Day One – 16 June 2025Monday, 16 June 2025

• Why do i need a QMS?
  • EU vs US
• How to build an efficient and sustainable QMS
• Best practices for keeping it lean

• After so many years of anticipation, has industry finally got the answers to their UK questions?

  • How will IVDs be regulated within the UK?

  • How does this compare to EU?

  • How can they streamline workload for both regions?

• Essential components of the technical file
• Best practices for documentation and evidence generation

• EU vs US
  • Identifying target markets and customer segments
  • Assessing market potential and competitive landscape
• How to curate a regulatory and clinical strategy from the ground up

• With EURLs now being designated, what can we expect for IVD approvals?

  • Which diagnostics are affected?

  • How does this change working processes for manufacturers, notified bodies and regulators?

• Working example: certifying IVDs with the involvement of EURLs

• Criteria for choosing a notified body, consultant, and Person Responsible for Regulatory Compliance (PRRC)
• The role of each supplier in the regulatory process

• What is the latest news on UK regulations for medical devices?

  • What do we know in terms of alignment with Europe, Switzerland and beyond?

  • Will manufacturers have transition times and what are the proposed dates?

  • What can manufacturers do now to prepare?

Please contact: Kristen Schott – kristen.schott@informa.com If you are interested in participating as a speaker, panelist, moderator or hosting a webinar

• Reflecting on the MDR journey so far, how efficient is the current process?

  • Which processes cause the most delays in product certification?

• Future reform: how can efficiency be improved?

  • Use of digital tools and AI

  • Multistakeholder collaboration

• Latest news on the regulatory pathway to Switzerland

• The role of the CH-REP

• Status of acceptance of FDA-products

• Status of the MRA EU-CH

• Priorities for 2025

• With Article 10a now having been in place for a few months, what initial learnings are there?

  • Is guidance clear on responsibilities?

  • Are there any common pain points arising from the process?

  • Are there any further plans to further reform the process for shortages?

• Since the Battery Regulation was released in July 2023, how have manufacturers been coping with adhering to the new regulation?

  • How does it tie in with the overall MDR?

  • How are notified bodies assessing batteries in devices?

  • What is the wider impact on public health?

• With IVDR having been in place for a few years, what are industry’s current experiences of managing portfolios?

  • How do they manage cyclical workload for all diagnostics?

  • What are their tips for optimising and streamlining workload?

• Risk and mitigation strategies for anticipating regulation changes

Please contact: Kristen Schott – kristen.schott@informa.com If you are interested in participating as a speaker, panelist, moderator or hosting a webinar

• Understanding the key elements of the metrological traceability concept described in ISO 17511

• Learning why global test standardization (first choice) or harmonization (second best) should be accomplished in laboratory medicine

• Learning about the rationale for global medical test (panel) standardization/harmonization and its strategic importance for the EHDS

• With the transition deadlines approaching fast for all diagnostic risk classes, how are we progressing in certifying IVDs under the IVDR?

  • Impact of 2024/1860

    • Has the new transition times alleviated capacity and transition concerns?

  • Which areas still remain a pain point and what steps are in place to aid this?

• Current regulatory status and Commission’s priorities for the next year

• What actually classifies as a structured dialogue under IVDR?

• Who can have one?

• What can be discussed during one?

• What do they aim to achieve?

• Current experiences with structured dialogues and lessons learned

• Best practices for getting the most out of them

The MedTech industry is facing an increasingly complex regulatory environment, with recent updates like the EU MDR, EU IVDR, and the FDA's shift toward ISO 13485 requiring rapid compliance adjustments. Traditional, siloed systems often impede efforts to keep up, as many manufacturers have historically focused on physical products rather than embracing digital innovation. With emerging priorities such as Software as a Medical Device (SaMD), cybersecurity, and sustainability, MedTech companies must adapt quickly or risk falling behind. As regulatory updates become more frequent, digital transformation and real-time traceability are no longer optional—they’re essential for staying competitive. This session will explore practical strategies for navigating these challenges, balancing compliance with innovation, and ensuring sustained success in MedTech. Attendees will gain actionable insights on rethinking strategy and embracing digital solutions to meet evolving regulatory demands, stay competitive, and go to market faster.

Attendees will learn actionable strategies for navigating the complex regulatory landscape and driving digital transformation, ensuring MedTech companies stay compliant, competitive, and innovative in a rapidly evolving market and ultimately go to market faster.

• Key changes and implications for SMEs
• Understanding the regulatory classification system

Please contact: Kristen Schott – kristen.schott@informa.com If you are interested in participating as a speaker, panelist, moderator or hosting a webinar

• Be a Success-Enabler
• Secure a Place at the Table as a Full Partner
• Better Processes Produce Better Products

• Funding
  • Overview of funding options (e.g., grants, loans, venture capital, private equity)
  • Creating a compelling investment pitch
• Pricing
  • Methods to evaluate and determine pricing
• Reimbursement
  • Understanding reimbursement pathways in different European countries

• With the first set of deadlines now only months away, how are all stakeholders coping?

  • Are notified bodies keeping up with submissions?

  • Are manufacturers submitting in time?

• Current European outlook

  • Does Europe look to be in a better shape, having extended the transition deadlines?

  • Which areas are still causing concern?

  • Proposals for ensuring European healthcare continues moving forward

• New regulatory frame in Europe - MDR challenges for all the stakeholders

• Compliance strategies to fulfil the requirements – ROBUST RECEPTION

• Lessons learned from our experience