Documents & Templates Tools & Ressources

EU MDCG Guidance Library for Medical Devices and IVD Regulations

October 2, 2025
H RA

The European Commission maintains a comprehensive online collection of Medical Device Coordination Group (MDCG) endorsed guidance documents and related resources. These materials help manufacturers, notified bodies, and other stakeholders apply the EU Medical Device Regulation (MDR) and In Vitro Diagnostic Medical Device Regulation (IVDR) consistently. While not legally binding, the documents reflect a shared interpretation of compliance requirements, support harmonised implementation, and provide templates and practical tools for regulatory work.

In this article:

What is the purpose of the guidance collection?

The MDCG endorsed guidance documents are drafted with input from regulatory experts and industry stakeholders. Their aim is to clarify how MDR and IVDR rules should be applied in practice. They outline standardised approaches, offer interpretive notes, and provide templates that support efficient and compliant processes across the EU market. Each document follows an MDCG year-number-revision format and is periodically reviewed for updates or archiving.

Who should use this resource?

The resource is relevant to manufacturers of medical devices and in vitro diagnostic devices, authorised representatives, importers, distributors, notified bodies, health institutions, and regulatory consultants. It also benefits healthcare providers procuring or using regulated devices. Any organisation responsible for compliance under MDR or IVDR will find actionable material in this collection.

What topics are covered?

The library is organised into thematic categories. Key areas include:

  • Annex XVI products: Guidance on qualification, classification, and transitional provisions for devices without an intended medical purpose.
  • Borderline and classification: Manuals and notes to determine whether a product meets the definition of a medical device or falls under medicinal product rules.
  • Clinical investigation and evaluation: Detailed guidance on study protocols, exemptions, safety reporting, and clinical evidence requirements.
  • COVID-19 related documents: Advice for manufacturers on performance evaluation, conformity assessment procedures, and regulatory requirements for pandemic-response devices.
  • Custom-made and in-house devices: Q&A style documents explaining specific regulatory exemptions.
  • EUDAMED and nomenclature: Instructions on registration, nomenclature updates, and administrative practices pending full database functionality.
  • Implant cards and patient information: Guidance on device type categorisation and mandatory implant cards.
  • Authorised representatives, importers, distributors: Clarification of Articles 13 and 14 obligations and related activities such as repackaging and relabelling.
  • Article 10a supply interruption notifications: Forms and Q&A on informing authorities about device supply changes.
  • In vitro diagnostic devices: Classification, safety templates, and transitional provisions under IVDR.
  • New technologies: Guidance on software, AI applications, cybersecurity, and hardware-software combinations.
  • Notified body operations: Templates, designation procedures, sampling guidance, and surveillance practices.
  • Post-market surveillance and vigilance: Templates for device-specific vigilance guidance and periodic safety update reports.
  • Standards and UDI: Guidance on integrating Unique Device Identifiers into quality systems and standardisation activities.
  • Other regulatory notices: Position papers, transitional period Q&A, and legacy device guidance.
  • Language requirements and external agency notes: Country-specific instructions, EMA guidance, and scientific opinion documents.

FAQ

  1. Are these guidance documents legally binding?
    No. They serve as interpretive aids and common practice references but do not replace the obligations in MDR or IVDR.
  2. How often are the documents updated?
    They are reviewed regularly and may be revised or archived when no longer current.
  3. Where can obsolete guidance be found?
    An archived section is available through the same European Commission site, labelled “obsolete guidance”.
  4. What format are the documents provided in?
    Most are available in PDF, some include Word or Excel templates.

Key takeaways

This EU-managed guidance library is a central reference point for MDR and IVDR application. By following MDCG endorsed formats and recommendations, stakeholders can align with EU-wide practices, prepare compliant documentation, and stay informed on evolving regulatory interpretations. Each category addresses a specific compliance area from device classification to post-market oversight.

Disclaimer

This article is informational. The author is not affiliated with the European Commission or the Medical Device Coordination Group. Always refer to the full official texts for complete requirements.

For more information, visit: https://health.ec.europa.eu/medical-devices-sector/new-regulations/guidance-mdcg-endorsed-documents-and-other-guidance_en