Regulation
The MD and IVD regulations (EU 2017/745 and EU 2017/746) entered into force in 2017 and will be applied instead of the previous directives without separate implementation, i.e. they are directly applicable in Finland.
MD and IVD regulation (EU 2017/745 and EU 2017/746) entered into force in 2017 and will be applied instead of the previous directives without separate implementation, i.e. they are directly applicable in Finland. In the future, national regulation can only exist in addition to regulation to the extent that the regulation separately require or allow it. The application of regulation is mainly guided by MDCG Guidance documents, which are not legally binding, but are very important for making uniform interpretations of regulations.
The MDR became fully applicable in May 2021 and will replace the previous MD and AIMD directives. IVDR gradual application began on 26 May 2022 and will replace the IVD Directive.
The MDR is based on the regulation of the medical device directives and the guidelines that supplement them. However, with the regulation, there will be many tightening of requirements, with the goal of improving patient safety in the European Union.
The application periods of the regulations have been staggered by a number of transitional periods. As a result, due to transitional periods, both medical devices complying with the old directives and medical devices complying with the new regulations may be on the market for years.
Health technology field is one of the most regulated sectors in the world
In order for a medical device to be legally placed on the EU market, the manufacturer must have the CE marking for the product. The label indicates that the products comply with applicable EU regulation and requirements and enables the free movement of equipment in the EEA and Turkish markets. The CE mark itself does not say anything about the country of manufacture.
National regulation complementing regulations
Two new laws supplementing the medical device regulations have been passed in Finland.
A completely new law on medical devices (719/2021) came into force on 19 July 2021 and complements the provisions of both the MD and IVD regulation. In some respects, the law in question contains requirements common to all devices, including those relating to a professional use and the obligation to register.
The Act on Certain Medical Devices provided for in EU Directives (629/2010) also entered into force on 19 July 2021. This law was needed because the IVD Directive, which precedes the IVD Regulation, will continue to apply until the transition periods of the new Regulation have expired. In addition, to the extent that devices complying with the AIMD and MD directives may continue to be placed on the market and put into service under the MD Regulation, the provisions of this Act shall apply nationally.
