Regulation serves as a gateway to the global health market. Each organization in the health technology field will have to choose a regulatory strategy according to its target market. The chosen market and strategy will directly influence the depth and scope of product development.
Our regulatory groups at Healthtech Finland support the growth and internationalization of Member companies by providing a common platform for networking, learning together and sharing experiences.
We warmly welcome each new member!
In 2022 we provide regulatory support in three different groups:
- Health software and data (SW+data group), chaired by Mika Siitonen, Labquality
- Medical devices (MD group), chaired by Katja Karhu, Innokas Medical
- In vitro diagnostics (IVD group), chaired by Anja Kontio, Labquality
The group chairs, group secretary Päivi Ahlgren, Technology Industries Finland and group coordinator Sandra Liede, Healthtech Finland are all in attendance during each group meeting.
Software and Data group, spring 2022:
8 February 2022, at 10:00-12:30
29 March 2022, at 10:00-12.30
26 April 2022, at 10:00-12:30
24 May 2022, at 10:00-12:30
MD group, spring 2022:
8 February 2022, at 13:30-16:30
29 March 2022, at 13:30-16:30
26 April 2022, at 13:30-16:30
24 May 2022, at 13:30-16:30
IVD group, spring and autumn 2022:
17 February 2022, at 10:00-12:30
7 April 2022, at 10:00-12:30
9 June 2022, at 10:00-12:30
25 August 2022, at 10:00-12:30
20 October 2022, at 10:00-12:30
8 December 2022, at 10:00-12:30
The schedules of each group meeting will be updated shortly.
Calendar invitations, as well as links to participation, will be sent to each person who has registered on the mailing lists of the working groups. The participation links are also stored on our Member’s website.
The staff of our Member companies are allowed limitless access to regulatory groups simply by registering with one or more of them. For registration, please contact either secretary or coordinator of the regulatory groups.
Content and participation
The main focus of the regulatory groups is on EU legislation, mainly MDR, IVDR, as well as implementing recommendations, guidelines and standards. The regulatory groups also aim to address the market requirements of main exporting countries such as the USA, China and Russia. In addition, the regulatory groups further aim to deepen knowledge in domestic Finnish health regulation and monitor the preparation and implementation of new national legislative initiatives in this area.
Our regulatory groups are open and free of charge for all employees of our Member companies. The groups convene on a monthly basis (excluding summer months). Participation does not require prior preparation. Each participant can choose the amount of time and effort put into the meetings.
Competition law requirements are followed during our regulatory meetings, as we recognize that the meetings are attended by companies operating and competing in the same market or the same distribution chain.
All practices aiming to coordinate business activities or eliminate uncertainty in competitors’ market behavior, and the exchange of confidential information are strictly prohibited during regulatory group meetings.
Companies are required to be fully independent in their business actions. Information less than 12 months old and not available on public sources, and which may have an impact on market behavior, such as pricing, offers or their terms and conditions, shall not be exchanged or discussed in meetings or otherwise between competitors.
Participants of the groups range from new beginners to established experts of the regulatory, quality and product development field in health technology. The regulatory groups are known to have a positive collaborative atmosphere and they have succeeded in uniting experts from large domestic exporters and small start-ups to discuss common regulatory challenges.
Experts from outside of the Association, such as representatives of Competent Authorities or Notified Bodies are also regularly involved in the discussions of the working groups.
Past and future
New regulatory groups may be set up according to the needs and suggestions of the Member companies. The topics are always new and topical, but past themes can also be revisited.
All minutes of the meetings, as well as presentations are stored on our Members’ page to be used by new and old Members.
Person Responsible for Regulatory Compliance (PRRC)
Every manufacturer of a medical device or an IVD device must designate a person responsible for regulatory compliance (PRRC). If the manufacturer is a micro and/or small enterprise, it is sufficient that the undertaking has such a designated person permanently and continuously at its disposal.
Our regulatory groups have jointly reviewed the responsibilities of a PRRC and a model agreement for the free use of Member companies was developed in 2020.