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Key addresses for basic information

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 system, classification, etc

CAMD Competent authorities for Medical Devices – Information new MDR.

Notified Body Recommendation documents relative to the Medical Regulations The Recommendations \"NB-MED\" are issued by the European association of Notified Bodies for Medical Devices (including IVD’s). They translate the Regulation requirements into practical guidelines and take positions concerning some grey areas.

Harmonized Standards for Medical Devices:.

Harmonized Standards for IVDs:.

List of contact points within the EU national competent authorities.

List of Vigilance contact points within the European Competent Authorities:

Official journal of the European Communities:

MHRA Competent Authority for United Kingdom:

ANSM: French Drug and Medical Agency:

Standards: Looking for British, European or international standards? British Standards Online is the exclusive, authoritative, and most current site for all publications from BSI.

[http://www.medtecheurope.org/ ] The European Diagnostic & Medical Devices Manufacturer Association

EUDAMED Information Center: Find answers to your questions for Manufacturer registration, Product registration and other upcoming modules

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