The European Commission has welcomed the adoption of its proposal for two regulations which establish a modernised and more robust EU legislative framework to ensure better protection of public health and patient safety.
Having experienced various high profile incidents, such as the PIP Breast implants scandal, and with medical device recalls increasing, the EC hopes the new regulations on medical and in-vitro diagnostic medical devices proposed by the Commission in 2012 will help to ensure that all medical devices – from heart valves to sticking plasters to artificial hips – are safe and perform well.
To allow manufacturers and authorities to adapt, the new rules will only apply after a transitional period. The set of rules covering IVDs will take effect in 2022, while another set of rules covering medical devices will become effective in 2020.
The commission says the new rules will “improve market surveillance and traceability as well as make sure that all medical and in vitro diagnostic devices are designed to reflect the latest scientific and technological state-of-the art”.
The rules are also designed to provide more transparency and legal certainty for producers, manufacturers and importers and help to strengthen international competitiveness and innovation in this strategic sector.
The rules provide for:
- Random inspections of producers’ facilities after devices have been placed on the market
- Stricter controls on notified bodies, which will have to employ medically skilled people
- An additional safety checking procedure for high risk devices, such as implants or HIV tests
- An "implant card" for patients, enabling patients and doctors to track which product has been implanted
- Clinical evidence of medical device safety to be provided by manufacturers (as for medicines), especially in the case of higher risk classes.