MDSS EUROPEAN AUTHORIZED REPRESENTATIVE SERVICES MDSS CONSULTING   ENGLISH    GERMAN    CHINESE

Get a Quote from MDSS Your Authorized Representative forMedical Devices and In Vitro Diagnostic Devices

News Updates
  • Looking for a suitable GMDN-Code?
    MDSS can assist you to determine an appropriate code for your products!
    more


  • Have MDSS, your Authorized Representative, apply for a Free Sales Certificate/Certificate of Marketability on your behalf!
    more


    
HIGHLIGHTS
"The NEW CE MARKING"
Get your questions answered for the NEW REGULATION
– THE MDR/IVDR!!!

more...


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


Keep up to date!

Cosmetic Products in Europe

Latest News



EVENTS
Join us!

International
MDR Happening

December 11-12, 2018
Hannover, Germany



Meet us!

Arab Health
January 28-31, 2019
Dubai

SE-Asian Healthcare & Pharma Show
April 9-11, 2019
Kuala Lumpur






Contact MDSS

MDSS GmbH
Schiffgraben 41
30175 Hannover
Germany

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

Click here to
contact us





News and Views

The Newsletter will be sent out by MDSS periodically, depending in the recent changes in the regulatory world. 

Click here to sign up for our Newsletter notices



Please find below the most recent Newsletters:

News and Views July 2018

News and Views January 2018


News and Views October 2017

News and Views June 2017

News and Views May 2017 - LATEST UPDATE

News and Views May 2017

News and Views March 2017

News and Views February 2017

 

Please use the following link to have a look at previous News and Views:

Archive




Further News:

 

- New lists of harmonized standards for MDD, AIMDD, IVD, 10 July 2015 in the Official Journal of the EU:

- New lists of harmonized standards

- Updated Harmonized Standards for Medical Devices, In-Vitro Diagnostica and Active Implantable Medical devices

- Update on Vigilance Guideline MEDDEV 2.12-1 Revision 8

- European CE IVD & Medical Device Regulations

- Update Portuguese Registration

- Update to MEDDEV Guidelines

- IVD Directive 98/79/EC and Common Technical Specification

- Borderline manual

- Italian Ministry of Health abolished 100€ fee

- Update on National Drug and Health Products Safety Agency

- Regulation on cosmetic products (1223/2009/EC)

- The European Commission has issued a recommendation on a common framework for a unique device identification system (UDI) for medical devices in the European Union (April 2013).

- Starting July 1, 2013, Croatia is an official member of the European Union

- Manual on borderline and classification in the community regulatory framework for medical devices (06-2013)

- Update Harmonized Standards: EN 980 is back

- Changes of the regulations of medical devices in Germany

- Agreement on new medical devices regulation shall be reached this autumn