New medical devices legislation proposed to improve patient safety
News from the Ministry of Social Affairs and Health and the National Agency for Medicines
A Finnish Government proposal has been drafted to clarify the liability of authorities, businesses and professional users of medical devices, with the aim of improving patient and occupational safety and promoting the safety of medical devices. Initiated by the Ministry of Social Affairs and Health, the proposal was prepared by the National Agency for Medicines.
The suggested clarifications to the liability of device manufacturers, distributors and professional users as well as the duties of supervisory authorities will make the situation clearer from the perspective of all those operating in the sector. They will also help realise the ultimate purpose of the legislation – ensuring device safety. Another aim of the proposal is to amend Finnish legislation so it will clearly present the system of supervision concerning medical devices and the relationship of national provisions to EU provisions. This will be particularly beneficial for Finnish device manufacturers planning to launch their products in the European single market.
The proposal clarifies the division of liability, with provisions suggested including the obligation of the distribution chain and professional users to comply with the manufacturer's instructions. Also proposed is an obligation for professional users to maintain a performance monitoring system regarding compliance with obligations laid down in the Medical Devices Act. Organisations and teachers using medical devices for educational purposes are also to be assigned professional user’s liability regarding the use of such devices. The proposal also specifies the requirements that health care units must meet in their own device production.
Current Finnish legislation does not enable comprehensive and efficient supervision of product safety. Devices are becoming more complex and their number in the market is increasing. This calls for legislation to ensure that there are sufficient supervision measures available to authorities. Efficient supervision is also beneficial to businesses as it guarantees equal competition conditions.
If adopted, the revised Medical Devices Act will replace the current Medical Devices Act (1505/1994) and implement Directive 2007/47/EC.
The drafting process has involved consultation by the National Agency for Medicines with several actors in the field of devices and supplies as well as professionals using them. The closing date set by the Ministry of Social Affairs and Health for opinions on the proposal is 10 November 2008.
You can read more about the proposal on the National Agency for Medicines website (in Finnish).
Further information:
Marja-Liisa Partanen, Deputy Director-General, Ministry of Social Affairs and Health, tel. +358 (0)9 160 73804, +358 (0)50 559 9169
Professor Tomi Kauppinen, Head of Department, National Agency for Medicines, tel. +358 (0)9 4733 4241
Ilona Rintanen, Legal Officer, tel. +359 (0)9 4733 4479