2020/0645/S
EC/EFTA
SE Schweden
  • S10S - Medizinprodukte
2021-01-13
2020-10-19

Medical devices

Draft Act with supplementary provisions to EU regulations on medical devices

The current draft Act intends to adapt Swedish legislation to the EU regulations on medical devices. The EU regulations referred to are Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (MDR) and Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU (IVDR).

Sweden intends to introduce national requirements for clinical investigations that are not conducted for the purposes listed in Article 62(1) of the MDR. Scope for introducing such national requirements can be found in Article 82(2) of the MDR.
Sweden also intends to introduce transitional provisions for the medical devices that have been placed on the market, provided and put into service before the EU regulations begin to apply. Current Swedish provisions will continue to apply to these devices.
1. The provisions on clinical investigations in the MDR, the Act with supplementary provisions to EU regulations on medical devices and regulations issued in connection with the Act will also apply to a clinical investigation not conducted for any of the purposes set out in Article 62(1) of the MDR. Such investigations are to be subject to authorisation in accordance with Article 70(7)(b) of that Regulation. The government, or the authority appointed by the government, may issue regulations regarding exemptions from the requirements stated in the first paragraph. The authority appointed by the government may, in individual cases, decide on exemptions from such requirements. Decisions may be combined with special conditions (Chapter 2, § 6 of the draft Act with supplementary provisions to EU regulations on medical devices).
2. Older regulations still apply for:
(a) medical devices placed on the market or put into service before 26 May 2021 (excluding products covered
by paragraphs 5 and 13 and products placed on the market in accordance with the MDR); and
(b) in vitro diagnostic medical devices that have been placed on the market or put into service before 26 May 2022 (with the exception of the devices covered by paragraphs 6 and 13 and the devices placed on the market in accordance with the IVDR) (paragraph 4 of the transitional provision of the draft Act with supplementary provisions to the EU regulations on medical devices).

Older provisions on supervision, penalties, confiscation and fees in the repealed Act will continue to apply as long as the provisions of that Act apply (paragraph 17 of the transitional provisions of the draft Act with supplementary provisions to EU regulations on medical devices).