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





RoHS in connection with MDD, AIMDD and IVDD

Status as of October 2013

MDSS has evaluated the RoHS directive and has thought of questions a manufacturer may ask. We also address the answer with the reference to the legal wording of the directive. Nevertheless we have to state that MDSS is not a law firm and provides this information to the best of its knowledge with its professional background as being in the regulated area for many years. However, should you come to any conclusion based on the answers given, please consult the directive or we advise to seek legal counseling.

The RoHS directive applies to (RoHS RL 2011/65/EU Article 4 Paragraph 3):

  • All medical devices placed on the market from July 22, 2014 and falling under the definition of Electrical and Electronic Equipment
  • All IVD products placed on the market from July 22, 2016 and falling under the definition of Electrical and Electronic Equipment

As of today, active implantable medical devices are still excluded from this directive. In case of larger electrical medical devices such as an MRI scanner, it has to be clarified upfront whether this device falls under the term “large-scale fixed installation”, as then the RoHS directive would no longer be applicable.

The compliance with the RoHS Directive can be demonstrated with a technical documentation and EU declaration of conformity according to Annex VI (Directive 2011/65/EU). The technical documentation and the EU declaration of conformity must be kept available for 10 years after the product has been placed on the market.

For further information please contact us.

LINK: RoHS 2011/65/EU
(http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2011:174:0088:0110:en:PDF)

Please click here to access the questions