MDD to MDR

MDD refers to the Medical Devices Directive (the Council Directive 93/42/EEC of 14 June 1993 on medical devices last amended by Directive 2007/47/EC), a collection of legislations laid down by the European Commission on medical devices. Medical Device manufacturers must comply with MDD to receive CE Approvals and thereby authorized to sell the products in Europe.

However, the MDD has undergone a major revision and the new regulation MDR–Medical Device Regulation 2017/745 will soon replace MDD. MDD-MDR must be implemented from May 2020.

IZiel has collaborated with regulatory experts in Europe & US to resolve all queries and provide a complete solution from MDD-MDR to get CE Approvals.

Major Changes – MDD-MDR

IZIEL-OBELIS Collaboration

Together, Obelis & IZiel formed a partnership to create a “one-stop shop” to fully support Class I, IIa, IIb & III medical device manufacturers across USA, Europe & Asia to obtain conformity with the MDR (2017/745) requirements and maintain their CE Marking – this, through technical support, consultancy, representation and device registration services.

Obelis is currently representing over 3000 exporters from more than 60 countries around the world.

ONE-STOP COMPLETE SOLUTION include –

– Gap Assessment

– Prepare Technical File

– Prepare & Implement QMS Documentation

– European Regulatory Expert Review & Recommendations

– European Authorized Representative (EC REP)

– EUDAMED

– Mock Audits & Trainings

– PRRC Services

– CEP & CER

– Software Validation