![Top 30 MDCG Guidance Documents for Medical Device Companies-1]()
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!
FREE EBOOK: Click here to download a PDF version of the Top 30 MDCG Guidance Documents for Medical Device Companies.
Table of contents
|
Reference
|
Title
|
|
MDCG 2022-5
|
Guidance on borderline between medical devices and medicinal products under Regulation (EU) 2017/745 on medical devices
|
|
MDCG 2021-24
|
Guidance on classification of medical devices
|
|
MDCG 2021-28
|
Substantial modification of clinical investigation under Medical Device Regulation
|
|
MDCG 2021-6
|
Regulation (EU) 2017/745 – Questions & Answers regarding clinical investigation
|
|
MDCG 2020-8
|
Guidance on PMCF evaluation report template
|
|
MDCG 2020-7
|
Guidance on PMCF plan template
|
|
MDCG 2020-6
|
Guidance on sufficient clinical evidence for legacy devices
|
|
MDCG 2020-5
|
Guidance on clinical evaluation – Equivalence
|
|
MDCG 2020-13
|
Clinical evaluation assessment report template
|
|
MDCG 2019-9 rev. 1
|
Summary of safety and clinical performance
|
|
MDCG 2021-3
|
Questions and answers on custom-made devices
|
|
MDCG 2021-1 rev. 1
|
Guidance on harmonised administrative practices and alternative technical solutions until EUDAMED is full functional
|
|
MDCG 2019-5
|
Registration of legacy devices in EUDAMED
|
|
MDCG 2022-16
|
Guidance on Authorised Representatives Regulation (EU) 2017/745 and Regulation (EU) 2017/746
|
|
MDCG 2021-26
|
Q&A on repackaging and relabelling activities under Article 16 of Regulation (EU) 2017/745 and Regulation (EU) 2017/746
|
|
MDCG 2020-16 rev. 1
|
Guidance on classification rules for in vitro diagnostic medical devices under Regulation (EU) 2017/746
|
|
MDCG 2022-2
|
Guidance on general principles of clinical evidence for in vitro diagnostic medical devices (IVDs)
|
|
MDCG 2022-8
|
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
|
|
SaMD Infographic
|
Is your software a medical device?
|
|
MDCG 2020-1
|
Guidance on clinical evaluation (MDR) / Performance evaluation (IVDR) of medical device software
|
|
MDCG 2019-16 rev.1
|
Guidance on cybersecurity for medical devices
|
|
MDCG 2019-11
|
Qualification and classification of software - Regulation (EU) 2017/745 and Regulation (EU) 2017/746
|
|
MDCG 2019-6 rev.4
|
Questions and answers: Requirements relating to notified bodies
|
|
MDCG 2020-3
|
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
|
|
MDCG 2019-13
|
Guidance on the sampling of devices for the assessment of the technical documentation
|
|
MDCG 2022-21
|
Guidance on the Periodic Safety Update Report (PSUR) according to Regulation (EU) 2017/745
|
|
MDCG 2021-19
|
Guidance on integration of the UDI within an organization’s quality management system
|
|
MDCG 2018-1 rev. 4
|
Guidance on basic UDI-DI and changes to UDI-DI
|
|
MDCG 2018-5
|
UDI assignment to medical device software
|
|
MDCG 2019-7
|
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)
|
MDCG 2022-5
Guidance on borderline between medical devices and medicinal products under Regulation (EU) 2017/745 on medical devices
What’s in this guidance? This guidance includes a discussion of the borderline between medical devices and medicinal products, along with definitions and examples of each. It includes chapters on herbal products, substance-based medical devices, and medical device and medicinal product combinations.
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
MDCG 2021-24
Guidance on classification of medical devices
What’s in this guidance? This guidance includes information on the purpose of medical device classification and its practical relevance, as well as guidance on how to carry out classification and apply the classification rules in EU MDR.
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
MDCG 2021-28
Substantial modification of clinical investigation under Medical Device Regulation
What’s in this guidance? The document includes a template for notifying an EU Member State of any substantial modification to a clinical investigation that is likely to have a substantial impact on the safety, heath, or rights of the subjects, or on the robustness or reliability of the clinical data generated by the investigation.
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
MDCG 2021-6
Regulation (EU) 2017/745 – Questions & Answers regarding clinical investigation
What’s in this guidance? This document contains a series of common questions and answers regarding clinical investigations and their regulation under EU MDR.
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
MDCG 2020-8
Guidance on PMCF evaluation report template
What’s in this guidance? The guidance contains templates that are meant to guide manufacturers as they compile their post-market clinical follow-up (PMCF) evaluation report.
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
MDCG 2020-7
Guidance on PMCF plan template
What’s in this guidance? The document includes a template to help manufacturers comply with EU MDR requirements while they are compiling their PMCF plan.
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
MDCG 2020-6
Guidance on sufficient clinical evidence for legacy devices
What’s in this guidance? This document provides guidance on what data provide sufficient clinical evidence necessary for demonstrating a legacy device’s conformity with the relevant General Safety and Performance Requirements (GSPRs) of EU MDR.
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
MDCG 2020-5
Guidance on clinical evaluation – Equivalence
What’s in this guidance? This document offers information on demonstrating equivalence with another medical device already on the market for the purpose of obtaining a CE marking under EU MDR.
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
MDCG 2020-13
Clinical evaluation assessment report template
What’s in this guidance? This document includes a template for a clinical evaluation assessment report, which is used by notified bodies to document the assessment of clinical evidence presented by the manufacturer in their clinical evaluation report (CER).
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
MDCG 2019-9 rev. 1
Summary of safety and clinical performance
What’s in this guidance? This document is meant to provide guidance on the presentation, content, and validation of the summary of safety and clinical performance (SSCP), a document manufacturers of implantable devices and Class III devices are required to draw up. It also includes a SSCP template.
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
MDCG 2021-3
Questions and answers on custom-made devices
What’s in this guidance? This document offers a high-level overview of custom-made devices through a series of general questions and answers.
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
MDCG 2021-1 rev. 1
Guidance on harmonised administrative practices and alternative technical solutions until EUDAMED is full functional
What’s in this guidance? The document offers guidance on the application of specific EU MDR provisions in the absence of a fully functioning EUDAMED.
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
MDCG 2019-5
Registration of legacy devices in EUDAMED
What’s in this guidance? This document includes information on how to register legacy devices in EUDAMED without the Basic UDI-DI.
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
MDCG 2022-16
Guidance on Authorised Representatives Regulation (EU) 2017/745 and Regulation (EU) 2017/746
What’s in this guidance? This document provides guidance on the use of authorized representatives in Member States where a manufacturer is not established, as well as the relevant requirements under EU MDR and EU IVDR.
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
MDCG 2021-26
Q&A on repackaging and relabelling activities under Article 16 of Regulation (EU) 2017/745 and Regulation (EU) 2017/746
What’s in this guidance? This document includes a series of questions and answers regarding economic operators who are carrying out the relabelling and/or repackaging of devices and their obligations under Article 16 of EU MDR and EU IVDR.
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
MDCG 2020-16 rev. 1
Guidance on classification rules for in vitro diagnostic medical devices under Regulation (EU) 2017/746
What’s in this guidance? This document provides information on determining the risk class of an IVD under EU IVDR, including clarification of the classification rules laid out in Annex VIII of the regulation.
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
MDCG 2022-2
Guidance on general principles of clinical evidence for in vitro diagnostic medical devices (IVDs)
What’s in this guidance? This document lays out the general principles of clinical evidence and offers guidance on the continuous process of performance evaluation for IVDs set down in EU IVDR.
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
MDCG 2022-8
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
What’s in this guidance? This document provides information on the applicability of EU IVDR requirements to legacy devices that were placed on the market prior to May 26, 2022 (the regulation’s date of applicability).
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
SaMD Infographic
Is your software a medical device?
What’s in this guidance? The document consists of a flow chart to help manufacturers understand whether their product is Medical Device Software (MDSW) and what regulation (if any) it is covered by.
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?
MDCG 2020-1
Guidance on clinical evaluation (MDR) / Performance evaluation (IVDR) of medical device software
What’s in this guidance? This document includes guidance on determining the appropriate level of clinical evidence required for Medical Device Software (MDSW) to fulfill the requirements of EU MDR and EU IVDR regarding clinical evaluation and performance evaluation, respectively.
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
MDCG 2019-16 rev. 1
Guidance on cybersecurity for medical devices
What’s in this guidance? This document offers guidance to manufacturers on how to fulfill all the relevant requirements for cybersecurity in Annex I of EU MDR and EU IVDR. It also includes references to other cybersecurity legislation and guidance.
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
MDCG 2019-11
Qualification and classification of software - Regulation (EU) 2017/745 and Regulation (EU) 2017/746
What’s in this guidance? This document defines the criteria that are used for qualifying software that falls under the scope of EU MDR and EU IVDR. It also includes information related to the placing of those products on the market.
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
MDCG 2019-6 rev. 4
Questions and answers: Requirements relating to notified bodies
What’s in this guidance? This document consists of a series of questions and answers about the role of notified bodies under EU MDR and EU IVDR.
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
MDCG 2020-3
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
What’s in this guidance? This document provides guidance on what changes to a device are considered “significant changes” under Article 120(3) of EU MDR. The document also includes a series of flowcharts that are meant to clarify the decision-making process.
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
MDCG 2019-13
Guidance on the sampling of devices for the assessment of the technical documentation
What’s in this guidance? This document defines the requirements for the sampling Class IIa and Class IIb devices under EU MDR, as well as the sampling of Class B and Class C IVDs under EU IVDR in order to assess technical documentation.
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
MDCG 2022-21
Guidance on the Periodic Safety Update Report (PSUR) according to Regulation (EU) 2017/745
What’s in this guidance? This document provides an overview of the Periodic Safety Update Report (PSUR), including general considerations, scope and duration, and the preparation and issuance of the report.
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
MDCG 2021-19
Guidance on integration of the UDI within an organization’s quality management system
What’s in this guidance? This document provides guidance on how medical device manufacturers can integrate the UDI requirements in EU MDR and EU IVDR into their quality management system to ensure traceability and enhance post-market surveillance activities.
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
MDCG 2018-1 rev. 4
Guidance on basic UDI-DI and changes to UDI-DI
What’s in this guidance? This document provides clarification on the concept of Basic UDI-DI, its use in relevant documentation, and the factors that trigger changes to UDI-DI.
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
MDCG 2018-5
UDI assignment to medical device software
What’s in this guidance? This document provides guidance related to some specific considerations on UDI that manufacturers of Medical Device Software (MDSW) should take into account.
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
MDCG 2019-7
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)
What’s in this guidance? This document provides clarification on the role and responsibilities of the person responsible for regulatory compliance (PRRC) as defined in the EU MDR and IVDR.
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
FREE EBOOK: Click here to download a PDF version of the Top 30 MDCG Guidance Documents for Medical Device Companies.
De-risk your business with a turnkey QMS solution built for medical devices
Regulations in the medical device industry can be complicated, to say the least. But that doesn’t mean the tools you use to comply with those regulations have to be complex or difficult to use.
At Greenlight Guru, we offer the only QMS platform designed by medical device professionals specifically for medical device professionals. No added complications—just everything you need to stop worrying about compliance and focus on building the safest, most effective medical devices possible.
If you’re ready to see what a purpose-built QMS can do for your medical device company, then get your free demo of Greenlight Guru today!
