Qepler | summits & conferences | Medical Device Regulations Summit, 22-23 September 2021
Event Location:
Prague, Czech Republic
Novotel Praha Wenceslas Square Hotel Katerinska 1476/38
22 September 2021 - 23 September 2021

Early Bird discounts:
Register early to save € 500 for the Individual ticket, € 600 per person for 2-3 Delegates, € 700 per person for 4+ delegates from the same company until 16 April 2021.

Conference Overview

Medical Device Regulations Summit 2020 is focusing on EU MDR and IVDR overview, appropriate challenges and strategies for their overcome; company, team and portfolio preparation to new regulations; technical documentation, labelling and clinical data adoption; risk management and quality management systems updates; compliance strategies; Unique Device Identification (UDI) system implementation; medical devices traceability and devices classification.

The featured talks on

  • EU MDR overview - main regulation changes, challenges you will meet during transition and strategies for their overcome.
  • Expansion of indications for a medical device -- what are all things that have to be considered to be successful.
  • Switching to the EU Medical Device Regulation. Preparing company to meet the Medical Device Regulation (MDR).
  • MDR transition – preparing your company and team. Adopting your technical documentation, labelling and clinical data to EU MDR. Process and conformity assessment.
  • Practical case study - Steps of the successful EU MDR implementation.
  • Adopting current medical devices portfolio to EU Medical Device Regulation.
  • Risk management transformation and new safety measures. In-depth clinical data assurance. EU MDR and MD risk management – implementation challenges overcome.
  • Medical devices reassessment for compliance and certification.
  • Revisiting your QA, risk management and post-market vigilance.
  • Updating quality management system to MDR. Key elements.
  • Unique Device Identification (UDI) system implementation for device tracking throughout the supply chain. Labelling. Post market requirements.
  • Medical Devices traceability requirements.
  • Medical devices reclassification based on new requirements. New classification rules.
  • MDR and IVDR. In vitro diagnostics classification.
  • Drug device combination products safety.
  • Biocompatibility and EU Medical Device Regulation.
  • Notified Bodies and Competent Authorities.
  • Authorized Representatives: EU Declaration of Conformity and technical documentation for non-EU manufacturers.

Meet our Speakers



Affygility Solutions - Ardena - ARTeSYN Biosolutions - Bayer AG - Bayer Consumer Care AG - Biocon - Bristol Myers Squibb - Celgene - ChargePoint Technology Ltd - EVER Pharma Jena GmbH - Gedeon Richter - GlaxoSmithKline - Guido Maik Consulting - Hebeler Process Solution LLC - HPAPI Project Services Limited - ILC Dover - Ipsen - JLS International Germany - Krka, d.d., Novo mesto - Leeds Beckett University - Lonza - Lonza Pharma & Biotech - Lusochimica SpA - Merck Group - Minaken - Mitsui & Co. Italia S.P.A. - MSD - Novartis - Novasep - Oriento SA - Patheon, part of Thermo Fisher Scientific - Piramal Pharma Solutions - Pliva Croatia Ltd, TAPI Croatia - Praevena AG - Regeneron Pharmaceuticals, Inc - Skan AG - Takeda Ireland Limited - Umicore AG & Co KG - Others