This site is part of the Informa Connect Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC's registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 3099067.

MedTech Summit
Hybrid Event, 20 - 24 June 2022
In-Person: Clayton Hotel Burlington Road, Dublin, IrelandDigital Experience: One track will be live-streamed each day in BST time zone, with on-demand recording access for all other tracks made available from the afternoon of the following day. Learn more on the Digital Experience page.

Hybrid Event, 20 - 24 June 2022
In-Person: Clayton Hotel Burlington Road, Dublin, Ireland,
Digital Experience: One track will be live-streamed each day in BST time zone, with on-demand recording access for all other tracks made available from the afternoon of the following day. Learn more on the Digital Experience page.

EU MDR & UKCA: Take Control Of Your Regulatory Success

Navigate the regulatory landscape with case study insights from medical device manufacturers and Notified Body feedback

UDI. EUDAMED. MDR Audits. Economic Operators. Borderline Products.

Overcome The Challenges Of Implementing EU MDR and MDCG Guidance

Dive Into The Latest Regulatory Requirements With Expert Guidance

  • Notified Body feedback on first experiences with substance-based medical devices and how to interpret the EU MDR requirements including classification and application of Rule 21
  • Prepare your MDR technical documentation submissions for technical expert review with feedback from BSI
  • Explore MedTech’s lessons learnt one year on from EU MDR Implementation with Notified Body and industry experts with IMQ, Bayer & Implantica

Implementing The EU Medical Device Regulations

  • Explore the current status of EUDAMED, challenges and how to overcome them
  • Preparing for EU MDR audits and virtual audits: Experiences and lessons learnt
  • Get to grips with the responsibilities of Economic Partners: Manufacturer interpretations and implementation feedback

Regulatory Change Across Europe & Beyond

  • UKCA Mark: Where are we now? Comparisons with the EU MDR and how you can prepare for compliance
  • Understand how the EU MDR and IVDR are impacting European market access decisions with a big picture panel including industry and legal perspectives
  • Practical advice for global implementation of UDI and labelling requirements for medical devices