Conformity Assessments Evaluating medical devices’ compliance with the AMDD would be accompli

Conformity Assessments
Evaluating medical devices’ compliance with the AMDD would be accomplished via conformity assessments, according to a draft of the directive. Conformity assessments would be carried out by member states’ regulatory authorities, and member states would bear responsibility for setting up “appropriate” systems to perform conformity assessments.

It is important to distinguish between AMDD conformity assessments and those used in the European Union. The AMDD does not include analogous routes to conformity assessments as in Annexes II through VII of MDD 93/42/EEC. In addition, the AMDD as drafted does not include significant details on conformity assessments, perhaps as a way to permit markets with robust regulatory systems such as Singapore to continue with its system, which includes abridged market pathways for devices already approved by GHTF member countries and registration exemptions for Class A non-sterile and non-measuring devices.