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Update to IVD Directive


Please note the IVD Directive 98/79/EC and Common Technical Specifications have been amended.

Variant Creutzfeldt-Jakob disease (vCJD) assays for blood screening, diagnosis and confirmation are now classed as an "Annex II - List A" device. With this, manufacturers must follow a higher order conformity assessment procedure involving a notified body before the CE mark is affixed to the device. (In most cases, Annex IV including sections 4 & 6). As per Annex IV, section 3 is NOT sufficient. The Common Technical Specifications (CTS) have also been amended accordingly.

 

Both amendments can be found at the following links:

 

 

 

  • COMMISSION DIRECTIVE 2011/100/EU of 20 December 2011 amending Directive 98/79/EC of the European Parliament and of the Council on in-vitro diagnostic medical devices

          http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2011:341:0050:0051:EN:PDF

 

  • COMMISSION DECISION 2011/869 of December 2011 amending Decision 2002/364/EC on common technical specifications for in-vitro diagnostic medical devices
         http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2011:341:0063:0064:EN:PDF

For further information on this topic please feel free to contact us diretcly:

Medical Device Safety Service GmbH
Schiffgraben 41
30175 Hannover
Germany

Phone: +49 511 6262 8630
Fax: +49 511 6262 8633


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