MDR requirements for GAP analysis.

This free tool, developed by Regulatory Globe, is intended to help medical device companies in the transition process of implementing the new European Medical Device Regulations by offering a simplified way to understand, assess and execute necessary changes required for compliance.

This tool will help to:

1. Understand which requirements really affect our company

2. Identify gap areas that must be updated for compliance

3. Learn how to implement the new EU MDR requirements

4. Customize our analysis based on the specific functions within our organization

An EU MDR Gap Analysis is the process of systematically examining a medical device’s clinical evidence portfolio to determine whether it demonstrates conformity with all relevant MDR requirements. It is a crucial first step in developing and maintaining a compliance strategy of MDRSAP consulting firms.

Discuss our MDR requirements with a member of our expert medical team. Performing an MDR Gap Analysis is essential when transitioning a device’s regulatory framework from the out-going Medical Device Directive (MDD) to the new Medical Device Strategy Consulting Regulation (MDR) 2017/745. Undertaking an MDR Gap Analysis will enable the identification of any gaps in the clinical evidence portfolio, allowing measures to be taken to address these gaps before engaging a regulatory body.

Performing an MDR Gap Analysis correctly requires:

• a thorough understanding of the MDR, especially the Annex I General Safety and Performance Requirements

• the ability to search, assimilate and critically appraise clinical evidence

• the capability to make recommendations for addressing any gaps identified.

For more details on this, please browse www.mdrconsultants.com.