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Expert articles from project practice.

Articles, news, tools and whitepapers, with regulatory references instead of buzzwords.

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Webinar · Practical insight for IVD manufacturersNov 4, 2026

Automate technical documentation and introduce AI under control

Free webinar with Confideck for IVD manufacturers: automate technical documentation and introduce AI under control, with a live look. In German.

Article

FDA finalizes new 510(k) guidance for dental composite resins and dental curing lights

News

RAPS AI in Regulatory Conference 2026: Entourage Is in Barcelona

Article

The EU AI Act for Life Sciences: When AI Counts as High-Risk

Latest news

News & Updates

RAPS AI in Regulatory Conference 2026: Entourage Is in Barcelona
News

RAPS AI in Regulatory Conference 2026: Entourage Is in Barcelona

On November 5 and 6, 2026, RAPS brings regulatory professionals to Barcelona to look at what artificial intelligence is doing to regulatory work. Entourage is there on both days.

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

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

From March 15 to 18, 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
News

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

September 11 and 12, 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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Analysis & knowledge

Articles & Whitepapers

Development & Strategy

Beyond the CTD: What European Manufacturers Should Know Before an ANDA Submission in the US
Article

Beyond the CTD: What European Manufacturers Should Know Before an ANDA Submission in the US

For European manufacturers, the US market offers significant opportunities, but successful market entry requires more than transferring an existing European dossier into a US submission. Manufacturers should assess the regulatory pathway, reference product, patent landscape, bioequivalence strategy and US-specific CMC documentation requirements early.

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Verification and validation: what MDR Annex II Section 6, ISO 13485 Clause 7.3 and the QMSR since February 2, 2026 require as evidence
Article

Verification and validation: what MDR Annex II Section 6, ISO 13485 Clause 7.3 and the QMSR since February 2, 2026 require as evidence

Three texts define what V&V evidence must look like, and they only fit together when the documentation is built from the requirements downward. MDR Annex II Section 6 requires the results and critical analyses of all verification and validation tests together with complete protocols; ISO 13485:2016 separates design and development verification from design and development validation in Clause 7.3 and requires process validation in 7.5.6; the FDA's QMSR has incorporated that very standard by reference since February 2, 2026, and lists the old QSR subsections as reserved. Drug manufacturers work against Annex 15 in addition, with its chain from URS to PQ. What is written where, with the exact references.

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Clinical Monitoring: Sponsor Oversight under CTR Art. 71 and ICH E6(R3)
Article

Clinical Monitoring: Sponsor Oversight under CTR Art. 71 and ICH E6(R3)

Delegating clinical monitoring to a CRO transfers tasks, not responsibility: Art. 71 of Regulation (EU) No 536/2014 leaves it with the sponsor. What GCP inspections found most often in monitoring between 2022 and 2024 shows exactly where that responsibility breaks down in practice.

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Market Access

Medical Science Liaison Before Approval: Where Law and Codes Draw the Line to Promotion
Article

Medical Science Liaison Before Approval: Where Law and Codes Draw the Line to Promotion

Promoting a medicinal product that has no marketing authorization is prohibited; answering a specific question is permitted. Between those two sentences lies the work of the Medical Science Liaison in the months before launch. The line is drawn neither by the job title nor by the department but by the wording of Article 86 of Directive 2001/83/EC, Section 1(5) and Section 3a of the German Heilmittelwerbegesetz (HWG), and, alongside them, Section 75 of the German Arzneimittelgesetz (AMG), which covers every person who, commissioned by a pharmaceutical company and as a main occupation, visits healthcare professionals to inform them about medicinal products. This article lays the texts side by side, together with Sections 18 and 27 of the FSA Code, Articles 15 and 20 of the EFPIA Code and the sponsor rules of Regulation (EU) No 536/2014 for investigator-initiated trials.

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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
Article

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 July 30, 2026: the guardrails in Section 130b(3) SGB V have been restructured and the combination discount is gone.

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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
Article

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

Contamination Control Strategy under Annex 1: what paragraphs 2.3 to 2.6 require of the CCS
Article

Contamination Control Strategy under Annex 1: what paragraphs 2.3 to 2.6 require of the CCS

The revised EU GMP Annex 1 requires, in paragraph 2.3, a Contamination Control Strategy across the whole facility that defines all critical control points and assesses the effectiveness of all controls. Existing systems may stay, but they must be referenced and their interactions understood. In our reading, a CCS that merely lists measures does not meet the second part.

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Process validation: what Annex 15, the FDA and ICH Q7 actually say about the number of batches
Article

Process validation: what Annex 15, the FDA and ICH Q7 actually say about the number of batches

Three validation batches are the rule of thumb, and the texts are more precise: Annex 15 section 5.20 names three consecutive batches as generally acceptable and section 5.19 requires every number to be justified, ICH Q7 names three as a guide, the EMA guideline requires data on at least three production scale batches only where the dossier needs production scale data (biologicals, non-standard processes), and the FDA guidance of 2011 names no number at all. What follows for the validation master plan, the PPQ protocol and ongoing process verification.

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FDA Inspections Under QMSR: What Program 7382.850 Changes
Article

FDA Inspections Under QMSR: What Program 7382.850 Changes

Since February 2, 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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Supply & TechOps

Changing a Supplier Under GMP: What Chapters 5 and 7 Require Before the First Order
Article

Changing a Supplier Under GMP: What Chapters 5 and 7 Require Before the First Order

A supplier change starts in purchasing and, when it goes wrong, ends in an inspection report. The EU GMP Guide treats the procurement of starting materials as part of the pharmaceutical quality system: Chapter 5 requires documented supplier qualification, audits for active substances, a formalized risk assessment for excipients, and it ties reduced testing to the history with that particular supplier. For outsourced GMP activities, not for every material supplier, Chapter 7 and Article 12 of Directive (EU) 2017/1572 require the written contract before anything is outsourced. This article walks through the text.

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Lean in the QC Laboratory: What Chapter 6 of the EU GMP Guide Fixes and What 5S and Scheduling May Change
Article

Lean in the QC Laboratory: What Chapter 6 of the EU GMP Guide Fixes and What 5S and Scheduling May Change

Whoever brings 5S into a quality control laboratory meets requirements older than any lean initiative: Chapter 6 of the EU GMP Guide, in its current version since October 1, 2014, says what the label of a reagent should show (section 6.21), that laboratory equipment is not routinely moved between high risk areas (section 6.5) and that results are recorded in a manner permitting trend evaluation (section 6.9). Annex 19 in the revision applicable since September 24, 2026, says how long reference and retention samples should be kept and that analytical materials and equipment for all tests in the specification should remain available, or readily obtainable, until one year after expiry of the last batch. This article walks through the places where lean meets GMP, along the text.

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Regulatory due diligence: the deadlines and registers against which a data room is measured (MDR Art. 120, IVDR Art. 110, EUDAMED, Art. 16 and 10a)
Article

Regulatory due diligence: the deadlines and registers against which a data room is measured (MDR Art. 120, IVDR Art. 110, EUDAMED, Art. 16 and 10a)

A data room shows what the target company produces. Whether that is enough is decided by the legal text: MDR Art. 120 ties continued sales under an MDD certificate to May 26, 2024, and September 26, 2024, IVDR Art. 110 sets staggered dates up to 2027, EUDAMED has been mandatory in four modules since May 28, 2026, and Art. 16 MDR turns a buyer who sells the device under its own name after closing into the manufacturer with all obligations. There are also three public registers: EudraGMDP, the EUDAMED module "Notified Bodies & Certificates" and the FDA Warning Letter database. What a regulatory due diligence has to establish per device, with references.

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Tools

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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?

Start check →

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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Video & whitepaper library

Regulatory Update Hub

19 short expert videos and 2 whitepapers on the MDR/IVDR revision, free after a one-time registration.

Explore the Regulatory Update Hub

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Events

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