Skip to content
Entourage

Area of expertise

Regulatory Affairs

Regulatory affairs keeps a product marketable across its entire lifecycle: conformity under MDR (EU 2017/745), IVDR (EU 2017/746) and pharmaceutical law, from the technical documentation and notified-body engagement through EUDAMED registration and labeling to vigilance and post-market surveillance. We run submissions and authority interactions so that market access never fails on formal gaps.

  • Biotech
  • IVD
  • MedTech
  • Pharma

All topics

25 topics in Regulatory Affairs

EU 2017/745 (MDR)

CE Marking →

CE marking for medical devices under EU 2017/745: classification under Annex VIII, choice of conformity assessment route, technical documentation under Annex II/III, notified body support and declaration of conformity, across all classes from I to III.

ICH Q10 (Pharmaceutical Quality System), Change Management System (Section 3.2.3)

Change Management →

Building and reviewing GMP-compliant change control systems for pharma, biotech, medtech and IVD: risk assessment under ICH Q9(R1), regulatory impact assessment, variation classification under Regulation (EC) No 1234/2008 and change control for validated IT systems under GAMP 5.

ICH E6(R3) (Good Clinical Practice)

Clinical Compliance →

Clinical compliance for sponsors: GCP gap analysis in line with ICH E6, clinical audits at investigator sites and CROs, TMF build-up and review based on the DIA TMF Reference Model, plus inspection readiness for inspections by the FDA, EMA and national authorities.

Sec. 33a SGB V (Digital Health Applications)

DiGA Approval →

DiGA approval consulting for the BfArM procedure: eligibility check under Sec. 33a SGB V, study design for the positive healthcare effect, data security preparation per BSI TR-03161 and an AbEM (application-accompanying outcome measurement) concept aligned with the 2026 DiGAV amendment, for both the fast-track and the regular procedure.

Regulation (EU) 2024/1689 (EU AI Act)

EU AI Act →

EU AI Act consulting for AI in medical devices, IVDs and GxP processes: high-risk classification under Art. 6, obligations under Art. 8 to 15, technical documentation under Annex IV, plus integration with MDR (EU 2017/745), IVDR (EU 2017/746) and the draft GMP Annex 22 on AI.

EU 2017/745 (MDR) Art. 33 (EUDAMED)

EUDAMED →

EUDAMED consulting for MedTech and IVD companies: actor registration (SRN), UDI data management, certificate linking, and preparation of vigilance and PMS processes for the EUDAMED reporting channels under MDR Art. 33 and IVDR Art. 30.

FD&C Act Sec. 513(i) (Substantial Equivalence)

FDA Clearance & Approval →

Guidance through US market access for medical devices: classification and pathway selection, predicate strategy and substantial equivalence under FD&C Act Sec. 513(i), pre-submission meetings (Q-Sub), 510(k) submission in the eSTAR template, as well as De Novo and PMA procedures, including US Agent and QMSR preparation.

Regulation (EC) No 726/2004 (EMA, centralized marketing authorization procedure, scientific advice)

Health Authority Interaction →

Preparation and support of health authority interactions for pharma, biotech, medtech & IVD: scientific advice and meetings with the EMA and FDA, applications and variations to national authorities such as BfArM and Swissmedic, as well as inspection and CAPA communication.

EU 2017/745 (MDR)

International Market Access →

International approval strategies for pharma, biotech, MedTech and IVD: prioritizing target markets, the FDA pathways 510(k), De Novo and PMA, registrations with PMDA, NMPA, ANVISA and GCC authorities, and third-country compliance for the UK (UKCA) and Switzerland (MepV).

Next step

Which topic is relevant for your project right now?

Use our free readiness checks for a first assessment, or talk to a specialist directly, without obligation.

Get in touch →Free readiness checks →
  • 100% life sciences
  • 500+ projects completed
  • Reply usually within one working day

Case Studies

Projects in this area

All case studies →
Case StudyIVD

Global Market Access After the IVDR Transition: 100 Percent On-Time TGA Submissions

Following the transition to the IVDR, a diagnostics manufacturer had to meet pressing compliance deadlines set by the Australian Therapeutic Goods Administration, with limited internal capacity and diverging requirements across multiple international markets.

IVD diagnostics manufacturer with international distribution

Case StudyMedTech

Regulatory Strategy for 510(k) Clearance and Successful US Market Entry

An international MedTech manufacturer was preparing to enter the US market on a fixed timeline and had no experience with FDA requirements. Entourage developed the regulatory strategy for the 510(k) clearance.

An international MedTech manufacturer

Case StudyIVD

IVDR Certification for Class C and Class D IVDs: Complete Annex II/III Documentation

An IVD manufacturer faced critical IVDR deadlines for its Class D products, with limited internal capacity for the extensive regulatory, clinical and analytical requirements and insufficient evidence for the conformity assessment.

Manufacturer of in-vitro diagnostics in risk classes C and D

Insights

Current articles

All insights →
Article

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.

EU AI Act (Regulation 2024/1689)

Article

EUDAMED Readiness: Why Registrations Fail in Practice

Since 28 May 2026, the first four EUDAMED modules are mandatory: actors, UDI and devices, notified bodies and certificates, market surveillance. Legacy devices must be registered by 28 November 2026. Four problem clusters we encounter time and again.

EU 2017/745 (MDR) Art. 33 (EUDAMED)

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.

21 CFR Part 820 (Quality Management System Regulation, QMSR, since 2 February 2026)

Other areas

Product Development & Regulatory Strategy

From classification and regulatory strategy through to development and study planning.

Market Access, RWE & Reimbursement

Market access, health economics, real-world evidence and pricing and reimbursement strategy.

Quality Management & Compliance

QM systems, audits, computer system validation and data integrity under ISO 13485, GMP and 21 CFR Part 11.

Supply Chain & Technical Operations

Supply chain, manufacturing, shortage management and technical operations optimization.

Your project

A concrete project in this area?

Briefly outline your situation. We'll respond with an initial assessment, usually within one business day.

Prefer direct? +49 89 4161170-0
info@theentourage.de

  • Reply usually within one working day
  • 4 offices: DE · CH · IT · US
  • 100% life sciences