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NewsAug 4, 2026

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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Hazard and Risk Analysis: Which Method Answers Which Question

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RAPS AI in Regulatory Conference 2026: Entourage Is in Barcelona

On 5 and 6 November 2026, RAPS brings regulatory professionals to Barcelona to look at what artificial intelligence is doing to regulatory work. Entourage is there as a Bronze sponsor, with a table across both days.

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DCAT Week 2027 in New York: Entourage Will Be on Site
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DCAT Week 2027 in New York: Entourage Will Be on Site

From 15 to 18 March 2027, the international pharma supply chain meets in New York for DCAT Week. Entourage will be on site with Andreas Weirich and Moritz Haucke.

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Three cyber deadlines hit the same teams, and the first one has already passed
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Three cyber deadlines hit the same teams, and the first one has already passed

11 and 12 September 2026 are one day apart. The first starts the reporting obligations under the Cyber Resilience Act, the second brings the Data Act design obligation to bear on newly placed connected products. The third deadline is not a coming one: the German NIS-2 implementing act has applied since December 2025.

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Articles & Whitepapers

MDR/IVDR under reconstruction: how Europe is recalibrating its medical device framework
Article

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
Article

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
Article

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
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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
Article

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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Hazard and Risk Analysis: Which Method Answers Which Question
Article

Hazard and Risk Analysis: Which Method Answers Which Question

PHA, FTA, ETA, FMEA, HAZOP and HACCP each answer a different question, and none of them produces a finished risk analysis on its own. This whitepaper sets out what each method is good for, how to choose between them and what a robust interface to the ISO 14971 risk analysis has to do.

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Case Studies

Annex 1 Compliance in Sterile Manufacturing
Case Study

Annex 1 Compliance in Sterile Manufacturing

An international pharmaceutical company specializing in sterile products had to align its processes and systems with the new requirements of Annex 1 of the EU GMP Guidelines.

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Audit Software Integration for Improved Production Quality under GMP
Case Study

Audit Software Integration for Improved Production Quality under GMP

An international software provider in the regulated life sciences environment needed a robust internal audit system to monitor production processes in line with GMP and reduce regulatory risk.

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Audit Support: Securing Reliable Audit Results
Case Study

Audit Support: Securing Reliable Audit Results

Provision of independent, experienced auditors to conduct audits to GMP and ISO standards, including report writing and CAPA follow-up.

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Readiness Checks & Tools

Check6 questions

EUDAMED Readiness Check

6 questions, 3 minutes: how far along is your EUDAMED registration really, and where do typical gaps block you?

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Check3 questions

AI Act × MDR Trilemma Check

3 questions: does your AI software fall under the EU AI Act as a high-risk system, on top of MDR/IVDR?

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Check12 questions

EU AI Act Readiness Check

12 questions, 6 minutes: your AI is classified as high-risk, or you suspect it is. How far are your Art. 8-15 records really?

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Regulatory Update Hub

12 short expert videos on the MDR/IVDR revision, free after a one-time registration.

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Trade fairs we attend as participants and where we take meeting requests, plus our own training sessions. A short message is enough and we will agree on a slot.

  • CPhI Milan 2026

    Team Pharma

    Milan, ItalyOctober 6–8, 2026
    Find out more →

  • RAPS AI in Regulatory Conference 2026

    Team Medical Devices

    Barcelona, SpainNovember 5–6, 2026
    Find out more →

  • DCAT Week 2027

    Team Pharma

    New York, United StatesMarch 15–18, 2027
    Find out more →

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