MedDev Day - Programme

Session moderated by
Bassil Akra, Chief Executive Officer at AKRA TEAM
Arkan Zwick, Corporate Director Regulatory Affairs at CROMA Pharma

Interactive session involving working in groups: an opportunity to foster collaborative discussions, encourage diverse perspectives and facilitate the exchange of ideas.

The presentation will cover the following topics:

• Being an early adopter and adapting to evolving requirements and expectations
• Experience with multiple NBs across a large portfolio
• Managing WW registration impact
• Moving from implementation to sustaining life-cycle

In the past, the CE mark served as a passport for medical devices to access markets across the European Union (EU), United Kingdom (UK), and Switzerland. However, recent changes—Brexit in 2020 and the lack of an updated Mutual Recognition Agreement between the EU and Switzerland in 2021—have altered this landscape. Having the CE mark alone is no longer sufficient for the UK and Swiss markets. Manufacturers must now navigate additional requirements specific to each country/region.

In this session we will explore the current medical device requirements for the UK and Swiss markets, examining the challenges faced from both the manufacturer and authorised representative’s perspective.

Software medical devices present increasing challenges to regulatory professionals in determining a straightforward regulatory path to market.

Between challenges of cybersecurity, AI considerations, pre and post market clinical data requirements, how to handle service releases and changes post approval, vigilance expectations of authorities etc. no market approval and maintaining that approval is easy.

This session provides some tips on how to best determine and prepare the right regulatory strategy and how to navigate high risk software to approval in the EU and US context?

The presentation will cover the following topics:

• Decoding MDR post-market surveillance requirements
• Essential steps to ensure compliance and meet new regulatory demands without overburdening resources
• Challenges and considerations for PMS practices for legacy devices

The EU keeps tweaking the MDR and the IVDR to fix transitional issues. But the Commission has announced that a targeted review is in the works. And there may be more underway!

This session will cover all new requirements (the January 2024 proposal), the newer requirements (what could the Commission want in a targeted review?) and the newest requirements (what else may be in the pipeline that is not so visibile yet?).

Exploring the characteristics and key differences between both regulatory pathways to help selecting strategies and optimize product approval.

Since the MDR fundamentally revised the European system for medical devices it aimed to establish a transparent and predictable system for devices while supporting innovation, smooth functioning of the internal market and promote global convergence and trade.

Three years after its date of application industry has gained experience in working within the revised environment and achieving MDR conformity assessments and quality management system compliance.

These efforts required significant industry investments and are done in difficult macroeconomic trends of high inflation, constrained capital markets, uncertain supply and rising geopolitical tensions.

In this environment and seven years after MDR publication industry questions whether the MDR has improved the regulatory system and whether the regulation delivers on its objectives.

The presentation will critically assess the progress made towards transparency, predictability, innovation, internal market and global trade from a legal and systems perspective by comparing MDR requirements to good practices from other regulations such as medicinal products or global regulatory processes such as PMA to assess whether the European system has improved.

The presentation will also illustrate needed enhancements from an industry perspective to potentially be included in next revisions of the regulatory system.