Medical Device Regulations

Significant regulatory shift in UK that may impact 𝗖𝗔𝗥-𝗧 delivery: At-patient manufacturing!   With summer holidays and other industry happening, this news may have passed you by (it did me!): As of 23rd July 2025, the MHRA (the UK regulator) legally allows flexible, innovative manufacturing approaches such as Point-of-Care and decentralised/distributed modular manufacturing for ATMPs including CAR-Ts.   𝗪𝗵𝗮𝘁’𝘀 𝘁𝗵𝗲 𝗯𝗮𝗰𝗸𝗴𝗿𝗼𝘂𝗻𝗱 𝗳𝗼𝗿 𝘁𝗵𝗶𝘀: 🔹 MHRA innovation office has been receiving enquiries around this kind of manufacturing since 2014 – but no regulatory framework was in place to allow for PoC or modular manufacturing. 🔹 As technology advances – particularly ATMPs – new manufacturing modalities are required that can take place in hospitals, clinics and even the patients own home! 💭 𝗜𝗺𝗮𝗴𝗶𝗻𝗲 𝘁𝗵𝗮𝘁, 𝗵𝗮𝘃𝗶𝗻𝗴 𝗮𝗻 𝗮𝘂𝘁𝗼𝗹𝗼𝗴𝗼𝘂𝘀 𝗖𝗔𝗥-𝗧 𝗺𝗮𝗻𝘂𝗳𝗮𝗰𝘁𝘂𝗿𝗲𝗱 𝗮𝗻𝗱 𝗱𝗲𝗹𝗶𝘃𝗲𝗿𝗲𝗱 𝘄𝗶𝘁𝗵𝗶𝗻 𝘆𝗼𝘂𝗿 𝗼𝘄𝗻 𝗵𝗼𝗺𝗲. 𝗛𝗼𝘄 𝘄𝗶𝗹𝗹 𝗶𝘁 𝘄𝗼𝗿𝗸? 🔹  The technical solutions are still in development. Notably, Spain has made some great progress on establishing localised CAR-T production centres in Barcelona and Navarra. 🔹 A centralised “Hub” control site will be responsible for the decentralised “Spoke” sites; being responsible for documentation, quality, release and inspections. 🔹 A Decentralised Manufacturing Master File (DM MF) is required to be managed by the control site with annual reporting to MHRA 🔹 GMP and Pharmacovigilance requirements are maintained and must be have appropriate management plans prior to approval   𝗜𝗻 𝘀𝘂𝗺𝗺𝗮𝗿𝘆: This legislation marks a significant regulatory shift, accommodating disruptive innovation in medicine manufacture and delivery. MHRA has adopted a flexible, guidance-led approach supported by stakeholder feedback, with a strong emphasis on collaboration and quality assurance. Links to the MHRA webinar and the guidance document in the comments 👇 𝗧𝗵𝗶𝘀 𝗵𝗮𝘀 𝗯𝗲𝗲𝗻 𝗵𝗮𝗶𝗹𝗲𝗱 𝗮𝘀 𝗮 𝗳𝗶𝗿𝘀𝘁 𝗮𝗺𝗼𝗻𝗴 𝗿𝗲𝗴𝘂𝗹𝗮𝘁𝗼𝗿𝘀 – but do you think this puts the UK in a strong position for systems developers?  💬 As always, let me know your thoughts in the comments below.

🔍 𝐀 𝐂𝐥𝐢𝐧𝐢𝐜𝐢𝐚𝐧'𝐬 𝐆𝐮𝐢𝐝𝐞 𝐭𝐨 𝐄𝐯𝐚𝐥𝐮𝐚𝐭𝐢𝐧𝐠 𝐃𝐢𝐠𝐢𝐭𝐚𝐥 𝐇𝐞𝐚𝐥𝐭𝐡 𝐓𝐨𝐨𝐥𝐬 As a GP immersed in the digital health world, I'm often asked by fellow clinicians: "How do we know if a digital health tool is actually any good?" 📋 Here's your practical quality checklist on what to look out for, questions to ask and nuances that can make a big difference! 🔏 𝐑𝐞𝐠𝐮𝐥𝐚𝐭𝐨𝐫𝐲 𝐒𝐭𝐚𝐭𝐮𝐬 & 𝐂𝐞𝐫𝐭𝐢𝐟𝐢𝐜𝐚𝐭𝐢𝐨𝐧𝐬 ✅ Is it EU MDR, UKCA or FDA certified? (e.g. Ada Assess, our flagship product is MDR Class IIa certified) ✅ Know your classifications! (e.g. Class I medical devices in the EU have the lowest perceived risk. In many cases, the manufacturer can self-certify Class I devices without the involvement of a notified body. This risk class includes products like stethoscopes, bandages, or glasses!) ✅ ISO 13485 certification (shows commitment to quality management) ✅ Data security certifications - ISO 27001, HIPAA compliance, GDPR (show they take data privacy seriously) 🔗 See The Strategic Value of EU MDR & ISO 13485 in Digital Health: https://lnkd.in/eNit_dWa 🥼 𝐄𝐯𝐢𝐝𝐞𝐧𝐜𝐞 𝐁𝐚𝐬𝐞 ✅ Publicly available clinical studies (peer-reviewed is gold standard) ✅ Real-world evidence and performance data ✅ Transparent reporting of limitations and uncertainties ✅ Independent validation studies (not just internal testing) 🔗 See Ada Health's Clinical Studies: https://lnkd.in/ewswDfcV 🏥 𝐏𝐨𝐬𝐭-𝐌𝐚𝐫𝐤𝐞𝐭 𝐒𝐮𝐫𝐯𝐞𝐢𝐥𝐥𝐚𝐧𝐜𝐞 ✅ Active safety monitoring systems ✅ Regular performance updates and transparency reports ✅ Clear processes for handling adverse events ✅ Continuous performance monitoring, especially for AI-based tools 👔 𝐂𝐨𝐦𝐩𝐚𝐧𝐲 𝐀𝐜𝐜𝐞𝐬𝐬𝐢𝐛𝐢𝐥𝐢𝐭𝐲 & 𝐒𝐮𝐩𝐩𝐨𝐫𝐭 ✅ Dedicated medical safety team ✅ Clear channels for clinical feedback ✅ Responsive to safety concerns ✅ Regular updates and communication about changes 🔗 See Prioritising Patient Safety in Digital Health: https://lnkd.in/enUJCghz) 🤝 𝐈𝐦𝐩𝐥𝐞𝐦𝐞𝐧𝐭𝐚𝐭𝐢𝐨𝐧 𝐒𝐮𝐩𝐩𝐨𝐫𝐭 ✅ Were you involved in designing/evaluating the tool? ✅ Have you been provided with clinical workflow integration guidance? ✅ Training materials and support? ✅ Clear documentation of intended use (and when not to use the product!) 🎯 𝐏𝐫𝐨 𝐓𝐢𝐩: Engage with the company's medical team. A quality digital health partner should welcome clinical dialogue and demonstrate a genuine commitment to patient safety and co-designing products. 𝐑𝐞𝐦𝐞𝐦𝐛𝐞𝐫: The best digital health tools aren't just technically sound - they're built on a foundation of clinical understanding and regulatory rigour. They should enhance, not complicate, your clinical practice. 🤔 What quality aspects do you look for when evaluating digital health tools? Share your experiences below!

🤩 A milestone for #MedTech: Digital technical documentation will enter EU legislation This week, the European Commission published a proposal to simplify the european laws MDR and IVDR for #medicalDevices and in vitro diagnostic devices. 🌟 For the first time ever, the draft includes explicit provisions on the digitalisation of technical documentation and conformity assessment (new MDR Article 52b / IVDR Article 48b). 👉 This is a true novum for the medical device industry and a strong signal that that the #digitalisation of regulatory processes and related #technicalDocumentation plays an important role for the industry. --- 😁 Personally, this proposal makes me genuinely happy: I have been working on solutions for these topics for many years now. Seeing these concepts reflected in a concrete legislative proposal is highly motivating and reinforces my belief that this work truly matters. Not only am I proud of my work at the avasis solutions GmbH (avasis Group), but above all I am proud of our collaborative work in the non-profit Medical Device Knowledge Units (MDKU) e.V. association: More than five years ago, we began to put into practice the idea of a unified data model for technical documentation of medical devices. We will soon publish DIN SPEC 91509 with a first release. Our goal has always been to enable structured, interoperable and reusable technical documentation - digital by design, not a collection of static PDFs. Because that is "real digitalisation" and the foundation for a useful application of AI. ❇️ From documents to data! ❇️ --- Seeing this principle now reflected in a legislative proposal confirms that the direction was right - and that collaborative, pre-competitive work can help prepare the ground for future regulation 🥳 I am more motivated than ever to continue contributing to this transformation and to help ensure that these new legal provisions can be translated into practical, scalable and industry-ready solutions. --- 👉 How do you see the future of digital technical documentation under MDR & IVDR? I’d love to hear perspectives from manufacturers, notified bodies and regulators!

MDR/IVDR Are Just the Tip of Your Regulatory Iceberg—Look Beyond Them A cornerstone of successful medical device development is identifying all regulatory requirements. The MDR (Regulation (EU) 2017/745) and IVDR (Regulation (EU) 2017/746) provide a vast catalog of device requirements and company procedures. Standards then offer additional details for compliance. However, many see this as the entire iceberg and assume it’s enough for full compliance. The reality is different. Medical devices and manufacturers often need to comply with multiple regulations. It’s crucial to identify all applicable regulations beyond the obvious ones. Here are 7 regulations and directives many miss but are often essential: EU AI Act (Proposal COM/2021/206) → Crucial for any medical device incorporating AI. → Adds a certification framework beyond MDR/IVDR. → Overlapping requirements mean a thorough gap analysis is essential. European Health Data Space Regulation (Proposal COM/2022/197) → Central to unlocking cross-border health data sharing in the EU. → A framework for primary and secondary use of electronic health data. → Compliance requires alignment with GDPR and national health laws. Radio Equipment Directive (2014/53/EU) → Applies to devices with wireless communication (e.g., Bluetooth). → EMC testing under MDR isn’t enough for compliance. → Requires additional IFU content, such as wireless frequency specifications. General Data Protection Regulation (Regulation (EU) 2016/679) → Applies to all devices interacting with personal data. → Covers even non-sensitive data, beyond health-related information. → Expected since its enforcement began in 2018. Battery Regulation (Proposal COM/2020/798) → Relevant for devices with rechargeable or disposable batteries. → Mandates user access to batteries for removal or replacement. → Requires compliance with labeling and recycling standards. RoHS (Directive 2011/65/EU) and REACH (Regulation (EC) No 1907/2006) → Limit hazardous substances in device materials. → Biocompatibility doesn’t guarantee compliance with these regulations. → Crucial during material selection for physical devices. WEEE (Directive 2012/19/EU) → Governs proper decommissioning and disposal of electrical devices. → Includes exemptions for implantable and potentially infectious devices. → Often Requires agreements with waste management organizations. By identifying them early, the iceberg may remain large, but at least you’ll have transparency and control. P.S. What other regulations or directives would you add to this list? ⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡ MedTech regulatory challenges can be complex, but smart strategies, cutting-edge tools, and expert insights can make all the difference. I’m Tibor, passionate about leveraging AI to transform how regulatory processes are automated and managed. Let’s connect and collaborate to streamline regulatory work for everyone! #automation #regulatoryaffairs #medicaldevices

In 2023, the FDA issued draft guidance on "predetermined change control plans for AI medical devices". This new update will allow for modifications to be made without changing the efficacy or safety of the medical device, provided these changes align with the predetermined plan. This is a crucial step in dealing with the fast-paced evolution we see with continuously learning algorithms. We talked to 𝐖𝐞𝐫𝐨𝐧𝐢𝐤𝐚 𝐌𝐢𝐜𝐡𝐚𝐥𝐮𝐤, 𝐒𝐚𝐌𝐃 𝐋𝐞𝐚𝐝 at HTD Health to better understand the challenges in regulating AI algorithms in healthcare. "𝐖𝐡𝐚𝐭 𝐬𝐭𝐞𝐩𝐬 𝐜𝐨𝐮𝐥𝐝 𝐰𝐞 𝐞𝐱𝐩𝐞𝐜𝐭 𝐟𝐫𝐨𝐦 𝐭𝐡𝐞 𝐅𝐃𝐀 𝐢𝐧 𝟐𝟎𝟐𝟒 𝐢𝐧 𝐫𝐞𝐠𝐮𝐥𝐚𝐭𝐢𝐧𝐠 𝐀𝐈? In 2024, the FDA appears to be steering a proactive course to address the complexities of regulating AI in healthcare. A key initiative is the ambitious plan to draft 18 new documents, which signals a robust effort to provide clearer guidelines and standards for stakeholders navigating the realms of AI, cybersecurity, and other digital health technologies. This move reflects the FDA's recognition of the rapidly evolving landscape of digital health and its commitment to fostering a well-regulated environment that both upholds patient safety and encourages innovation. In parallel, the FDA's IT Modernization Plan for 2024 to 2027 is set to enhance the agency's technological framework, aiming to better support clinical trials and sponsors. On the regulatory front, the FDA's intention to categorize more AI tools as devices showcases a move towards a tighter regulatory framework. This initiative aims at ensuring the safety and efficacy of these tools, reflecting the FDA's cautious approach to manage the potential risks associated with rapidly evolving AI technologies in healthcare. Meanwhile, the continuous approval of AI-enabled devices, especially in radiology, highlights the FDA's recognition of AI's potential to enhance diagnostic accuracy and efficiency. By continuing to approve these devices, the FDA is facilitating the integration of AI in healthcare, which is likely to lead to improved patient outcomes and streamlined workflow for healthcare providers." https://lnkd.in/eDK5auu2

Big AI news for the MedTech sector! The European Commission released its new health package yesterday, which includes a significant amendment to how the AI Act would apply to medical technologies. Notably, the proposal would shift the Medical Devices Regulation (MDR) and the In Vitro Diagnostic Regulation (IVDR) from Annex I, Section A to Section B. While this may look like a technical adjustment, the implications could be substantial. Industry stakeholders have long highlighted friction between the AI Act and existing MedTech regulatory frameworks, and this change could reshape how those tensions are managed. Under Section A, products must meet the AI Act’s high-risk obligations immediately in parallel with MDR/IVDR requirements. By contrast, placing these rules under Section B means compliance would be channelled primarily through the sector-specific regime, with the AI Act applying as clarified through secondary legislation.

Risk Management in Medical Devices: More Than a Checklist In medical devices, risk management is not a one-time activity—it’s a continuous process that directly impacts patient safety and product reliability. Under ISO 14971 and aligned with ISO 13485, risk management is integrated into every stage of the product lifecycle—from design to post-market use. At its core, risk management is about answering three simple but critical questions: What can go wrong? How likely is it? And what is the impact? The process typically begins with hazard identification. This involves identifying all possible sources of harm—electrical, mechanical, biological, usability-related, or even software failures. In daily work, this often happens during design discussions, failure analysis, or even while reviewing customer complaints. Once hazards are identified, the next step is risk analysis and evaluation. Here, risks are assessed based on severity and probability. Not all risks can be eliminated, but they must be reduced to an acceptable level. This is where teams often make a mistake—accepting risks without proper justification or documentation. The most critical step is risk control. Controls can include design changes, protective measures (like alarms or insulation), or clear instructions in labeling. The priority should always be to eliminate risk through design rather than relying only on warnings or user instructions. An important but often overlooked aspect is residual risk evaluation. Even after controls are applied, some level of risk remains. This must be evaluated to ensure it is acceptable when weighed against the device’s benefits. Risk management does not stop after product release. Through post-market surveillance, real-world data such as complaints, adverse events, and user feedback must be continuously reviewed. If new risks are identified, they should feed back into the risk management file and trigger updates. In practice, risk management is closely linked with CAPA, design changes, and regulatory compliance. A poorly maintained risk file is one of the most common findings during audits. A mature organization treats risk management not as documentation, but as a decision-making tool. It guides design choices, improves product safety, and builds confidence with regulators and users. Ultimately, effective risk management ensures that innovation does not come at the cost of safety—and that every device delivered performs reliably in real-world conditions.

𝗛𝗲𝗿𝗲'𝘀 𝗺𝘆 𝟳-𝘀𝘁𝗲𝗽 𝗽𝗹𝗮𝘆𝗯𝗼𝗼𝗸 𝗳𝗼𝗿 𝗲𝗻𝘀𝘂𝗿𝗶𝗻𝗴 𝘀𝗺𝗼𝗼𝘁𝗵 𝗿𝗲𝗴𝘂𝗹𝗮𝘁𝗼𝗿𝘆 𝘀𝘂𝗯𝗺𝗶𝘀𝘀𝗶𝗼𝗻𝘀 𝘁𝗵𝗮𝘁 𝗜'𝘃𝗲 𝗿𝗲𝗳𝗶𝗻𝗲𝗱 𝗼𝘃𝗲𝗿 𝘆𝗲𝗮𝗿𝘀 𝗶𝗻 𝘁𝗵𝗲 𝗠𝗲𝗱𝗧𝗲𝗰𝗵 𝗾𝘂𝗮𝗹𝗶𝘁𝘆 𝗮𝗻𝗱 𝗿𝗲𝗴𝘂𝗹𝗮𝘁𝗼𝗿𝘆 𝘀𝗽𝗮𝗰𝗲: 𝟭. 𝗦𝘁𝗮𝗿𝘁 𝘄𝗶𝘁𝗵 𝘁𝗵𝗲 𝗲𝗻𝗱 𝗶𝗻 𝗺𝗶𝗻𝗱 - 𝟭𝟴-𝟮𝟰 𝗺𝗼𝗻𝘁𝗵𝘀 𝗯𝗲𝗳𝗼𝗿𝗲 𝘀𝘂𝗯𝗺𝗶𝘀𝘀𝗶𝗼𝗻 • Map your regulatory strategy to your commercial goals • Identify your regulatory pathway early (510(k), De Novo, PMA) • Build testing protocols based on predicate devices when applicable 𝟮. 𝗗𝗲𝘀𝗶𝗴𝗻 𝘆𝗼𝘂𝗿 𝗤𝘂𝗮𝗹𝗶𝘁𝘆 𝗠𝗮𝗻𝗮𝗴𝗲𝗺𝗲𝗻𝘁 𝗦𝘆𝘀𝘁𝗲𝗺 𝗳𝗼𝗿 𝗲𝗳𝗳𝗶𝗰𝗶𝗲𝗻𝗰𝘆 • Implement ISO 13485 principles from day one • Focus on the 7 critical SOPs that impact submissions most • Avoid the common trap of documentation overload (I've seen startups with 200+ SOPs when 35-40 would suffice) 𝟯. 𝗩𝗮𝗹𝗶𝗱𝗮𝘁𝗲 𝘆𝗼𝘂𝗿 𝘁𝗲𝘀𝘁𝗶𝗻𝗴 𝗺𝗲𝘁𝗵𝗼𝗱𝗼𝗹𝗼𝗴𝘆 𝗯𝗲𝗳𝗼𝗿𝗲 𝗲𝘅𝗲𝗰𝘂𝘁𝗶𝗻𝗴 • Pre-validate test methods with 3-5 pilot runs • Engage with testing labs that have FDA submission experience • Document protocol deviations properly (we found 63% of submissions get delayed due to inadequate deviation management) 𝟰. 𝗟𝗲𝘃𝗲𝗿𝗮𝗴𝗲 𝗽𝗿𝗲-𝘀𝘂𝗯𝗺𝗶𝘀𝘀𝗶𝗼𝗻 𝗺𝗲𝗲𝘁𝗶𝗻𝗴𝘀 𝘀𝘁𝗿𝗮𝘁𝗲𝗴𝗶𝗰𝗮𝗹𝗹𝘆 • Schedule Q-Sub meetings 9-12 months before planned submission • Prepare focused questions (limit to a few critical issues) • Follow up with written summaries within the allocated time 𝟱. 𝗕𝘂𝗶𝗹𝗱 𝗮 𝘀𝘂𝗯𝗺𝗶𝘀𝘀𝗶𝗼𝗻 "𝘄𝗮𝗿 𝗿𝗼𝗼𝗺" • Assemble cross-functional team (R&D, Clinical, Quality, Regulatory) • Create submission trackers with accountability metrics • Hold twice-weekly stand-ups in the 90 days before submission 𝟲. 𝗖𝗼𝗻𝗱𝘂𝗰𝘁 𝘁𝗵𝗶𝗿𝗱-𝗽𝗮𝗿𝘁𝘆 𝘀𝘂𝗯𝗺𝗶𝘀𝘀𝗶𝗼𝗻 𝗿𝗲𝘃𝗶𝗲𝘄 • Have external experts review 100% of your technical documentation • Use submission management platforms like RADAR or MasterControl • Schedule review 45-60 days before planned submission date 𝟳. 𝗣𝗿𝗲𝗽𝗮𝗿𝗲 𝗳𝗼𝗿 𝗶𝗻𝘁𝗲𝗿𝗮𝗰𝘁𝗶𝘃𝗲 𝗿𝗲𝘃𝗶𝗲𝘄 • Anticipate FDA questions with "pre-mortem" analysis • Have subject matter experts on standby during review period • Create response templates for common deficiency categories I learned these lessons the hard way. Early in my career I worked at a company where we had three submissions rejected due to inconsistent test data formatting. Now we use standardized data presentation templates that have cut our Additional Information requests by 72%. 𝗧𝗔𝗞𝗘𝗔𝗪𝗔𝗬: Regulatory success is about methodical preparation and strategic execution. The companies that view regulatory as a strategic function rather than a compliance burden consistently outperform their peers in time-to-market by an average of 7 months If you're preparing for an FDA submission in the next 12-18 months, I'd be happy to share our pre-submission checklist. Just message me directly

The FDA and Centers for Medicare & Medicaid Services just addressed one of the biggest bottlenecks in healthcare innovation. For years, approval was only half the story. The real delay came after, waiting for reimbursement. Now, that gap is starting to close. Introducing a new pathway: RAPID (Regulatory Alignment for Predictable and Immediate Device). Key updates: 1. Earlier alignment on evidence: CMS engages earlier in the process, helping define what’s needed for both approval and coverage. 2. Synchronized decision timing: Once a device is authorized, CMS will issue a proposed coverage decision the same day. 3. Compressed timeline to coverage: A structured 30-day public comment period follows, with potential coverage decisions in ~60–90 days, not years. 4. Focus on breakthrough devices: Applies to FDA-designated breakthrough devices (Class II & III), where speed matters most. This is a structural shift. Not just faster approval, but a clearer, more predictable path to reimbursement. Because in healthcare, innovation doesn’t matter if it doesn’t reach patients. For founders, this changes how you think about: clinical strategy, evidence generation, and go-to-market from day one. At Serendipity Impact VC, we focus on this exact gap, between what works in science, and what actually gets used in the real world. Full announcement in the comments.