Date: 22 September 2021
Duration: 2 days
Location: Novotel Praha Wenceslas Square Hotel, Prague, Czech Republic
Cost: Please visit the website for more details.
Medical Device Regulations Summit 2021 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.