 2023 and 2024.
The 2022 and 2023 work programmes of the EU4Health Programme additionally (co-)fund additional initiatives to aid in the implementation of the two Regulations. The following are some of them: a targeted action to support notified bodies' capacity with a focus on SMEs; a joint action to support enhanced coordination between member states on market surveillance; a study to evaluate the current regulatory governance for medical devices and its impact on innovation; a survey of key market participants, including notified bodies and manufacturers, including SMEs; and a programme on orphan medical devices, specifically aimed at paediatric patients.
The Enterprise Europe Network will also be used by the Commission to spread awareness of regulatory requirements.
What is the medical devices database EUDAMED about?
A key component of the new regulatory framework, EUDAMED represents a significant advance in ensuring traceability and transparency in the medical device industry. An overview of all medical devices accessible in the European Union will be given. UDI and device registration, notified bodies and certificates, clinical investigations and performance studies, vigilance, and market surveillance are the six parts that will make up this system. It will combine data about medical gadgets and connected businesses (such as manufacturers) with information from other electronic systems.
The first EUDAMED module on actor registration will be made available in December 2020 as the project is moving forward. With the exception of the mechanism for scrutiny and the clinical evaluation consultation procedure functionalities (CECP), which are only applicable to medical devices like implants and not in vitro diagnostics, the second and third modules, UDI/device registration and certificates and notified bodies, have been available since the beginning of October 2021.
When EUDAMED is completely operational, the other modules as well as the capabilities for the mechanism for scrutiny and the CECP will be made available. On this extremely complex undertaking, the Commission will continue to work closely with the Member States.