MediMark Europe has selected very helpful links for finding easily the updated official European regulatory documents and to feed some other regulatory needs.
-* MD & IVD Regulations : This site from the European Commission gives you the integral texts of the MD & IVD Regulations and much more. MEDDEV Guidelines for MDs & IVDs: : See GUIDANCE section. You will find the updated MEDDEV guidance and informative documents from the European Commission concerning the vigilance (…)
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Key addresses for basic information
24 June 2023, by Rene Clement -
Searching for a NANDO designated NB ?
27 May 2020, by MMENANDO is publishing a list of NBs designated for MDR and IVDR auditing.
Lists are available from EUROPA (GROWTH) website and permanently updated. Here below are the useful e-address where to start your researches.
NANDO is publishing a list of NBs designated for MDR and IVDR
(with or without "restrictions" in their fields)
MDR list is available from https://ec.europa.eu/growth/tools-d...
Clicking on one the 14 (on May 27 2020) existing NB, you’ll access to their contact (…) -
January 2020 MIR form rev 7.2 and its Annexes
5 January 2020, by MMEStarting January 01, 2020, the management of vigilance event made the use of a new form compulsory, which is so far MIR rev. 7.2.
And to use it, publishing was made too of an updated "Help Text" (list of Annexes A to F codes)
Starting January 01, 2020, the management of vigilance event made the use of a new form compulsory, which is so far MIR rev. 7.2.
As EUDAMED has been delayed, some sections are not yet available and are either prefilled (with "unknown") or left blank (…)