Finland may not be a colossal trade partner of the United States, but as a European Union (EU) member it’s part of the long-standing most attractive export market for the US medical device companies.
And Finland is captivating in itself. It ranks high in European healthcare system comparison and in the digital performance of EU Member States in 2021 Digital Economy and Society Index (DESI). There’s a strong demand for high-quality and high-tech medical solutions in Finland.
So how can US medtech companies bring their devices to the Finnish market? Of course there’ll be regulatory hurdles, but what to expect?
I’m going to provide answers to 10 questions that’ll help US medical device organizations understand better how to access the Finnish market.
1. What medical device regulations apply in Finland?
The main regulation comes from the EU. The Medical Devices Regulation (EU) 2017/745 (in short, the MDR) applies to all EU Member States, including Finland. The benefit is the Single Market concept: basically any medical device that is in compliance with the MDR and carries a CE mark, can be sold in any EU country, such as Finland.
Device manufacturers need to also pay attention to Finland’s national legislation. The MDR gives some leeway on implementing the regulation on a Member State level. In Finland’s case it means that in addition to the MDR, device manufacturers need to follow Finnish medical device legislation:
- Medical Devices Act 719/2021 (at the time of writing available only in Finnish)
- Finnish Medicines Agency Administrative Regulation – Operator and device register notifications related to medical devices to the authorities (Fimea 2/2021)
In addition to medical device laws, it’s good to keep in mind other EU or Finnish legislation that may apply to the device in question. For example, RoHS Directive affects electrical and electronic equipment in the whole EU, while Radiation Act (859/2018) impacts radiation emitting devices used in Finland.
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2. What are the provisions of the Finnish national medical device legislation?
Some of the most relevant provisions from a US manufacturer’s point of view are:
- Single-use medical devices are not allowed to be re-processed or re-used in Finland
- The language requirements
- Information required for the safe use of the device – Finnish and Swedish
- Other information provided with the device – Finnish, Swedish or English
- Information provided with a device intended for patients or consumers – Finnish and Swedish
- Custom-made device IFU and labels – Finnish and/or Swedish
- Information on the implant card – Finnish, Swedish and English
- Clinical investigation application – Finnish, Swedish or English
- Exceptions: summary of the clinical investigation plan, informed consent process description and documents used to obtain informed consent – Finnish or Swedish
- Finnish Competent Authority Fimea may request a copy of authorized representative mandate in Finnish or Swedish
- Fimea may request the manufacturer to provide all the information and documentation necessary to demonstrate the conformity of the device in Finnish or Swedish
- Fimea may impose national administrative regulation regarding
- the professional qualifications of a person responsible for regulatory compliance and of the person who can prescribe a custom-made device
- the manufacturer’s or authorized representative’s obligation to keep certain documents at the disposal of the competent authority
- the procedures to be applied in marketing medical devices in Finland
- the creation and content of clinical investigation reports
- Marketing medical devices to consumers must take Finnish Consumer Protection Act 38/1978 into account
- Manufacturers planning to conduct a clinical trial in Finland must apply for a permit or inform Fimea and also get approval from ethics committee beforehand
- Fimea decides if a sponsor can use a contact person instead of a legal representative in clinical investigations in Finland
- Distributors who distribute medical devices to retailers or professional users in Finland must register their organizations and their devices with Fimea and pay a fee.
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3. How similar or different is the medical device classification system in Finland when compared to the US FDA’s classification system?
In both markets medical devices are divided into three classes based on risk: I, II and III.
However, due to the MDR, risk classes I and II in the EU (and therefore in Finland) are further subdivided as follows:
- Class I – Class Is is for sterile devices, Im is for measuring devices and Ir is for reusable surgical instruments. The other class I devices are the lowest risk devices. These include those that are non-sterile, non-measuring and not reusable surgical instruments.
- Class II – Class IIa is for medical devices with low to medium-risk, and IIb is for medium- to high-risk devices.
- Class III is for the highest risk devices and similar to the US system, are subject to the most regulatory oversight.
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4. How does the medical device risk classification affect the medical device market approval process in Finland?
A quick terminology note first: In the EU (and therefore in Finland) the medical device market approval process is called conformity assessment.
For class I devices, the manufacturer conducts the conformity assessment unless the devices
- are placed on the market in sterile condition,
- have a measuring function, or
- are reusable surgical instruments.
In those cases, the manufacturer carries out most of the conformity assessment. However in the areas of sterility, measuring and reusability, the assessment is conducted by an external organization called a notified body.
Notified bodies conduct the entire conformity assessment for class II and III devices.
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5. Is Finland’s medical device conformity assessment process centralized?
No, unlike the FDA’s preclearance process in the US, Finland’s conformity assessment process is decentralized as many of the requirements are part of the EU’s regulatory scheme.
There are many players in the process. The highest one is the EU Commission. It proposes and enforces the EU legislation (such as the MDR) and directs the EU’s administrative operations. Other significant players are the EU Member States with their national government agencies (competent authorities – Fimea in Finland) and private commercial companies (notified bodies).
There are several notified bodies across the EU countries. A manufacturer can apply to any of them for a conformity assessment as long as the notified body has been designated to assess the device scope relevant to the manufacturer’s device.
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6. How long will the conformity assessment by a notified body take?
Currently there is a shortage of notified bodies designated under the MDR. In addition, the ones that have already been designated are extremely busy. Getting your organization into a notified body’s queue and getting to the front of the queue can take a long time. Unlike the US system with 510(k)s, there is no review clock for the conformity assessments conducted by the notified bodies under the MDR.
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7. How long is the conformity assessment approval valid?
Since the manufacturers of class l devices self-declare the conformity of their devices, the approval lasts until the manufacturer determines that a significant change has taken place. Then the manufacturer reassesses the approval, updates relevant parts of the conformity, and issues a new declaration of conformity when the requirements have been met.
If the device conformity needs to be partly or fully assessed and approved by a notified body, the conformity assessment certification is fixed term. It has to be renewed before it expires. Also, whenever a significant change is made to the device, a notified body needs to review it and possibly conduct a new conformity assessment.
Additionally, conformity assessment approval has to be reassessed and renewed when the EU medical device regulation changes.
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8. Can a US manufacturer sell their device directly to Finnish customers?
No. First the US manufacturer must appoint an authorized representative. Then, the US manufacturer needs an importer, and possibly a distributor too.
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9. What is an authorized representative and where can you get one?
An authorized representative is a person who lives in the EU or a company that has its business registered in the EU. The individual or firm needs to have received and accepted a written mandate from a manufacturer, located outside the EU, to act on the manufacturer’s behalf. The authorized representative performs the tasks that are specified in the mandate. An authorized representative should be someone the manufacturer can trust to act as its legal representative in the EU.
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10. What are the steps in bringing a US medical device to the Finnish market?
If the device in question is not MDR compliant nor CE marked yet, then the organization should go through all the following steps:
- Read the applicable medical device regulatory controls in the MDR (Regulation (EU) 2017/745) including:
- Device classification rules
- Manufacturer’s obligations
- Conformity assessment route options
- Essential device requirements
- Create a regulatory strategy for the Finnish market (MDR + Finnish national legislation)
- Classify the medical device
- Choose the applicable conformity assessment route
- Fulfill the manufacturer’s legal obligations (e.g. QMS, technical documentation)
- Appoint person responsible for regulatory compliance, authorized representative and importer (possibly distributor too)
- Set up a UDI system and assign UDIs to the devices
- Carry out the conformity assessment (by the manufacturer and/or notified body)
- After the conformity assessment has been approved by the manufacturer and/or notified body, create an EU declaration of conformity and attach a CE mark to the devices
- Register the organization and the devices in the EU Commission database Eudamed
- Instruct your authorized representative and importer to register in Eudamed and the potential distributor with Fimea.
If the US organization’s medical device is MDR compliant and CE marked before entering the Finnish market, only the national legislation requirement needs to be considered and implemented.
This article attempted to answer key questions that US medical device organizations might be asking when they explore the opportunity of selling their devices in Finland. If you’d like to know more or have any questions, please contact me.