Author profile
Diana Hohage
Principal Consultant
Advises medical device and IVD manufacturers on regulatory strategy, technical documentation and risk management under MDR, IVDR and ISO 13485. 30 years in life sciences, including more than 15 in medical technology and over 8 in consulting; Lead Auditor for ISO 13485 and MDSAP.
Credentials: Lead Auditor ISO 13485, Lead Auditor MDSAP
LinkedInArticles by Diana Hohage
14 articles
FDA finalizes new 510(k) guidance for dental composite resins and dental curing lights
On 2 September 2026 the FDA issued two final Level 1 guidances for dental composite resins and dental curing lights. They replace the 2005 and 2006 documents and reset what a 510(k) submission is expected to show.
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Japan's 2026 pharmacy exemption for a specified high-control medical device
An MHLW notice adds starch-derived absorbable topical hemostatic material to the list of specified insured materials that a pharmacy may supply without a separate license to sell highly controlled medical devices. The route is conditional, and it changes neither approval nor reimbursement.
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MHRA and Manchester NHS launch a health innovation sandbox: an early signal for AI-enabled devices
The Manchester Sandbox moves the evidence conversation for AI-enabled medical devices into real NHS settings. It is a regulator-enabled evidence environment, not a new authorization pathway, and key operational details have not been published.
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PFAS fluoropolymers in medical devices: what the FDA's 2026 position means for manufacturers
The FDA sees no reason to restrict the continued use of fluoropolymers in medical devices. That statement is narrower than a general declaration that PFAS are safe, and it does not replace device-specific material characterization, biological evaluation or change control.
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The UK Health Bill and a potential Great Britain medical-device licensing regime
Government New Clause 94 would let the Secretary of State create product and personal licenses for defined medical-device activities in Great Britain. It is an enabling power, not an operating regime: nothing in it changes current obligations.
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MDR/IVDR under reconstruction: how Europe is recalibrating its medical device framework
From the accelerated evaluation and COM(2025) 1023 to market feedback, parliamentary work and Council negotiations: how the MDR/IVDR revision is really unfolding, and what it means for ongoing projects.
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From Digital Measurement to Regulatory Evidence
FDA's cross-center paper, published on 20 August 2026, provides a coherent framework for linking digital measurement technologies to regulatory-grade clinical evidence. A virtual public workshop on 27 August will examine the associated statistical and methodological considerations for digitally derived endpoints in clinical trials of drugs and biological products.
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FDA and generative AI: no new policy, but a regulatory framework is taking shape
On 18 August 2026 the FDA published its discussion paper on the regulation of generative AI-enabled medical devices. It is not draft guidance, not final guidance and not a new policy statement. It should not, however, be dismissed as merely exploratory.
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FDA Recognition List 066: managing evidence boundaries, not just updating a standards register
What medical-device manufacturers should do now for biological evaluation, labeling, cybersecurity, and digital health data. Recognition List 066 is easy to misread as routine standards maintenance. It affects the evidentiary architecture behind US premarket submissions.
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UK MedTech: MHRA proposes material changes to medical-device fees from April 2027
The proposed annual post-market surveillance registration fee would rise from £300 to £511, an increase of around 70 per cent. The practical impact depends less on the headline amount than on how an organization's registered portfolio maps across chargeable GMDN categories.
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AI Act: what applies on 2 August 2026, and what does not
On 2 August 2026 the AI Act becomes broadly applicable. The specific obligations for high-risk AI systems are not part of that: they arrive later, and for AI-based medical devices one further condition applies. Which date counts for which system, in one overview.
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Quality Agreements With Critical Suppliers
A quality agreement is not an extended purchase order. It is the operating interface between two quality management systems. Which audit, change and cost rules it has to carry so that it gives a clear answer when it matters.
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MDR Meets the EU AI Act: The Trilemma for AI Software
AI software that qualifies as a medical device must satisfy the MDR and the EU AI Act at the same time. The costly mistake is not the second regulation, but running two separate worlds of documentation. Where MDR classification and AI Act high-risk status interlock.
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AI in Medical Technology: The Interplay of AI Act, MDR and IVDR
When does AI software qualify as a medical device? What requirements does the AI Act place on high-risk systems? And what do the current deadlines mean concretely for manufacturers? This whitepaper structures the regulatory complexity and translates it into options for action.
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Image notice: The illustrative and header images were generated using AI and do not depict real people, places, or events. The portrait photographs show real people.