Contents
THE EUROPEAN COMMISSION,Having regard to the Treaty on the Functioning of the European Union,Having regard to Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EECnote, and in particular Article 61(8) thereof,Whereas:
(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,
HAS ADOPTED THIS REGULATION:
Article 1#
In Article 61(6) of Regulation (EU) 2017/745, point (b) is replaced by the following:
(b)for which the clinical evaluation is based on sufficient clinical data and is in compliance with the relevant product-specific CS, where such a CS is available and that are one of the following:
(a)sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips, connectors,
(b)cranial perforators, cranio-blades, catheter passers, patties and strips, magnets for implantable pulse generators, port plugs, stylets and stylet guides, needles, needle holders, forceps, cannulas, atrioseptostomy balloon catheters, catheters coated with anticoagulants, blood bags incorporating anticoagulants, port catheters, introducers, dilators, ventricular drains, feeding tubes, suture pledgets, suture sleeves, suture buttons, gastrostomy buttons, bone tacks, bone wax, bone fillers, bone substitutes, stem centralisers, diaphyseal obturators, radiography markers, fiber ligatures, tubal extraluminal ligation devices, transpalatal distractors, nails, anchors, spinal posterior fixations, textile braids, dental implants, orthodontic devices, dental barriers, dental veneers, suspensory fixations and cinches, reusable surgical instruments, springs for skull enlargement, guidewires, pressure wires, pacing wires and leads, snares, lead caps, fixation and connector tools, endovascular embolisation coils, embolisation particles, cables, shunts and internal defibrillation paddles.’.
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