New EU medical devices laws nearly finalised with effect likely from 2020

The Council of Ministers has released what could be the final text of two proposed new regulations for medical devices (566-page / 2.45MB PDF) and in vitro diagnostic medical devices (477-page / 2.17MB PDF). According to a report by the BSI, the text will be voted on by the Council on 7 March and the Parliament on 20 March, and could be in force as early as May this year. The new medical devices regulation and new in vitro diagnostic medical devices regulation would then come into effect in 2020 and 2022 respectively.

The most recent proposals come years after the European Commission first published its plans for reforms to the existing ways medical devices are regulated in the EU. The Council and the Parliament reached a political agreement on the reforms last summer.

The Council's latest proposals take into account amendments suggested by MEPs, it said, and will come into force if the Council and Parliament both vote to approve the legislation.

In a statement, the Council said the new regulations "aim at modernising the existing legislative framework for the marketing of medical devices and to overcome legal gaps, thereby supporting innovation and the competitiveness of the medical device industry".

It said the new rules "should further strengthen patient safety, notably through the introduction of more stringent procedures for conformity assessment and for post-market surveillance and through requirements on manufacturers to generate clinical data providing evidence on safety, performance and any undesirable side-effects" and also "allow rapid and cost-efficient market access for innovative medical devices".

Like existing rules, there is no formal system for pre-market authorisation of medical devices envisaged under the new regulations. However, medical devices would have to establish an evolving 'quality management system' to ensure compliance.

The quality management system must include, among other things, "a strategy for regulatory compliance" and a 'clinical evaluation' for each device, which medical device manufacturers are obliged to carry out to demonstrate their compliance with set safety and performance requirements.

A clinical evaluation is defined as a "systematic and planned process to continuously generate, collect, analyse and assess the clinical data pertaining to a device in order to verify the safety and performance, including clinical benefits, of the device when used as intended by the manufacturer".

Medical device manufacturers must also designate "at least one person responsible for regulatory compliance who possesses the requisite expertise in the field of medical devices". That person must be either formally qualified or professionally experienced for the role.

For traceability purposes, most medical devices will have to have unique identifiers. Those details will be recorded in an EU database.

Medical device manufacturers must continue to make an EU declaration of conformity for their devices, and most of the products must bear a 'CE' marking to certify that compliance.

As part of their quality management system, manufacturers must also establish a 'post-market surveillance system' (PMSS) which should be "proportionate to the risk class and the type of the device in question", according to the Council proposals.

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".

"The post-market surveillance system shall be suited to actively and systematically gathering, recording and analysing relevant data on the quality, performance and safety of a device throughout its entire lifetime, and to drawing the necessary conclusions and to determining, implementing and monitoring any preventive and corrective actions," according to the proposed new medical devices regulation.

A 'medical device' is considered to come in many forms, including software, where it is intended to be used for set medical purposes, including disease or injury diagnosis, prevention or monitoring.