MDSS EUROPEAN AUTHORIZED REPRESENTATIVE SERVICES MDSS CONSULTING   ENGLISH    GERMAN    CHINESE
News Updates
    
HIGHLIGHTS
Keep up to date!

THE "NEW" CE MARKING
Get your questions answered for the NEW MD REGULATION – THE MDR!!!
more...


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



EVENTS
Meet us!

MEDICA
November 13-16, 2017
Düsseldorf, Germany
Booth #10B05



Join us!

9. Medical Device Networking Meeting - 
a RAPS Roadshow
November 30, 2017
Hannover, Germany

more...

10. Medical Device Networking Meeting - 
a RAPS Roadshow 
December 04, 2017
Ulm, Germany

more...



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 MEDDEV Guidelines


Please use the following links and you will automatically directed to the pdf document:


1) MEDDEV 2.1/6 Qualification and Classification of stand alone software (posted by MDSS January 2012)

http://ec.europa.eu/health/medical-devices/files/meddev/2_1_6_ol_en.pdf


2) MEDDEV 2.2/4 Conformity assessment of In Vitro Fertilisation (IVF) and Assisted Reproduction Technologies (ART) products (posted by MDSS January 2012)

http://ec.europa.eu/health/medical-devices/files/meddev/2_2_4_ol_en.pdf


3) MEDDEV 2.12/2 rev.2 Post Market Clinical Follow-up studies (posted by MDSS January 2012)

http://ec.europa.eu/health/medical-devices/files/meddev/2_12_2_ol_en.pdf


4) MEDDEV 2.5/10 Guideline for Authorized Representatives (posted by MDSS February 2012)

http://ec.europa.eu/health/medical-devices/files/meddev/2_5_10_ol_en.pd


5) MEDDEV 2.14/4 CE marking of blood based in vitro diagnostic medical devices for vCJD based on detection of abnormal PrP (posted by MDSS February 2012)

http://ec.europa.eu/health/medical-devices/files/meddev/2_14_4_ol_en.pdf


6) MEDDEV 2.14/1 rev.2 Borderline and Classification issues. A guide for manufacturers and notified bodies (posted by MDSS February 2012)
http://ec.europa.eu/health/medical-devices/files/meddev/2_14_1_rev2_ol_en.pdf



7) MEDDEV 2.12-1 rev.7 Guideline for a Medical Devices Vigilance System (posted by MDSS March 2012)

http://ec.europa.eu/health/medical-devices/files/meddev/2_12_1_ol_en.pdf



For further information please visit the website of the European Comssion

http://ec.europa.eu/health/medical-devices/documents/guidelines/index_en.htm

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