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News and Views

Visit our new website for the latest News & Views!


As a service for our clients MDSS will inform you about the latest news, views and developments.
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 Newsletter: 

News and Views November 2018 - Update

News and Views November 2018

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

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 to Portuguese Registration

Update to MEDDEV Guidelines

IVD Directive 98/79/EC and Common Technical Specification

Borderline manual

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