Compliance & Product Regulatory ApproVals

EU Commission

Proposal for Extension period for MDR/IVDR

 Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL amending Regulations (EU) 2017/745 and (EU) 2017/746 with regard to the  transitional provisions for certain medical devices and in vitro diagnostic medical devices.

The new regulations create a transparent and sustainable regulatory framework which is recognised internationally to ensure quality, safety and performance of devices placed on the EU market.

 The MDR (Medical Device Regulation) has been applicable since 26 May 2021 and the IVDR (In Vitro Diagnostics Regulation) has been applicable since 26 May 2022 in Europe.

EU parliament adopts extension of its transition period in January 2022 as shown below. This applies to devices placed on the market before or during the transition period and still in the supply chain.

 26May 2025 for high risk in vitro diagnostics

26May 2027 for Low risk in vitro diagnostics

26May 2028 for devices manufactured and used in health institution.

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Praveen Rao

CEO & Technical Director, C-PRAV Group: Australia, New Zealand, India & Canada 

C-PRAV Labs & Certifications 

Professional engineering experience of 30+ years with technical and managerial skills obtained from professional degree, courses, and hands-on experience, while working with organizations and companies involved in Design & Development, Testing, Inspection, Certification and Compliance (TICC). 

Management of electrical/electronic products & systems Testing and Certifications for Global markets in Consumer, Industrial, IT, Telecom, Defence, Medical, and Automotive Industries. Overall advisory for Standards, Regulations, Testing and Certifications for Global Market Access (GMA). 

  • ISO/IEC 17025 Lab Quality Management 
  • NATA Authorised Signatory (1995 to 2000) for EMC Testing 
  • NATA & IANZ Authorised Technical Assessor (current)
  • EMI/EMC, RF/Wireless, EMR-RF Exposure/SAR 
  • NATA Technical Assessors Advisory Committee (current) 
  • Current Chair of Australian EMC National Standards Committee 
  • Member of Australian National standards committees for Safety, Radio, RF Exp/SAR 
  • Represent Australia in International Standards committees like IEC, CISPR, IEEE 
  • Member of Telecommunications Certification Body Council, USA and European REDCA