Article 5.3 of the IVDD requires for the high-risk IVDs specified in Annex II, List A, that manufacturers “shall as a general rule be required to comply with the Common Technical Specifications (CTS); if for duly justified reasons manufacturers do not comply with those specifications they must adopt solutions of a level at least equivalent thereto”. 
 
 
The CTS establish appropriate performance evaluation and re-evaluation criteria, batch release criteria, reference methods and reference materials for use in CE marking conformity assessments of IVDs included in Annex II List A.
 
 
As with harmonized standards, compliance with a CTS is not mandatory but it does result in a presumption of conformity with the IVDD Essential Requirements. Manufacturers of IVDs in List A of Annex II must justify any non-compliance with the CTS, and any alternatives must be at least equivalent to those specifications.
 
 
CTS for Annex II List A IVDs have been published in the Official Journal of the European Union - click here for the latest version.
 
 
GEMAR can assist manufacturers in their planning, management and monitoring of performance studies in the compliance with the CTS - contact us for further information.