(fra kommisjonsforordningen) 

(1) In accordance with Regulation (EU) 2017/745, the Commission may amend the list of types of class IIb implantable devices which are exempted from the obligation to perform an assessment of the technical documentation for every device in the course of the conformity assessment procedure. 

(2) Experience with the application of Regulation (EU) 2017/745 has demonstrated that in addition to the types of class IIb implantable devices listed in Article 52(4), second subparagraph, of Regulation (EU) 2017/745, several other types of class IIb implantable devices also meet the criteria to be considered well-established since they have common, simple and stable design; they have well-known safety and they have not been associated with safety issues in the past; they have well-known clinical performance characteristics and they are standard of care devices with little evolution in indications and the state of the art; and they have a long history on the Union market. 

(3) The list of types of class IIb implantable devices set out in Article 52(4) should therefore be amended to include other well-established technologies. 

(4) In order to determine which well-established technologies are to be added to the list of implantable devices set out in Article 52(4) of Regulation (EU) 2017/745, the Commission undertook a wide consultation of the Medical Device Coordination Group. (5) Regulation (EU) 2017/745 should therefore be amended accordingly,