(fra kommisjonsforordningen)

(1) In accordance with Regulation (EU) 2017/745, the Commission may amend the list of implantable devices and class III devices which are exempted from the obligation to perform clinical investigations. 

(2) Experience with the application of Regulation (EU) 2017/745 has demonstrated that in addition to the types of implantable devices and class III devices listed in Article 61(6), point (b), of Regulation (EU) 2017/745, several other types of implantable devices and class III 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 implantable devices and class III devices set out in Article 61(6), point (b), 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 and class III devices set out in Article 61(6), point (b), of Regulation (EU) 2017/745, the Commission undertook a wide consultation of the Medical Device Coordination Group. 

(5) Although manufacturers are exempted from the obligation to perform clinical investigations for the types of implantable devices and class III devices listed in this Regulation, they are nonetheless required to plan, conduct and document a clinical evaluation in accordance with Article 61 of Regulation (EU) 2017/745 for those devices. 

(6) Regulation (EU) 2017/745 should therefore be amended accordingly