MDR Language Requirements in Finland

Introduction

Finland, a captivating Nordic country, boasts breathtaking landscapes, a vibrant culture, and a top-notch healthcare system. As an EU Member State, it aligns its medical device regulations with EU guidelines, ensuring the safety and effectiveness of these devices within its borders.

The official languages in Finland are Finnish and Swedish. Finnish is the predominant language spoken by the majority of the population, approximately 85.9% of the people in Finland speak Finnish as their native language. Swedish is the second official language and is spoken by about 5.2% of the population, particularly in coastal areas and regions where Swedish-speaking communities are present. Both Finnish and Swedish have equal status as official languages at the national level, and all government institutions and public services provide information and services in both languages.

The medical device industry in Finland is a vital contributor to its economy, offering essential healthcare solutions. All medical device regulations adhere to the EU's MDR and IVDR, enhancing safety, traceability, and post-market surveillance across member states.

FIMEA stands for the Finnish Medicines Agency, also known as Lääkealan turvallisuus- ja kehittämiskeskus in Finnish. It is the regulatory authority responsible for overseeing and regulating medical devices and medicinal products in Finland. FIMEA operates under the Ministry of Social Affairs and Health.

By decision of the Finnish Parliament and published by the Ministry of Social Affairs and Health the new Medical Device Act 719/2021 came into force to implement the Regulation (EU) 2017/745 of the European Parliament and Council on medical devices.

Language Requirements for Labeling and Instructions for Use (IFUs)

According to Section 5 of the Medical Devices Act (719/2021):

“The information and documents referred to in Article 10 (11) [Annex I, section 23] of the MD Regulation and in Article 10(10) of the IVD Regulation must be in Finnish, Swedish or English, unless the information is provided in the form of internationally recognised symbols.” 

However, there might be exceptions. The legislation stresses that “information necessary for the safe use of a device must, however, be available in Finnish and in Swedish”, so only in the official national languages.

The legislator leaves the responsibility in the hands of the manufacturers’ risk assessment of the concerning device, they must determine which information is necessary for the safe use.

The Finnish legislator makes a difference “if the device is intended for use by patients or other consumers […]”, which means lay person users. In that case all necessary information "must be available in Finnish and Swedish".

Language Requirements for the Declaration of Conformity

The DoC acts as a critical component for placing a medical device on the market in the European Union (EU). It demonstrates to authorities and healthcare providers that the device meets the MDR's safety and performance benchmarks.

According to the Finnish Medical Device Act, section5, this information can be provided in three languages: Finnish, Swedish or English. It’s up t the manufacturer to decide.

Language Requirements for the Implant Card

Manufacturers of approved implantable medical devices certified according to the MDR should provide the required information on an implant card delivered with the device, unless the device is exempt by virtue of MDR Article 18 paragraph 3. The following implants are exempt from the implant card obligations: sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips and connectors.

According to Finnish regulation 719/2021, section 5, implant cards must be provided in three languages: Finnish, Swedish, and English. Just translating your card into Finnish and Swedish isn't enough.  For compliance, English must always be included on the implant card.

Language Requirements for the Field Safety Notice

The field safety notices (FSN) play a crucial role in the post-market surveillance system. They ensure that any identified safety concerns are effectively communicated to relevant parties to minimize potential risks for patients.

Manufacturers are obligated to issue an FSN under the following circumstances:

• When they identify a serious incident directly related to their device.
• When they receive reports of serious incidents suggesting potential safety issues.
• When they conduct a risk assessment that reveals a previously unknown safety concern.

The Finnish legislator determines:

“The notices referred to in Article 89(8) of the MD Regulation and in Article 84(8) of the IVD Regulation must be drafted in the languages necessary for safety.”

However, the Finnish Medicines Agency reserves the right to “order the manufacturer to draft a notice free of charge in a certain language or languages” (719/2021, section 5). This may require urgent and translation needs.

Language Requirements for Conformity Assessment Documentation

The conformity assessment documentation is essentially a big pile of paperwork a manufacturer needs to keep to prove their device meets all the MDR's safety and performance requirements. 

The Finnish Medical Device Act summarizes it this way:

“The documents referred to in Article 52(12) of the MD Regulation and in Article 48(12) of the IVD Regulation must be available in Finnish, Swedish or English.” 

However, the Finnish Medicines Agency “may when required by safety, order the manufacturer and the authorized representative to submit, free of charge, the information and documents referred to in Article 10(14) and Article 11(3)(2)(d) of the MD Regulation and in Article 10(13) and Article 11(3)(2)(d) of the IVD Regulation or their parts defined by the Agency in Finnish or in Swedish.” (719/2021, section 5)

A lot of references to bear in mind, right? The documents you need to be careful with in a nutshell: 

• Reports of serious incidents and field safety corrective actions (Article 10(13))
• The mandate for the authorized representative which needs to be presented to competent authority, in this case the Finnish Medicines Agency (Article 11(3)(2)(d) MDR).

Conclusion

MDR compliance in Finland requires navigating language regulations. While some documents can be in English, critical information for safe use must be in Finnish and Swedish. Accurate translation of labeling, instructions, and safety notices is vital. Partnering with a qualified medical language provider ensures expertise, cultural awareness, regulatory compliance, and quality assurance, ultimately promoting patient safety and a smooth Finnish market entry for your medical device.