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THE "NEW" CE MARKING
Get your questions answered for the NEW MD REGULATION – THE MDR!!!
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EVENTS
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MEDICA
November 13-16, 2017
Düsseldorf, Germany
Booth #10B05



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

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

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CONTACT

MDSS GmbH
Schiffgraben 41
30175 Hannover
Germany

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

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News and 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.

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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:

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