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EU MDR: Implementation Insights And Expert Guidance To Help You Achieve Compliance

Navigating Medical Device Regulatory Affairs, Clinical Considerations, Post Market Surveillance & Vigilance, Legal Challenges And More...

With Direct Competent Authority, Notified Body And Industry Guidance

Implement The EU MDR With Confidence: Learn From The Experts


EU Medical Device Regulation
EU Medical Device Regulation
  • Gain direct Competent Authority and Notified Body feedback from MHRA (Invited), DKMA, BMG (Federal Ministry of Health – Germany), TÜV SÜD Product Service, BSI and SGS
  • Delve into Notified Body designation: Timelines, scope and resource
  • Get to grips with the role of Economic Operators
  • Brexit and the EU MDR: What will the impact be for industry?
See The Full EU MDR Agenda
Clinical Evaluations & Investigations For Medical Devices
Clinical Evaluations & Investigations For Medical Devices
  • Hear FAMHP and TÜV SÜD Product Service delve into regulatory expectations for clinical evaluations and investigations
  • What does the term “sufficient” clinical data actually mean? Join the discussion...
  • Explore how the new regulations impact data management
  • Examine the new requirements for Clinical Evaluation Reports under the EU MDR
See The Full Clinical Evaluations & Investigations For Medical Devices Agenda
Medical Device Post Market Surveillance & Vigilance
Medical Device Post Market Surveillance & Vigilance
  • Get the latest post market implementation insights from the likes of Edwards Lifesciences, Berlin Heart GmbH, BioMerieux, Ortho Clinical Diagnostics, Straub Medical and more...
  • What are the new requirements for Post Market Clinical Follow-up (PMCF)? Gain clarification...
  • How have companies managed the additional workload? Join the discussion.
  • Explore how to successfully bring together Risk Management, Clinical Evaluation and Post Market Surveillance Plans
See The Full Medical Device Post Market Surveillance & Vigilance Agenda

Clinical Outsourcing For Medical Devices
Clinical Outsourcing For Medical Devices
  • Hear leading industry perspectives from Histogenics, JnJ Medical, Philips, Cochlear AG, Medtronic
  • Explore strategies for successfully selecting vendors with the most relevant experience for your medical devices
  • Gain top tips for ensuring effective sponsor/vendor relationship management
  • Learn how to assess the benefits of outsourcing versus in-house
See The Full Clinical Outsourcing For Medical Devices Agenda
EU Medical Device Law
EU Medical Device Law
  • Benefit from in-house counsel perspectives including Boston Scientific, Abbott Laboratories UK Ltd, Zimmer Biomet, Stryker GmbH & Co.KG and more...
  • Get to grips with the legal preparations being made in the transition to the EU MDR
  • Explore practical legal solutions for IP, clinical investigation, reimbursement and GDPR challenges
  • Gain strategic legal advice on new market developments and risk management strategies
See The Full EU Medical Device Law Agenda
Drug Device Combination Products
Drug Device Combination Products
  • Navigate the latest regulatory requirements for Drug Device Combination Products with feedback from FAHMP, The FDA and TÜV SÜD
  • Gain clarification on how Notified Bodies are interpreting Article 117 and how to prepare
  • Explore the EU MDR in relation to borderline products and get to grips with the new industry requirements
  • Tackle combination product classifications and regulations in global markets

See The Full Drug Device Combination Products Agenda

Sterilisation & Reprocessing of Medical Devices
Sterilisation & Reprocessing of Medical Devices
  • Get Competent Authority and Notified Body perspectives from RIVM and TÜV SÜD Product Service GmbH
  • Examine the impact of the EU MDR & new ISO standards on sterilisation and reprocessing of medical devices
  • Hear the latest on new EU legislation planned for reprocessing single use devices (SUDs)
  • Share industry case studies on EO & gamma validation, and reducing EO residue levels
See The Full Sterilisation & Reprocessing of Medical Devices Agenda
MDTI TRAINING COURSE: Medical Device Regulatory Project Management
MDTI TRAINING COURSE: Medical Device Regulatory Project Management
  • Get a detailed introduction to project management processes and techniques
  • Gain an understanding of how to apply regulatory requirements to a project management methodology
  • Learn how to effectively manage medical device project cycles
  • Develop your knowledge of project management techniques through additional considerations

See The Full Medical Device Regulatory Project Management Training Course Agenda

Meet The EU MDR Speakers