02. Februar 2019
UK Government is prepared to introduce its own conformity mark in case of the Brexit that will be replacement of the CE-marking used within the EU.

29. Januar 2019
MDCG today published another guidance explaining more details on the Basic UDI-DI that will be relevant for the EUDAMED Database Manufacturer's Declaration of Conformity And the Technical Documentation MDCG 2019-1 MDCG guiding principles for issuing entities rules on Basic UDI-DI The core information included is: The Basic UDI-DI code value shall have maximum 25 characters A check digit/character must be part of the Basic UDI-DI Further guidance concerning the UDI was already published by MDCG...

21. Januar 2019
The start to an operational MDR.

01. Dezember 2018
Australian TGA reclassifies the surgical mesh products from IIb to Class III

20. November 2018
The EU Commission previously published the factsheet for EU based medical device Manufacturers that is now amended by two further factsheets for Non EU Authorities and economic operators.

01. November 2018
Update of the Borderline Products Guidance issued by the EU-Commission introducing 5 new borderline products.

10. Oktober 2018
5 new guidance documents concerning the implementation of the UDI in Europe published by MDCG

06. September 2018
DEKRA and SGS became fully recognized MDSAP audition Organizations.

01. September 2018
As of September 1st 2018 the new name of the organization responsible for Medical devices in China is "National Medical products Administration" (NMPA) replacing the former China Food and Drug Administration (CFDA). The new website www.nmpa.gov.cn of the administration now active. NMPA is an organization under the "State Administration for Market Regulation" (SAMR) that was found in March 2018 integrating the former: State Administration for industry and commerce of the PRC (SAIC) General...

27. August 2018
A notice published by ISO indicates that the FDA may be considering to replace the Current Quality System requirements (as published under 21CFR820) by the ISO 13485 already in 2019. This would create a further step to the global harmonization....

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