Frequently Asked Questions (and the links to the Answers)
Within our commitment to optimize the presentation and utility of the critical public knowledge regulatory information presented, we welcome all comments, suggestions and questions from clients and colleagues .
COMPETENT AUTHORITIES & NOTIFIED BODIES
Competent Authorities througout Europe - Who to contact? phone, e-mail, addresses, weblinks
Which Notified Bodies are available for consultation concerning
What is the definition of
What is an Authorized Representative and when do you need one?
What are the regulatory notification requirements for
What needs to be done when an INCIDENT occurs with
A product recall (Field Safety Corrective Action) with
Removal of products from the market by Competent Authorities?
Sharing of product information among the Competent Authorities?
CLINICAL INVESTIGATIONS & PERFORMANCE EVALUATIONS
Overall basic requirements for any clinical investigation or perfomance evaluation?
Implementation of clinical investigations or performance evaluations
Adverse Event reporting requirements in clinical studies?
Ethics Committee organization and processes in Europe?
PRODUCT LIABILITY ISSUES
Manufacture product liability exposure and insurance?
Free movement of my product within Europe?
Essential Requirements for market introduction (Technical, Design Quality Systems, Labeling, Instructions for Use)?
Conformity Assessment regulatory strategy and application of Annexes?
Full Quality Assurance System
Production Quality Assurance
EC Declaration of Conformity