E-ssentials medical devices, Edition 1, February 2017
Dr Peter Havel: What's new in 2017?
A clever move to combat counterfeiting: TÜV SÜD registers “CE 0123” as EU Trademark
To combat counterfeiting and product piracy, TÜV SÜD has now registered the CE marking with the company’s CE identification number “CE 0123” as EU Trademark and has created an effective weapon against irresponsible counterfeiters.
Ensure transparency and compliance in advertising with TÜV SÜD certification marks
The TÜV SÜD certification mark has recently been adjusted to ensure compliance with the latest court rulings. The change was initiated by a verdict of June 21, 2016, of the German Federal Court of Justice which confirmed B2C advertising that uses certification marks without providing further information about the underlying tests to be unacceptable.
Health Canada will terminate the CMDCAS program on December 31, 2018. After this date Health Canada will only accept MDSAP certificates from manufacturers with their device applications or renewals. To facilitate uninterrupted market access TÜV SÜD will no longer be conducting CMDCAS audits as of September 30, 2017.
IEC 60601-1:2005: End of transition periods of the Amendment 1:2012
From 2018, the Amendment 1 to IEC 60601-1 3rd edition applies for the production of electrical medical devices that are supposed to be marketed in the EU. A transition period until December 31, 2017, was defined. The oncoming end of transition reminds to deal with the changed requirements as soon as possible.