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News and Views June 2017

News and Views May 2017 - Latest Update

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News and Views

MDSS Newsletter and News

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.


Please find below the most recent Newsletter:

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

News and Views August 2016

News and Views June 2016

News and Views May 2016

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



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