Regulatory Affairs Associate Interview Questions and Answers

Procedures for variation involve submitting a variation application to regulatory authorities for approval.

• Variation application should include detailed information on the proposed changes

• Regulatory authorities may require supporting data or documentation to support the variation

• Variation procedures may vary depending on the specific regulations and guidelines of the country or region

• Changes to labeling, manufacturing processes, or formulation may require variation applicatio...read more

The main difference between MDD and MDR transition is the increased requirements for medical device manufacturers under MDR.

• MDD (Medical Device Directive) is the previous regulatory framework for medical devices in the EU, while MDR (Medical Device Regulation) is the updated and more stringent regulation.

• MDR introduces new classification rules, stricter post-market surveillance requirements, and enhanced transparency through the EUDAMED database.

• Manufacturers need to comply w...read more

Variations in regulatory submissions include major, minor, and administrative changes.

• Major variations involve significant changes to the product, such as formulation or indication.

• Minor variations are less significant changes, like packaging updates.

• Administrative variations are minor administrative changes, like contact details.

• Examples: Major - adding a new indication, Minor - updating packaging design, Administrative - changing contact information

MDR regulation 2017/245 is a regulation that governs medical devices in the European Union.

• MDR regulation 2017/245 replaces the previous Medical Device Directive (MDD) and Active Implantable Medical Device Directive (AIMDD).

• It introduces new requirements for medical device manufacturers, importers, and distributors.

• The regulation aims to improve patient safety and ensure the quality and performance of medical devices.

• MDR regulation 2017/245 also includes stricter rules for cl...read more