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null Is your innovation a medical device? How will your innovation translate into a product? Have a look at Valvira’s new info graphs

Is your innovation a medical device? How will your innovation translate into a product? Have a look at Valvira’s new info graphs

30.11.2017 10:51 / News

Is your health technology innovation a medical device? How will your innovation translate into a product complying with statutory requirements? Valvira’s new info graphs help enterprises identify medical devices and develop their innovations into successful products.

Regulations and monitoring promote safety. In order to be successful, a product must be safe. Medical devices brought to market must comply with the relevant legislation. For instance, the manufacturer must issue a declaration of conformity and attach a CE marking to the product as proof of conformity. In order for a product to be accepted as a medical device, the manufacturer must show that its purpose falls within the definitions given in legislation. Legislation regulating medical devices is partly EU legislation and partly national legislation. European-level legislation will be further harmonised in the near future as new EU Regulations replace current legislation after their respective transition periods, barring exceptions provided for by national legislation.

Valvira is a participant in the Slush fringe event “Health and welfare services meets startups” on Thursday 30 Nov. You can follow the event by live stream (11.30–14.30), on Facebook or on Twitter with the hashtag #soteSlush. Valvira is also a participant in the Slush Y Science event on Friday 1 Dec.


Read more:

Is my brilliant healthtech innovation a medical device? (pdf)

From Innovation to Product (pdf)

Bringing a product to market (in Finnish) (Valvira.fi)

Information on Regulations applying to medical devices (in Finnish) (Valvira.fi)

Valvira becomes the competent authority for medical devices and notified bodies as of 26 Nov 2017

EU Regulations on medical devices enter into force today (in Finnish) (26 May 2017)

Further information:

Antti Härkönen, Senior Officer
Tel. +358 (0)295 209 530

Nelli Karhu, Senior Officer
Tel. +358 (0)295 209 385

firstname.lastname@valvira.fi