Standards and the state of the art for medical devices regulation
Eamonn Hoxey
![Eamonn Hoxey]()
Eamonn Hoxey
Retired from technical writing, training and consulting - quality & regulatory compliance, sterility assurance, standards development
EU MDCG develop guidance on standardization for medical devices
The Medical Device Coordination Group (MDCG) is composed of representatives of Member States and chaired by the EU Commission. The MDCG has issued a guidance document on standardization for medical devices. As with all the MDCG guidance, it cannot be regarded as reflecting the official position of the European Commission, or as being legally binding.
The guidance covers a range of topics on standardization and the harmonization of standards to provide a presumption of conformity with European regulatory requirements. One interesting area of the document relates to the frequently discussed relationship between standards and the state of the art.
Director Strategic Regulatory Policy Advocacy at Abbott
3 年Hi Eamonn Great to see your post. You are the one who taught me to have an integrated standard management for any good organisation