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 .

DEFINITIONS

What is the definition of

• a medical device?
• an active implantable medical device?
• an in-vitro diagnostic medical device?

How are Advanced Therapies with Gene Therapy, Somatic Cell Therapy and Tissue Engineering regulated within the EU?

How are pharmaceutical products regulated within the EU?

AUTHORIZED REPRESENTATIVE

What is an Authorized Representative and when do you need one?

• Medical Device Directive
• Active Implantable Medical Device Directive
• In-Vitro Diagnostic Directive

What are the regulatory notification requirements for

• my medical device product?
• my active implantable medical device?
• my in-vitro diagnostic?

What needs to be done when an INCIDENT occurs with

• a medical device?
• an active implantable medical device?
• an in-vitro diagnostic?

A product recall (Field Safety Corrective Action) with

• a medical device?
• an active implantable medical device?
• an in-vitro diagnostic?

Removal of products from the market by Competent Authorities?

• Medical Device Directive
• Active Implantable Medical Device Directive
• In-Vitro Diagnostic Directive

Sharing of product information among the Competent Authorities?

• Medical Device Directive
• Active Implantable Medical Device Directive
• In-Vitro Diagnostic Directive

CLINICAL INVESTIGATIONS & PERFORMANCE EVALUATIONS

Overall basic requirements for any clinical investigation or perfomance evaluation?

• Medical Device Directive
• Active Implantable Medical Device Directive
• In-Vitro Diagnostic Directive

Implementation of clinical investigations or performance evaluations

• with a medical device?
• with an active implantable medical device?
• with an in-vitro diagnostic?

• Medical Device Directive
• Active Implantable Medical Device Directive

Identification of european clinical investigators? Leading hospitals in Europe?

Adverse Event reporting requirements in clinical studies?

• Medical Device Directive
• Active Implantable Medical Device Directive

Ethics Committee organization and processes in Europe?

• Medical Device Directive
• Active Implantable Medical Device Directive

Site-specific ethics committees and procedures?

PRODUCT LIABILITY ISSUES

Manufacture product liability exposure and insurance?

• Medical Device Directive
• Active Implantable Medical Device Directive

CLASSIFICATION SCHEME

Medical device risk classification under the MDD?

CONFORMITY ASSESSMENT

Free movement of my product within Europe?

• Medical Device Directive
• Active Implantable Medical Device Directive
• In-Vitro Diagnostic Directive

Essential Requirements for market introduction (Technical, Design Quality Systems, Labeling, Instructions for Use)?

• Medical Device Directive
• Active Implantable Medical Device Directive
• In-Vitro Diagnostic Directive

Conformity Assessment regulatory strategy and application of  Annexes?

• Medical Device Directive
• Active Implantable Medical Device Directive
• In-Vitro Diagnostic Directive

Full Quality Assurance System

• Medical Device Directive
• Active Implantable Medical Device Directive
• In-Vitro Diagnostic Directive

• Medical Device Directive
• Active Implantable Medical Device Directive
• In-Vitro Diagnostic Directive

EC Verification

• Medical Device Directive
• Active Implantable Medical Device Directive
• In-Vitro Diagnostic Directive

Production Quality Assurance

• Medical Device Directive
• Active Implantable Medical Device Directive
• In-Vitro Diagnostic Directive

EC Declaration of Conformity

• Medical Device Directive
• Active Implantable Medical Device Directive (Not Applicable)
• In-Vitro Diagnostic Directive