The national implementation of the Medical Devices Regulation 2017/745 (MDR) and In Vitro Devices Regulation 2017/746 (IVDR) in Finland is regulated through the Finnish Medical Devices Act 719/2021, including also other complementary legislation such as the Finnish Medicines Agency Administrative Regulation 2/2021 and the 437/2021 Decree of the Ministry of Social Affairs and Health. Thus, we will first focus on the Medical Devices Act to explain its content further.
One of the most important aspects of this national regulation is the description of the language requirements applicable in Finland. In this sense, Chapter 2 Section 5 indicates that information and documents according to MDR and IVDR must be in Finnish, Swedish or English.
On the other hand, information necessary for the safe use of a device must be available in Finnish and Swedish. It is up to the manufacturer to determine which information is this. Furthermore, IFUs and labels of single-use devices as per MDR must be in Finnish, Swedish or both "depending on the user's needs" (Finlex, 2021).
Implant card information, as stated in article 18.1.1 MDR, shall be drafted in Finnish, Swedish and English. In contrast, the Declaration of Conformity may appear in English, being option al be also drafted in Finnish and Swedish.
Finally, it may be required by Finnish CA to submit necessary information and documentation in Finnish or Swedish under MDR and IVDR, being the Finnish authorities also competent to order the translation of a notice in a particular language or languages.
Clinical investigation and performance studies' requirements
In Chapter 3, the Finnish MDR & IVDR implementation law sets the need to designate a legal representative if the clinical investigation or performance study is carried out only in Finland, as an EU/EEA country. Nevertheless, the Finnish Competent Authority can grant authorisation to replace the legal representative with a contact person.
The document's applicable language can be Finnish, Swedish or English. Furthermore, Finnish competent authority deadlines for authorisation of clinical investigations and performance studies are mentioned in Sections 21 and 22 of the aforementioned chapter.
Notification of devices
Section 49 of Chapter 5 is one of the most relevant of the Medical Devices Act as it states the different obligations to notify activities and devices to the Finnish Medicines Agency (Fimea) for certain economic operators (further elaborated in the Finnish Medicines Agency Administrative Regulation 2/2021):
- Manufacturers established in Finland;
- Manufacturers of a device for non-medical use as per Annex XVI MDR;
- Manufacturers of custom-made devices, excluding manufacturers of Class III implantable devices;
- Healthcare units engaged in device manufacturing;
- System or procedure pack assemblers;
- Sterilisation service providers that sterilise CE-marked medical devices pursuant to the Directives before they are put into service;
- Authorised representatives;
- Distributors who place on the market IVDs for self-testing or medical devices containing human tissues or substances derived from human blood or plasma;
Thus, they must indicate:
- Operator's name
- Place of business
- Other contact details
- For Manufacturers (including custom-made devices) and importers
- Devices to be placed on the market, their risk class, purpose, operating principle and identification information
- Copy of Notified Body certificate
- Name and business place of authorised representative
- For system or procedure pack assemblers:
- Information on the device, its purpose and identification information
- For sterilisation services providers:
- Sterilisation method used
Other information requirements are also applicable for operators distributing to retailers, healthcare and social welfare operators, professional users, and distributors. The information on the devices distributed by the distributor shall also be up-to-date no later than November 30, 2022.
Plus, the Finnish Medicine Agency charges a variable supervision fee upon the notification of the devices. The amount of the fee depends on the number of devices notified. This supervision fee may double if an operator has neglected its notification obligations. All necessary fees are stated in the 437/2021 Decree of the Ministry of Social Affairs and Health.
The Finnish Medicines Agency Administrative Regulation 2/2021 also provides the notification and registration forms.
In addition to the above, the Medical Devices Act prohibits reprocessing and reusing single-use devices in Finland. Furthermore, Chapter 2 Section 6 states the obligation to only obtain a custom-made device with a prescription from a health care professional.
Moreover, as per section 7 of the Medical Devices Act, it is also important to mention that manufacturers and authorised representatives must provide the technical documentation to Fimea regardless of a bankruptcy or cease of business activity. Additionally, the obligations of economic operators (importers, authorised representatives and distributors) under the MDR and IVDR also apply when placing on the market a medical device fulfilling the requirements of the Medical Device Directive (MDD), the Active Implantable Medical Devices Directive (AIMD) and In Vitro Diagnostic Devices Directive (IVDD).
Finally, Chapter 6 states in section 57 the relevant penal provisions for those placing devices not compliant with the MDR and IVDR regulations. On the other hand, Section 58 institutes the power of the Finnish Medicines Agency to grant exemptions from meeting the regulation requirements for specific devices.
The Medical Devices Act entered into force on July 19, 2021, and is applicable for IVDs from May 26 2022.
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