Medical Devices Newsletter

May 2026

Welcome to the May edition of our Medical Devices Newsletter. This month, we bring you the latest updates, insights, and developments in the medical devices industry and regulatory updates. Dive in to stay informed and ahead in this ever-evolving field.

BSI remains committed to offering manufacturers efficient pathways for placing medical devices on the market. We continue to accept MDR, IVDR, and UKCA applications without restrictions, across all device types.

Find out more by visiting our dedicated webpage.

We are thrilled to launch BSI Medical Devices Toolkits.

These resources bring together key guidance covering regulatory schemes, quality management systems, specific technologies and our medical devices regulatory services portfolio - all in one place.

Whether you’re an established manufacturer, a startup or an SME, our toolkits help you quickly locate the guidance you need to keep your device safe and compliant.

On 5 May 2026 Regulation (EU) 2026/977 regarding Annex VII revision has been published on the OJEU.

At BSI, we are already actively progressing our implementation plans and aligning our processes to meet the new requirements as outlined in Annex VII. Our focus remains maintaining the highest standards of quality, rigor, and regulatory compliance.

We look forward continuing to support manufacturers in navigating these changes, bringing safe, effective medical devices to market.

Eligible devices enrolled in the BSI BtX Pathway will be prioritized during planning and resource allocation, in view of their potential to address unmet medical needs or offer clinically meaningful advantages over existing solutions. The devices will also benefit from the BSI Dedicated Interactive Review Service which will be offered at standard pricing. The BSI BtX Pathway enables more predictable and efficient progression through the required conformity assessments.

Combine the BtX Pathway with BSI Structured Dialogue and benefit from consistent, expert discussions from the earliest stages and throughout the certification process.

To find out more visit our dedicated webpage.

The clock is ticking: your IVDR application must be lodged with a Notified Body by 26 May 2026. Define your conformity assessment journey, understand timelines and ensure your legacy device remains compliant.

Then efficient onboarding, assessment capacity and expertise matter more than ever when selecting your Notified Body.

Secure your CDx transition with proven experts.

With MDSAP you can simplify compliance and achieve global expansion. With our expert auditors and global perspective, you gain:

• Confidence in your quality management system
• Recognition from regulatory authorities
• Access to international markets

Keeping pace with global regulation is becoming increasingly complex. With differing timelines across the EU, US, and Asia-Pacific regions, organizations are navigating a fragmented and fast-evolving regulatory landscape. This makes consistent global compliance a significant challenge. In this short clip, our President of Regulatory Services, Manuela Gazzard, highlights one of the key pressures facing industry today.

Watch the full interview to explore how organizations can respond to these challenges and build more resilient, future-ready compliance strategies.

Compliance Navigator is BSI’s regulatory document management tool designed by industry experts to help medical device and IVD manufacturers navigate complex compliance requirements with confidence. With access to thousands of curated standards, regulations, and guidance documents including BSI, ISO, IEC, ASTM, AAMI, and CLSI content - the platform enables teams to monitor changes, interpret requirements, and stay aligned with UK, EU, and MDSAP market expectations. Click the link below to watch how each Compliance Navigator feature helps your business save time managing compliance documentation.

Webinar | 20 May 2026 | 09:00 and 16:00 BST

Join this webinar to understand the upcoming mandatory use of EUDAMED (European Database on Medical Devices) from 28 May 2026.
We will cover key timelines, the first four mandatory modules, updates to BSI processes, and what manufacturers, importers, EU Authorized Representatives, and Notified Bodies need to do to prepare.

Webinar Series | 9, 16 & 23 June 2026

Join us for this easy to follow three part webinar series designed to help medical device manufacturers navigate EU MDR & IVDR with confidence and predictability. Across the series, our experts unpack how clearer alignment and early collaboration with BSI support the Breakthrough Device (BtX) pathway, effective use of Structured Dialogue, and fast track, interactive review models that reduce rework and protect timelines.

3-4 June 2026 | NEC, Birmingham

Come and meet BSI at Med-Tech Expo in Birmingham on 3-4 June. We’ll be in Hall 7, Stand LL53 and would love to connect.

Join us for our session, Get Ready for Market: A Startup’s Guide to ISO 13485 Compliance, on the Med-Tech Insights Stage. Hear from Ajith John and Michelle Rae, as they share insights for startups and growing manufacturers. The session will explore how to navigate ISO 13485 and build a quality management system that support your route to market.

Navigating MedTech compliance, understanding the MDR landscape, and getting guidance on the regulatory journey is critical when bringing medical devices to market. 

If you want to gain insights into these topics, join us at our Meet the Experts event in Paris on 30 June 2026 to hear from our experts and connect with your peers across the MedTech community:

Hear from BSI’s industry leaders and regulatory experts on navigating MedTech compliance. Gain a clear understanding of the MDR and IVDR landscape, including current timelines, updates, and regulatory requirements. Get guidance on the regulatory journey, from initial application through to conformity assessment and post certification.

Last week, our team had an amazing time attending the RAPS Euro Convergence 2026 event - one of the key gatherings for the medical device and regulatory industry. It was a great opportunity for us to really showcase our expertise and thought leadership across the MedTech space. Stay tune and join us at the next edition in Dublin!

MDR Clinical Requirements on spinal implants

Catch up on all webinars from our BSI Insight Series: Startup Edition in one place!