The Medical Device Coordination Group (MDCG) is a regulatory body made up of industry experts appointed by each of the member states of the European Union.
Broadly speaking, the goal of the MDCG is to help ensure that both EU MDR and EU IVDR are implemented efficiently and effectively. To that end, the MDCG has put out over 100 guidance documents for medical device manufacturers, notified bodies, and other stakeholders.
The MDCG guidance documents elaborate on and clarify various aspects of EU MDR and EU IVDR, and they’re an invaluable resource for anyone involved in placing devices on the market in the EU.
While we encourage you to check out the full list of MDCG guidance documents, this blog provides you with a list of our top 30 MDCG guidance documents—the documents that are most often searched for and/or widely applicable across device types and risk classes.
Use this list to find the MDCG’s answers to some of the most-asked questions about EU MDR and IVDR. Happy scrolling!
Reference
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Title
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Guidance on borderline between medical devices and medicinal products under Regulation (EU) 2017/745 on medical devices |
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Guidance on classification of medical devices |
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Substantial modification of clinical investigation under Medical Device Regulation |
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Regulation (EU) 2017/745 – Questions & Answers regarding clinical investigation |
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Guidance on PMCF evaluation report template |
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Guidance on PMCF plan template |
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Guidance on sufficient clinical evidence for legacy devices |
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Guidance on clinical evaluation – Equivalence |
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Clinical evaluation assessment report template |
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Summary of safety and clinical performance |
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Questions and answers on custom-made devices |
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Guidance on harmonised administrative practices and alternative technical solutions until EUDAMED is full functional |
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Registration of legacy devices in EUDAMED |
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Guidance on Authorised Representatives Regulation (EU) 2017/745 and Regulation (EU) 2017/746 |
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Q&A on repackaging and relabelling activities under Article 16 of Regulation (EU) 2017/745 and Regulation (EU) 2017/746 |
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Guidance on classification rules for in vitro diagnostic medical devices under Regulation (EU) 2017/746 |
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Guidance on general principles of clinical evidence for in vitro diagnostic medical devices (IVDs) |
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Regulation (EU) 2017/746 - application of IVDR requirements to ‘legacy devices’ and to devices placed on the market prior to 26 May 2022 in accordance with Directive 98/79/EC |
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Is your software a medical device? |
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Guidance on clinical evaluation (MDR) / Performance evaluation (IVDR) of medical device software |
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Guidance on cybersecurity for medical devices |
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Qualification and classification of software - Regulation (EU) 2017/745 and Regulation (EU) 2017/746 |
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Questions and answers: Requirements relating to notified bodies |
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Guidance on significant changes regarding the transitional provision under Article 120 of the MDR with regard to devices covered by certificates according to MDD or AIMDD |
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Guidance on the sampling of devices for the assessment of the technical documentation |
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Guidance on the Periodic Safety Update Report (PSUR) according to Regulation (EU) 2017/745 |
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Guidance on integration of the UDI within an organization’s quality management system |
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Guidance on basic UDI-DI and changes to UDI-DI |
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UDI assignment to medical device software |
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Guidance on article 15 of the medical device regulation (MDR) and in vitro diagnostic device regulation (IVDR) on a ‘person responsible for regulatory compliance’ (PRRC) |
Who is this guidance for? Anyone who is unsure of whether their product is a medical device or a medicinal product and needs to understand which regulations will govern their product.
Category: Borderline and Classification
Publication date: April 2022
Link to guidance: MDCG 2022-5
Who is this guidance for? Any manufacturer who is planning on marketing their medical device in the EU and needs to know what risk class their device falls under.
Category: Borderline and Classification
Publication date: October 2021
Link to guidance: MDCG 2021-24
Who is this guidance for? Any sponsor of a clinical investigation that needs to notify a Member State of a substantial modification of their clinical investigation. Once the EUDAMED module on Clinical Investigation & Performance Studies is ready, notification of substantial modification to a clinical investigation will occur through EUDAMED.
Category: Clinical investigation and evaluation
Publication date: December 2021
Link to guidance: MDCG 2021-28
Who is this guidance for? Sponsors of clinical investigations of medical devices that are being carried out under EU MDR.
Category: Clinical investigation and evaluation
Publication date: April 2021
Who is this guidance for? Any medical device manufacturer that is required to perform a PMCF and compile the data in a PMCF evaluation report.
Category: Clinical investigation and evaluation
Publication date: April 2020
Who is this guidance for? Any medical device manufacturer that is required to perform a PMCF can use this document to help them compile their PMCF plan in a manner that complies with EU MDR.
Category: Clinical investigation and evaluation
Publication date: April 2020
Link to guidance: MDCG 2020-7
Who is this guidance for? Manufacturers of legacy devices that were CE marked under the MDD or AIMDD and now must undergo the conformity assessment procedure according to EU MDR.
Category: Clinical investigation and evaluation
Publication date: April 2020
Link to guidance: MDCG 2020-6
Who is this guidance for? Medical device manufacturers who want to use data from an existing device on the market for the purpose of CE marking, and need to demonstrate equivalence with that device.
Category: Clinical investigation and evaluation
Publication date: April 2020
Link to guidance: MDCG 2020-5
Who is this guidance for? Notified bodies that need to clearly document the outcome of their assessment of a manufacturer’s CER. The template may also be useful to manufacturers who want to better understand how their CER will be assessed.
Category: Clinical investigation and evaluation
Publication date: July 2020
Link to guidance: MDCG 2020-13
Who is this guidance for? Both manufacturers who need to create SSCPs and the notified bodies that will review the documents.
Category: Clinical investigation and evaluation
Publication date: March 2022
Who is this guidance for? Manufacturers of custom-made devices or those who want to know if their device falls under the category of custom-made.
Category: Custom-made devices
Publication date: March 2021
Who is this guidance for? Member states, notified bodies, and manufacturers who need to meet their obligations under EU MDR while various EUDAMED modules are still being developed.
Category: EUDAMED
Publication date: May 2021
Link to guidance: MDCG 2021-1 rev. 1
Who is this guidance for? Manufacturers of legacy devices that will continue to be placed on the market after the EU MDR date of application.
Category: EUDAMED
Publication date: April 2019
Link to guidance: MDCG 2019-5
Who is this guidance for? Authorized representatives, manufacturers, and any other economic operators who need to understand the role of the authorized representative and the regulatory requirements they operate under.
Category: Authorized Representatives, Importers, Distributors
Publication date: October 2022
Link to guidance: MDCG 2022-16
Who is this guidance for? Any economic operators engaged in repackaging or relabelling activities who need to understand and clarify their obligations under the Regulations.
Category: Authorized Representatives, Importers, Distributors
Publication date: October 2021
Link to guidance: MDCG 2021-26
Who is this guidance for? Manufacturers and notified bodies that need to understand how to classify an IVD before it is placed on the market, as well as regulators and other stakeholders who need to assess the class attributed to an IVD.
Category: In vitro diagnostic medical devices (IVD)
Publication date: January 2022
Who is this guidance for? Manufacturers, investigators, and study sponsors of IVDs in the EU.
Category: In vitro diagnostic medical devices (IVD)
Publication date: January 2022
Link to guidance: MDCG 2022-2
Who is this guidance for? Manufacturers with legacy devices that need to know which IVDR requirements are applicable to their devices.
Category: In vitro diagnostic medical devices (IVD)
Publication date: May 2022
Link to guidance: MDCG 2022-8
Who is this guidance for? Any software manufacturer who is unsure of how their product will be classified in the EU.
Category: New technologies
Publication date: March 2021
Link to guidance: Is your software a medical device?
Who is this guidance for? Manufacturers of MDSW that need to understand what type of clinical evidence their product will require to comply with EU MDR or EU IVDR.
Category: New technologies
Publication date: March 2020
Link to guidance: MDCG 2020-1
Who is this guidance for? Medical device manufacturers in the EU whose devices include any risks related to cybersecurity, including those that incorporate electronic programmable systems and those that are MDSW.
Category: New technologies
Publication date: December 2019
Link to guidance: MDCG 2019-16 rev. 1
Who is this guidance for? Manufacturers or developers of software that are unsure of whether their product will be categorized as Medical Device Software (MDSW) and subject to regulation under EU MDR or EU IVDR.
Category: New technologies
Publication date: October 2019
Link to guidance: MDCG 2019-11
Who is this guidance for? Notified bodies and anyone who wants to better understand their role under the Regulations.
Category: Notified bodies
Publication date: October 2022
Link to guidance: MDCG 2019-6 rev. 4
Who is this guidance for? Manufacturers and notified bodies who need to understand whether a change to a given device will constitute a significant change under EU MDR.
Category: Notified bodies
Publication date: March 2020
Link to guidance: MDCG 2020-3
Who is this guidance for? Notified bodies that need clarification on the sampling requirements for their assessment of the technical documentation of a manufacturer’s medical device.
Category: Notified bodies
Publication date: December 2019
Link to guidance: MDCG 2019-13
Who is this guidance for? Manufacturers of devices that require a PSUR, which includes all risk classes except Class I devices.
Category: Post-Market Surveillance and Vigilance (PMSV)
Publication date: December 2022
Link to guidance: MDCG 2022-21
Who is this guidance for? Manufacturers with questions about the UDI requirements in the Regulations and how they should implement them.
Category: Unique Device Identifier (UDI)
Publication date: July 2021
Link to guidance: MDCG 2021-19
Who is this guidance for? Manufacturers who are new to the concept of Basic UDI-DI and want to get a basic understanding of what it is and how it works.
Category: Unique Device Identifier (UDI)
Publication date: April 2021
Link to guidance: MDCG 2018-1 rev. 4
Who is this guidance for? Manufacturers of MDSW who need to understand how UDI rules apply to their software and what to consider in regards to UDI when making changes to software.
Category: Unique Device Identifier (UDI)
Publication date: October 2018
Link to guidance: MDCG 2018-5
Who is this guidance for? Manufacturers who are unclear as to their obligations when it comes to the PRRC or a PRRC themselves who want to gain more clarity about their role.
Category: Other topics
Publication date: June 2019
Link to guidance: MDCG 2019-7
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Etienne Nichols is a Medical Device Guru and Mechanical Engineer who loves learning and teaching how systems work together. He has both manufacturing and product development experience, even aiding in the development of combination drug-delivery devices, from startup to Fortune 500 companies and holds a Project...