On 25 May 2016, the European Parliament adopted the final draft of two new Regulations on Medical Devices and In Vitro Diagnostic Medical Devices, modernising the regulatory framework and taking as a base a high level of protection of health throughout the European Union.
The two Regulations will replace the current Medical Devices Directive, the Active Implantable Medical Devices Directive, and the In Vitro Diagnostic Medical Devices Directive, and improve safety, transparency and traceability of all medical devices within the EU. The three Directives are leaving room to divergent implementations at country level, whereas, through the Regulations, the EU seeks to establish a homogeneous regulatory framework, with direct effect in the legal systems of EU Member States.
Significant changes are introduced in the new regulatory framework to ensure high standards of quality and safety for medical devices, by strengthening the rules on placing the devices on the market and increasing the post marketing surveillance obligations. The key innovations include changes in the field of:
- Conformity assessment procedures
A risk based classification system of the medical devices and in vitro diagnostic medical devices (from class I – low risk- to class III – high risk- for medical devices; and from class A – low risk- to class D-high-risk- for in vitro diagnostic medical devices) will determine, for high risk devices, the increased extent of the manufacturers’ obligations to conduct clinical investigations to provide clinical evidence of the devices performance and to demonstrate the conformity of the devices placed on the UE market with the quality and safety requirements, and of the involvement of notified bodies in the initial assessment and post-market surveillance.
- Supervision of notified bodies
The Regulations include new responsibilities for the notified bodies in charge of the initial conformity assessment of high risk devices. The new responsibilities include, among others, unannounced audits on the manufacturers’ factories and post market surveillance. Moreover, new criteria have been established in order for national competent authorities to designate and monitor the notified bodies to ensure a harmonised enforcement of the pre and post-marketing controls.
- Clinical investigations and evaluations
The Regulations set out requirements to conduct clinical evaluations and clinical investigations (for the medical devices) and clinical performance studies (for in vitro diagnostic medical devices) to demonstrate the devices’ compliance with the general safety standards and specifications. The sponsor, who may be either the manufacturer or any legal or natural person contractually mandated for this purpose, will be responsible for setting up, managing and organising the financing of the clinical investigations and performance studies. Any clinical investigation or study will be recorded and reported in a publicly accessible database.
- Vigilance and market surveillance
The Regulations introduce increased responsibilities for manufacturers and operators to follow up on the quality and safety of the devices, once they are placed on the market. The post-market surveillance system will be set up under the Quality Management System of the device manufacturer (or its authorised representative in the EU if the manufacturer is not established within the EU), who will have to appoint a person in charge of the regulatory compliance of the post-market phase. Further, during the device’s life cycle, the manufacturer will have to continuously update any part of the device documentation, with any data or information collected or received concerning, for instance, the risk assessment or the clinical evaluation or performance of the device.
- Transparency and traceability
The manufacturers will have to register each device under a Unique Device Identification number to facilitate the post-marketing traceability. Further, the pre-existing Eudamed database will be further developed, to register and publish all the information related to the devices, the manufacturers, the authorised representatives, and the clinical evaluations and investigations. All incidents and safety corrective actions will also be recorded in this database to provide more transparency and legal certainty.
- Coordination between competent authorities
The Regulations provide for closer coordination between national authorities through information exchanges and coordinated assessments of notified bodies’ activities or of serious incidents reported that affect more than one EU Member State. The EU Commission, assisted by committees and groups of experts, will provide support to the national authorities to ensure the full implementation of the new regulatory framework and facilitate international regulatory cooperation to exchange safety related information about the devices with non EU authorities.
- Transition period
The Medical Device Regulation will become applicable three years after their entry into force, and the In Vitro Diagnostic Medical Device Regulation five years thereafter. Current expected dates are thus, respectively, end of 2019 and 2021.