The European Commission has initiated the public consultation on the Draft Implementing Regulation (CIR) and its Annex concerning the common specifications for Class D devices of the In Vitro Devices Regulation 2017/746 (IVDR).
The feedback period on the draft CIR is open from 09 February 2022 until 09 March 2022 via this link!
Scope
The Commission Implementing Regulation divides groups of devices into thirteen Annexes:
• Annex I (General Common Specifications) will apply to devices covered by Annexes II to XIII, as specified in that Annex;
• Annex II will apply to devices intended for detection of blood group antigens in the ABO, Rh, Kell, Duffy, and Kidd blood group systems;
• Annex III will apply to devices intended for detection or quantification of markers of human immunodeficiency virus (HIV) infection;
• Annex IV will apply to devices intended for detection or quantification of markers of human T-cell lymphotropic virus (HTLV) infection;
• Annex V will apply to devices intended for detection or quantification of markers of hepatitis C virus (HCV) infection;
• Annex VI will apply to devices intended for detection or quantification of markers of hepatitis B virus (HBV) infection;
• Annex VII will apply to devices intended for detection or quantification of markers of hepatitis D virus (HDV) infection;
• Annex VIII will apply to devices intended for detection of markers of variant Creutzfeldt-Jakob disease (vCJD);
• Annex IX will apply to devices intended for detection or quantification of markers of cytomegalovirus (CMV) infection;
• Annex X will apply to devices intended for detection or quantification of markers of Epstein-Barr virus infection (EBV);
• Annex XI will apply to devices intended for detection of markers of Treponema pallidum infection;
• Annex XII will apply to devices intended for detection of markers of Trypanosoma cruzi infection;
• Annex XIII will apply to devices intended for the detection or quantification of markers of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection.
Transitional Provisions
The Commission Implementing Regulation envisages the following transitional provisions to give more time to all involved operators:
- For two years from the entry into force of the CIR, devices that conform with the common technical specifications of the Decision 2002/364/EC will be considered in conformity with the requirements of the performance characteristics as laid out in Section 9.1, points (a) and (b), section 9.3 and section 9.4, point (a), of Annex I of the Regulation 2017/746 (IVDR);
- Whereas manufacturers that during this period do not conform with these common technical specifications should be able to provide adequate justification that they have adopted solutions that provide at least an equivalent level of safety and performance;
- For two years from the entry into force of the CIR, the devices that conform with the common specifications as set out in this Regulation, will be considered in conformity with the requirements of the performance characteristics as laid out in Section 9.1, points (a) and (b), section 9.3 and section 9.4, point (a), of Annex I of the Regulation 2017/746 (IVDR).
Next steps: entry Into Force and Applicability
After the public consultation is finalized, the adoption of the Commission Implementing Regulation (CIR) is expected in the First Quarter of 2022. The CIR will enter into force 20 days after its publication in the Official Journal of the European Union.
The CIR will become applicable two years after its entry into force. Apart from Article 3 related to transitional provisions that will start applying at the exact moment as the CIR enters into force.
You can find the CIR and other documents in our dedicated Library.
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