MDSS EUROPEAN AUTHORIZED REPRESENTATIVE SERVICES MDSS CONSULTING   ENGLISH    GERMAN    CHINESE
News Updates
  • Looking for a suitable GMDN-Code?
    MDSS can assist you to determine an appropriate code for your products!
    more


  • MDSS, may support you with the process of applying for a Free Sales Certificate/Certificate of Marketability...more


    
HIGHLIGHTS
Keep up to date!

News and Views June 2017

News and Views May 2017 - Latest Update



In-House Workshops
The "NEW CE" mark
Book now!
 to make sure you’re ready to survive and thrive



EVENTS
Meet us!

AACC
August 01-03, 2017
San Diego, USA
Booth: #1941

RAPS
September 09-12, 2017
National Harbor, MD, USA
Booth #537


Join us!

MDSS Workshop (IVDR)
August 04, 2017
San Diego, USA
Read more...


MDSS Workshops (MDR)

End October, 2017
East Coast, USA




CONTACT

MDSS GmbH
Schiffgraben 41
30175 Hannover
Germany

Phone
(+49)-511-6262 8630
FAX
(+49) -511-6262 8633

Click here to
contact us





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


Or Click Here for our Contact Form