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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
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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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Development & Strategy

PFAS fluoropolymers in medical devices: what the FDA's 2026 position means for manufacturers
Article

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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From Digital Measurement to Regulatory Evidence
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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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Market Access

Real-World Evidence in Benefit Assessment: Where It Counts
Article

Real-World Evidence in Benefit Assessment: Where It Counts

The G-BA and IQWiG do not accept routine-care data as a substitute for randomized trials, yet at one clearly defined point they explicitly require it: the application-accompanying data collection under Section 35a(3b) SGB V. Knowing the difference means planning registries before authorization instead of after the decision.

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The German Reimbursement Amount Is Decided in the Study Design
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The German Reimbursement Amount Is Decided in the Study Design

From the seventh month after market launch, the negotiated reimbursement amount applies. By then the negotiation is no longer about the price but about the consequences of a decision taken long before. And what limits the headroom changed on 30 July 2026: the guardrails in Section 130b(3) SGB V have been restructured and the combination discount is gone.

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JCA and AMNOG: The EU Assessment Does Not Replace the German One
Article

JCA and AMNOG: The EU Assessment Does Not Replace the German One

Joint clinical assessments have applied to oncology medicines and ATMPs since 12 January 2025. They do not replace the German benefit assessment under Section 35a SGB V. Added benefit, the appropriate comparator therapy and the price stay national. What changes is timing: the EU dossier falls due before marketing authorisation is granted.

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Regulatory Affairs

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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MDR Meets the EU AI Act: The Trilemma for AI Software
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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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FMEA or FTA? Why Choosing the Method Will Not Save Your Risk Analysis
Article

FMEA or FTA? Why Choosing the Method Will Not Save Your Risk Analysis

In many MedTech projects, the first question is which method to use for the risk analysis. That question falls short: quality is not determined by the method, but by the fit between the question, the method, and integration into the logic of ISO 14971.

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Quality & Compliance

FDA Inspections Under QMSR: What Program 7382.850 Changes
Article

FDA Inspections Under QMSR: What Program 7382.850 Changes

Since 2 February 2026 the FDA no longer inspects under QSIT but under Compliance Program 7382.850. More consequential than the new procedure, though, is a change in the regulatory text: the protection for management review, internal audits and supplier audit reports is gone.

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QMSR: What Actually Changes for an ISO 13485 QMS
Article

QMSR: What Actually Changes for an ISO 13485 QMS

Since 2 February 2026, 21 CFR Part 820 has been the Quality Management System Regulation and incorporates ISO 13485:2016 by reference. A certificate is therefore the foundation, not the conformity: the FDA additions sit in three places, and inspections have followed a different program since the same day.

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Computer System Validation: Two New Standards, One 12-Week Window
Article

Computer System Validation: Two New Standards, One 12-Week Window

The revised Annex 11 is in final consultation. Annex 22 sits alongside it in draft: the EU's first dedicated guidance on AI in GMP manufacturing. Read them side by side and the message is the same. The bar for trusting a computerised system is moving up.

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Supply & TechOps

Quality Agreements With Critical Suppliers
Article

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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PPWR: Why Pharma Packaging Is Not Exempt
Article

PPWR: Why Pharma Packaging Is Not Exempt

"Pharma is exempt from PPWR" is the assumption most likely to fail an audit. The Article 6(11) exemption covers primary packaging, and cartons only where they preserve product quality. The rest is in scope. General application: 12 August 2026.

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What manual visual inspection really costs
Article

What manual visual inspection really costs

We fully costed a completed AVI project: 89 inspectors replaced by two automated systems, 4.2 million euro in annual savings, ROI in under 2 years.

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

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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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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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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
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  • RAPS AI in Regulatory Conference 2026

    Team Medical Devices

    Barcelona, SpainNovember 5–6, 2026
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  • DCAT Week 2027

    Team Pharma

    New York, United StatesMarch 15–18, 2027
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