Document xzp3dd46w199p33KDvydpk2G

sector". It is noticeable that SEAC did not refer, or limit, to Directive 93/42/EEC in relation to this time-limited exemption. 4. The compiled RAC-SEAC opinion, page 39, shows that following the public consultation on the Annex XV report, the Dossier Submitter proposed derogation for medical devices until 2020, and for implantable cardiovascular devices until 2030. Again, no reference, or limitation, to Directive 93/42/EEC. This is confirmed in the final Background Document. 5. When the proposal was tabled for discussion in the REACH Committee meeting of October 2016, the Commission's draft text foresaw the exemptions in the same wording as finally adopted, with the reference to Directive 93/42/EEC included. The Detailed Explanation prepared by the Commission in accordance with Article 73(1) stated that "the Commission proposes simply to apply the longer deferral to all nonimplantable medical devices". 6. Recital (6) of Regulation 2017/1000 refers to SEAC suggesting longer deferrals of the restriction for, inter alia, non-implantable medical devices, without further qualification. Based on all the above, we understand the exemption of point 3(c), which was suggested at a later stage than that of point 4(d)(i), as applying to all medical devices that are not exempted under point 4(d)(i), and that the wording "medical devices other than implantable medical devices within the scope of Directive 93/42/EEC" in point 3(c) covers all medical devices that are not "implantable medical devices within the scope of Directive 93/42/EEC" mentioned under point 4(d)(i), regardless in which directive's scope they fall. We hope you find this explanation useful. Best Regards, European Commission DG Internal Market, Industry, Entrepreneurship and SMEs From: Sent: Tuesday, May 5, 2020 2:42 PM To: GROW D1 Cc: Subject: Bilateral request for clarification purposes - RE: DIAsource Immunoassays -