MIL OSI – Source: European Union –
Headline: Medical devices: agreement on new European rules
On 25 May the Council of the European Union, under its current Dutch Presidency, and the European Parliament reached a provisional agreement on new rules for medical devices and in vitro diagnostic products. The agreement still has to be formally approved by the Council and the European Parliament. The aim of the new rules is to ensure that medical devices and in vitro diagnostics products are safe and to give patients fast access to new innovative devices.
Creating conditions for the internal market
Medical devices and in vitro diagnostics products range from sticking plasters, artificial hips and pacemakers to laboratory tests and home pregnancy tests. ‘This is an important step for all people in Europe,’ said Dutch health minister Edith Schippers, ‘because sooner or later we all need medical devices. Safe, innovative medical devices improve patients’ quality of life and health. The new rules will also create the conditions needed for a properly functioning internal market for the 25,000 manufacturers of medical devices in the EU, many of them SMEs, which employ over half a million people.’
Strengthening the system
The new rules will guarantee the safety of medical devices in two ways: by introducing stricter rules on the marketing of devices and closer monitoring once they are on the market. The requirements for the notified bodies responsible for market authorisation will be tightened up, as will supervision of these organisations. They must have well-qualified, independent staff to properly assess new devices and conduct unannounced inspections of manufacturers.
Clear responsibilities for manufacturers
Clear rules have also been set out for manufacturers to guarantee the quality, performance and safety of devices once they have been granted market access. This will enable rapid intervention, and provide information that can be used for product improvement. Manufacturers and other commercial parties will also be given other clear responsibilities, concerning matters such as liability and the registering of complaints about their devices.
Stricter requirements for clinical trials
The new regulations will also introduce stricter requirements for clinical trials and performance testing. This will make more reliable clinical data available on medical devices and in vitro diagnostic products. Protection of human subjects in clinical trials is another key focus.
More stringent rules for high-risk devices
Extra testing by experts may be required before some high-risk medical devices, such as implants and in vitro diagnostic products for life-threatening diseases, can be marketed. Panels of independent experts and laboratories will play an important role in the future legislative system. If necessary, they can give designated bodies, competent authorities and manufacturers expertise and advice on the clinical aspects of medical devices. Certain high-risk products that are similar to medical devices but are not currently subject to any rules, such as wrinkle fillers and coloured contact lenses, will also be covered by the regulation.
More transparency for patients and better traceability
Transparency on medical devices will be hugely improved, with a large database of devices containing a host of information about manufacturers, importers, distributors, notified bodies, market surveillance data, clinical trial results and certificates. Patients, healthcare professionals and the general public will have access to detailed information about products available on the European market, allowing them to make better-informed choices. Patients with an implant will also be given specific information about the product, including any necessary precautions. Manufacturers will be obliged to give their device a unique identification code, making it more traceable throughout the entire distribution chain, so that action can be taken more quickly should any risks become apparent.
The Presidency will present the outcome of the negotiations to the member states for their approval in mid-June. The European Parliament will probably vote on it in a plenary session in the autumn. The new rules for medical devices will come into force three years after publication, those for medical devices for in vitro diagnostic products five years after publication.