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.

ICH M4 (Common Technical Document, structure of Modules 1 to 5)

eCTD Publishing & Regulatory Operations →

eCTD publishing and regulatory operations for pharma, biotech, medtech and IVD: building and maintaining the eCTD backbone, lifecycle operations across sequences, technical validation before filing, dispatch through the FDA ESG and CESP, and archiving under 21 CFR Part 11.

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)

EU Market Access for US Manufacturers →

EU market access for US medical device, IVD and pharmaceutical manufacturers that already hold an FDA clearance or approval: gap analysis of the existing submission against MDR and IVDR evidence requirements, the authorised representative mandate under Art. 11, technical documentation to Annex II and III, EUDAMED registration and notified body selection.

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 authorisation 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 GMP Guide, Chapter 7 (outsourced activities: contract giver, contract acceptor, written agreement)

Interim & Functional Sourcing →

Interim staffing, team extension and functional sourcing for pharma, biotech, medtech and IVD: named specialists for vacancies, capacity alongside the internal team, and taking over defined processes, with a written agreement under Chapter 7 of the EU GMP Guide and a clear split of responsibilities.

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).

EU 2017/746 (IVDR)

IVD Consulting & IVDR Readiness →

IVDR consulting for IVD manufacturers: portfolio classification under Annex VIII, performance evaluation under Art. 56 and Annex XIII, technical documentation, transition strategy under Art. 110, and support through the notified body, across all classes A to D.

EU 2017/745 (MDR) Annex I Section 23 (label and instructions for use)

Labeling & IFU →

Labeling and IFU development for MedTech and IVD: compliance review against MDR Annex I Section 23 and IVDR Annex I Section 20, symbology per ISO 15223-1, multilingual IFUs and eIFU strategy per Regulation (EU) 2021/2226, traceable to the technical documentation.

Regulation (EC) No 1234/2008 (examination of variations to marketing authorizations)

Lifecycle Management & Variations →

Lifecycle maintenance for pharma, biotech, medtech and IVD: classifying, grouping and filing variations under Regulation (EC) No 1234/2008, renewals and PSURs, US supplements under 21 CFR 314.70, and change assessment under the MDR and IVDR with the notified body.

Regulation (EC) No 1394/2007 (ATMP Regulation)

Marketing authorisation for ATMPs & Biologics →

Regulatory support for ATMPs and biologics: ATMP classification at the CAT, authorization strategy for the centralized EMA procedure, CMC strategy in line with the GMP requirements for biologics and ATMPs, Scientific Advice, and Hospital Exemption advice for non-routinely manufactured ATMPs at academic institutions.

EU 2017/745 (MDR)

MDR Conformity →

MDR consulting for medical device manufacturers: gap analysis, technical documentation under Annex II/III, clinical evaluation under Annex XIV and support through the notified body - across all classes from I to III.

EU 2017/745 (MDR) Art. 87 (reporting of serious incidents and FSCA)

Medical Device Vigilance →

Vigilance consulting for MedTech and IVD: building the vigilance system, incident assessment and MIR preparation, trend reporting, and coordination of FSCA and authority communication under MDR Art. 87 et seq. and IVDR Art. 82 et seq.

Directive 2001/83/EC (Community code relating to medicinal products for human use)

Pharmacovigilance →

Pharmacovigilance consulting for marketing authorisation holders: PSMF set-up under GVP Module II, ICSR/SAE management with Eudravigilance reporting, signal management under Module IX, RMP under Module V and PSUR under ICH E2C(R2), across the entire product lifecycle.

EU 2017/745 (MDR)

PMCF Services →

PMCF consulting for medical device manufacturers under the MDR (EU 2017/745): a device-specific PMCF plan per Annex XIV Part B, selection and implementation of the PMCF method (registries, surveys, retrospective analyses) and preparation of the PMCF evaluation report to feed into the clinical evaluation.

EU 2017/745 (MDR)

Post-Market Surveillance →

Building PMS systems for MedTech and IVD: a PMS plan under MDR Annex III, a PSUR under Art. 86, PMCF under Annex XIV and the IVDR equivalents under EU 2017/746, as an ongoing system connected to risk management and vigilance.

Directive 2001/83/EC Art. 51 (obligations of the Qualified Person, batch certification)

QP on Demand →

Qualified Person on Demand for pharma and biotech: batch release under Art. 51 Directive 2001/83/EC and §16 AMWHV, import release, interim QP to bridge vacancies, and project-based QP expertise for inspections and remediation.

Directive 2001/83/EC Art. 104 (MAH's QPPV obligation, continuous availability)

QPPV Services →

QPPV as outsourcing, interim, or backup: an EU-resident Qualified Person for Pharmacovigilance with a written mandate under GVP Module I, responsible for the PSMF and authority communication with the EMA and national authorities.

EU 2017/745 (MDR)

Regulatory & Compliance →

Regulatory and compliance consulting for life sciences across all four domains for pharma, biotech, MedTech and IVD: market authorization and regulatory strategy, quality management and audits, post-market surveillance and vigilance, and IT-supported compliance processes.

EU 2017/745 (MDR)

Regulatory Affairs →

Regulatory affairs consulting for Pharma, Biotech, MedTech and IVD: regulatory strategy and authority communication, dossier preparation (CTD/eCTD, technical documentation), submission management and lifecycle management under the AMG, EMA procedures, MDR (EU 2017/745) and IVDR (EU 2017/746), also available as interim resourcing.

ISO 14971:2019 (Application of risk management to medical devices)

Risk Management →

Risk management in accordance with ISO 14971:2019 for medical devices and IVDs: hazard and risk analysis, risk acceptability criteria, the Risk Management File, and post-production risk review as the basis for MDR and IVDR conformity.

Regulation (EU) No 726/2004 (PV obligations, EU marketing authorisations)

Signal Detection →

Signal detection for marketing authorisation holders: a documented signal management process in line with GVP Module IX - data sources, disproportionality analysis on EudraVigilance, signal validation and prioritization, and reporting to the EMA and national authorities, anchored in the PSMF.

EU 2017/745 (MDR)

Technical Documentation & UDI →

Development and maintenance of MDR-compliant technical documentation per Annex II/III: GSPR checklist per Annex I, UDI implementation per Art. 27 and EUDAMED registration per Art. 29 - for all device classes I through III.

EU 2017/745 (MDR) Annex II/III (technical documentation)

Technical Writing →

Technical writing for regulated life science products: technical documentation under MDR/IVDR Annex II/III, IFU compliant with ISO 15223 and IEC 62366, and GMP SOPs, linked consistently to risk management and clinical evaluation.

UK Medical Devices Regulations 2002 (SI 2002/618), as amended

UKCA Marking & Great Britain Access →

UKCA strategy for manufacturers who already hold a CE certificate: the time limited acceptance of CE marked devices in Great Britain, UK Responsible Person and MHRA registration, the post-market surveillance duties introduced by SI 2024/1368, conformity assessment by a UK Approved Body, and the separate rules that apply in Northern Ireland.

Regulatory Affairs

30 topics in Regulatory Affairs

CE Marking →

Change Management →

Clinical Compliance →

DiGA Approval →

eCTD Publishing & Regulatory Operations →

EU AI Act →

EU Market Access for US Manufacturers →

EUDAMED →

FDA Clearance & Approval →

Health Authority Interaction →

Interim & Functional Sourcing →

International Market Access →

IVD Consulting & IVDR Readiness →

Labeling & IFU →

Lifecycle Management & Variations →

Marketing authorisation for ATMPs & Biologics →

MDR Conformity →

Medical Device Vigilance →

Pharmacovigilance →

PMCF Services →

Post-Market Surveillance →

QP on Demand →

QPPV Services →

Regulatory & Compliance →

Regulatory Affairs →

Risk Management →

Signal Detection →

Technical Documentation & UDI →

Technical Writing →

UKCA Marking & Great Britain Access →

Which topic is relevant for your project right now?

Projects in this area

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

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

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

Current articles

The UK Health Bill and a potential Great Britain medical-device licensing regime

AI in Medical Technology: The Interplay of AI Act, MDR and IVDR

QMSR: What Actually Changes for an ISO 13485 QMS

Other areas

A concrete project in this area?