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News and Views June 2017

News and Views May 2017 - Latest Update



In-House Workshops
The "NEW CE" mark
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 to make sure you’re ready to survive and thrive



EVENTS
Meet us!

AACC
August 01-03, 2017
San Diego, USA
Booth: #1941

RAPS
September 09-12, 2017
National Harbor, MD, USA
Booth #537


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MDSS Workshop (IVDR)
August 04, 2017
San Diego, USA
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MDSS Workshops (MDR)

End October, 2017
East Coast, USA




CONTACT

MDSS GmbH
Schiffgraben 41
30175 Hannover
Germany

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

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Consulting


The health care policy in European countries has attracted greater public interest over the last years.  The demand for a healthy life and adequate preventive care as well as optimal medical care in the event of an accident or illness increase the demand for innovative medical devices also due to the higher life expectancy in today’s society.  In the course of these changes, the regulatory requirements bestowed upon medical device manufacturers have increased continuously and become more specified.
 
The Medical Device Directives (90/385/EEC, 93/42/EEC, 98/79/EC) and their transposition into national law (Medical Device Act and regulations) have been revised several times and are the basis for placing on the market of medical devices in Europe.  The guidelines for implementation of the Directives (MEDDEV) and harmonized standards are permanently defined and extended.  The manufacturers must keep in mind all these processes, as well as take into account new or changed requirements, for example, within the scope of the Medical Device Regulation (MDR) and the In-vitro Device Regulation (IVDR).

In the US, access to the market is determined by FDA requirements for medical devices. For decades the so-called Premarket Approval 'PMA' and Premarket Notification '510(k)' procedures have been the determining factors for registration in the U.S. The PMA path has always been required for innovative products. The 'De Novo' procedure, introduced in 1997 and little used for a long time, also offers for such products a possible shortened market access

The consultancy team of MDSS Consulting GmbH offers many years of experience in the interpretation and implementation of regulatory requirements worldwide.  
Thanks to our consulting services, we guide your company safely though the jungle of laws, standards, directives and regulations.