A fundamental part of safeguarding patients in Europe comes from ensuring that medical devices and in vitro diagnostics (IVDs) meet consistent, high regulatory standards. Under the EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR), those standards are shaped by detailed legislation.
That’s where MDCG guidance—issued by the Medical Device Coordination Group—comes in. It explains and clarifies how regulators expect the MDR/IVDR to be interpreted and applied in practice across EU member states.
The reason why MDCG Documents are so important is simple: conformity assessment. The documents ensure each medical device meets a certain standard by verifying that the standard in question is applied in all aspects of manufacturing.
In this post, I’ll explain what MDCG guidance is, what it covers, and how it impacts your MDR/IVDR compliance. We’ll also provide practical suggestions on how to monitor and implement new MDCG guidance updates if you’re new to MDR/IVDR compliance.
Key takeaways
What is MDCG guidance?
MDCG guidance documents are official, though non-legally binding, interpretative documents endorsed by the Medical Device Coordination Group under Article 105 of the MDR and Article 99 of the IVDR.
The guidance documents created by the MDCG are drafted collaboratively and formally endorsed at the EU level, representing the common understanding of EU Member State authorities on how the regulations should be applied in practice. Competent Authorities expect them to be followed, which is why Notified Bodies reference them so frequently during audits.
Essentially, MDCG guidance documents include details and clarifications that turn complex regulatory text into something operational. For manufacturers, authorities, and Notified Bodies alike, they serve as a practical bridge between legislation and implementation. In practice, I’ve seen MDCG guidance shape expectations around clinical evaluation, post-market surveillance, classification, and more.
Who issues MDCG guidance and why it matters
The MDCG itself was established by the MDR and is composed of experts from each EU Member State—specialists in medical devices and IVDs— who are appointed for defined terms. It plays a central role in harmonising the implementation of the MDR/IVDR by monitoring technical progress across the medical device and IVD industries, contributing to standards development, and assessing Notified Bodies.
What do MDCG documents cover
MDCG guidance documents cover a range of topics, namely:
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Annex XVI products
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Borderline and Classification
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Class I Devices
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Clinical investigation and evaluation
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Performance studies and evaluation
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COVID-19
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Custom-Made Devices
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EUDAMED
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European Medical Device Nomenclature (EMDN)
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Implant cards
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In-house devices
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Authorised Representatives
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Importers
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Distributors
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Article 10a – interruption or discontinuation of supply
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In Vitro Diagnostic medical devices (IVD)
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New technologies
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Notified bodies
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Person responsible for regulatory compliance (PRRC)
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Post-Market Surveillance and Vigilance (PMSV)
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Standards
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Unique Device Identifier (UDI)
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Other topics
Key areas covered by MDCG guidance
The MDCG documents go into quite a bit of detail. Below you’ll find a summary of what’s covered, but it’s best to look at each section—and the corresponding reference codes—individually to familiarise yourself with detailed compliance requirements.
While beneficial, it is important to note that the MDCG documents have at times drawn extensive criticism. This is mostly because the process behind the scenes is rather opaque. Some claim the guidance documents lack patient representation, while others believe the definition of legal liability is too vague, with some Notified Bodies evaluating manufacturers based on the MDCG Documents beyond the scope of the pertinent directives.
How MDCG guidance impacts your MDR compliance
MDCG guidance documents act as crucial, practical tools for MDR/IVDR compliance across clinical investigations and evaluations, software and technology, legacy devices, and conformity assessments. Some documents are compliance roadmaps, others are FAQ documents or best practices for safety.
The biggest benefits of MDCG guidance are:
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Convenience for the manufacturer, helping them be audit-ready far more easily than referring directly to the MDR/IVDR, which can be confusing and vague. Essentially, they give manufacturers a harmonised, best practices interpretation of the MDR/IVDR across all EU member states' National Competent Authorities (regulators). As you can imagine, this makes things an awful lot easier to manufacture and distribute devices across the bloc!
- Reduced risk of issues during audits by Notified Bodies (independent, third-party organisations that assess medical device compliance with regulatory requirements). By reducing the number of audit queries following inspections, manufacturers can potentially avoid losing their CE certification, which is a necessary requirement to sell medical devices and IVDs in the EU.
Let’s look at some concrete examples:
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Clinical Investigation and Post-Market Clinical Follow-Up (PMCF) example: The MDCG guides manufacturers on requirements for Clinical Investigation Plans (CIP) and PMCF studies, including collecting and assessing safety and performance data, and any exemptions.
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Medical Device Software (MDS) example: In the case of medical apps, there is specific guidance for whether an app platform qualifies as a distributor of MDS, along with a compliance roadmap.
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Legacy (old) devices transition example: MDCG 2021-25 defines that legacy devices can continue to be placed on the market until 31 December 2027 or 2028 (depending on risk class) if they do not undergo significant changes and comply with specific MDR requirements.
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Technical documentation: The MDCG guidance follows Good Documentation Practices and gives details on the required technical documentation and how to create, update, and store it so that it is audit-ready across the key areas.
Recent and ongoing MDCG guidance updates
MDCG guidance updates occur regularly, making it essential for manufacturers and distributors to keep up to date.
MDCG guidance 2026 news
As of January 2026, there are two new decisions on the harmonisation of standards under the MDR/IVDR being implemented by the European Commission. These harmonised standards cover various topics, including the clinical investigation and evaluation of medical devices, neurosurgical implants, non-active surgical implants, and the sterilisation of health care products.
MDCG guidance 2025 news
A number of MDCG documents published in 2025 represent substantive guidance updates:
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MDCG 2025-10: Guidance on post-market surveillance of medical devices and IVDs
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MDCG 2025-9: Guidance on Breakthrough Devices (BtX)
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MDCG 2025-6: FAQ on MDR/IVDR and the Artificial Intelligence Act
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MDCG 2025-5: Questions & Answers on performance studies for IVDs
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MDCG 2025-4: Guidance on the safe making available of medical device software (MDSW) apps on online platforms
Practical EUDAMED guide for QA and RA teams.
How to monitor and implement new MDCG guidance
Published guidance: MDCG guidance has reference numbers that make it easy to see if you’re missing one from your files. The format is as follows: MDCG [year]-[number]. For example, the first new guidance document published in 2025 had a reference number MDCG 2025-1. You can download the documents from the European Commission website page on MDCG guidance.
Latest updates: There’s also a handy section at the end for ‘Latest Updates’ specifically relating to MDCG guidance. Additionally, there’s a dedicated page for the latest updates on the Medical Devices Sector as a whole, which has an RSS feed, meaning that you can be notified of the latest update alerts in real-time.
Upcoming publications: It’s a good idea to keep an eye on what guidance is being developed or revised, so that you’re aware of when it should be published. The MDCG provides a publication plan to show what upcoming MDCG guidance documents they expect to publish and when.
How a digital QMS helps manage regulatory guidance
For medical device and IVD manufacturers and distributors operating in Europe, keeping up with evolving MDCG guidance is no longer just a regulatory exercise; it’s an operational one.
Guidance updates influence how you structure your clinical evaluation reports, how you document post-market surveillance activities, how you prepare for notified body audits, and even how you manage software, AI components, and EUDAMED registrations. The challenge isn’t just understanding new requirements—it’s embedding them into your day-to-day processes in a controlled, traceable way.
That’s where a digital QMS makes the difference.
At Scilife, our Smart QMS platform helps you centralise, maintain, and continuously update your regulatory documentation in line with the latest MDCG guidance documents and EU MDR/IVDR expectations.
Instead of manually tracking guidance changes across spreadsheets and disconnected systems, you can integrate regulatory updates directly into controlled processes and document workflows.
With the right QMS software, you can:
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Keep audit-ready technical documentation accessible at all times
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Create and manage structured regulatory projects
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Update document templates in line with new MDCG guidance updates
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Define required file contents at project initiation
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Automatically populate documents with approved content
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Maintain full version history and change traceability
A fully digital, customizable QMS allows you to move from reactive compliance to proactive regulatory management—saving time, reducing risk, and giving your team confidence during inspections and audits.
Find out more about Scilife Smart QMS for Medical Devices and IVDs.
