SGS Fimko Oy is designated as Notified Body for Medical Device Regulation (EU) 2017/745 by the Finnish competent authority FIMEA.
Download Notification by Finnish Medicins Agency
The notification includes following conformity assessment routes (regulation (eu) 2017/745 on medical devices – MDR):
- Annex X
- Annex IX(I)
- Annex IX(II)
- Annex XI(A)
- Annex XI(B)
SGS Fimko Oy can provide this service for medical devices up to class llb respectively for software up to class lll.
Together with our Notified Body SGS Fimko Oy we offer this service in Germany.