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MD/IVD Regulation causes changes to national legislation in EU member states

 A new Finnish national legislation has entered into force

The requirements on medical devices in the EU were significantly tightened, while harmonized with the MD Regulation (2017/745) and the IVD Regulation (2017/746). Under the transitional framework, the MD and IVD Regulations replace the previous Medical Device Directives (90/385/AIMD, 98/79/IVDD and 93/42/MDD).

The transition from directives to regulation also affects the national legislation of the EU member states. For example, in Finland, the Directives have been implemented by the law Laki terveydenhuollon laitteista ja tarvikkeista, known as the TLT-Law (TLT-law 629/2010). The MD and IVD regulations are directly applicable legislations in EU member states without requiring transposition through specific national legislation. However, national legislation is still needed to set requirements for elements not regulated in the Regulations. And for this reason, a new law called Laki Lääkinnällisissä laitteista (719/2021) entered into force in July in Finland.

Noteworthy in the law 719/2021 is that there will be an annual fee that National Competent Authority Fimea will invoice from economical actors acting in Finland. This applies not only to manufacturers but also to other economic operators such as distributors and importers. It should be noted that a company may have several roles based on the activities they perform. In that case, a company will be invoiced fees separately for each role.

The law 719/2021 includes also national aspects on language requirements, clinical investigation, and performance evaluation studies.

In addition to the law 719/2021, the old TLT-Law remained partially in force, but its name was changed to Laki eräistä EU-direktiiveissä säädetyistä lääkinnällisistä laitteista. The old law is necessary because the IVD Directive is still in force until spring 2022 and, according to the transitional provisions of the Regulations, medical devices can still be placed on the market during the transitional period under the Directives.

With the on-going transition periods and national legislations, the regulatory environment in the EU for medical devices is complex. In case you have any questions about MD/IVD legislation or applicable national legislations, please do not hesitate to contact DRA’s HT team. We are here to find the best solutions for you!