What is an MDR Gap Analysis?

Until today, medical devices were complying with the Medical Device Directive to sell their products in Europe. However major amendments are made in the current MDD to keep up with the growing technological advances in healthcare and medical devices. The new regulations passed by the Council of the European Union is Medical Device Regulations (MDR) 2017/745 that came into force in May 2017 & manufacturers have a transition time of three years until May 2021 to comply with the new regulations.

An 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 an MDR compliance strategy.

Typically, all MDD-MDR transition projects initiate with Gap Assessment. Gap Assessment is a crucial activity during MDR transition & our team with engineering & regulatory expertise are well equipped to conduct this activity with an analytical mindset, resolve any regulatory concern and develop robust regulatory strategy for medical device manufacturers.

IZiel’s “ONE-STOP COMPLETE SOLUTION” include –

· Gap Assessment

· Technical File Preparation

· QMS Documentation

· Expert Review & Recommendations

· European Authorized Representative (EC REP)

· EUDAMED

· Mock Audits & Trainings

· PRRC Services

· Clinical Evaluation Plan & Report

· Software Validation

IZiel team of specialists and quality professionals look forward to support more medical device companies to file their devices under the MDR 2017/745.