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New EU medical devices regulations expected to be finalised in April


Planned reforms to the regulation of medical devices are expected to be finalised in April, the EU's Council of Ministers has said.

The Council voted to adopt new EU regulations on medical devices (566-page / 2.47MB PDF) and in vitro diagnostic medical devices (477-page / 2.18MB PDF) on Tuesday. The regulations will come into force if MEPs also vote them into law and once they are subsequently published in the Official Journal of the EU. The European Parliament's vote is expected to take place in April, the Council said.

The new regulation on medical devices will apply three years after the date on which it is published in the OJEU, and the new regulation on in vitro diagnostic medical devices will apply five years after its OJEU publication date.

"Medical devices play a crucial role in all our lives," Christopher Fearne, Malta's health minister and president of the Council, said. "We all regularly use sticking plasters or have dental fillings, and we know people who are still alive thanks to devices that have helped in the diagnosis and treatment of serious diseases. These new rules will do more to help save lives, by having more innovative and safer devices on the market."

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.

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