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What Are the MDCG Documents and Why Are They Important

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How much do you know about Medical Device Coordination Group Documents?

You may be more familiar with their abbreviation: MDCG.

Developed on behalf of the European Commission, MDCG Documents are designed to help manufacturers understand how the Medical Device Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR) should be applied to medical devices with an effective and harmonized implementation of European legislation. In addition, the guidance documents are a useful source for device manufacturers, notified bodies, and other authorities.

MDCG Documents play a key role in the life sciences space, where conformity assessment is vital. This article will discuss what exactly these documents are and why they are so important. Continue reading for a full breakdown.

What Are MDCG Documents?

In the life sciences, MDCG Documents outline common approaches that manufacturers and notified bodies ought to follow in their conformity assessment procedures (specifically to meet MDR 2017/745 requirements).

These documents are written by the MDCG, composed of authorities in the European public health space. More specifically, MDCG consists of stakeholders appointed by member states based on their role and expertise in medical devices. The group aims to advise the EU Commission and contribute to the consistent implementation of medical devices.

It is important to note that the MDCG documents are simply guidelines—they are not legally binding. However, most stakeholders still expect manufacturers to follow them. The goal is to ensure the consistent, uniform application of directive provisions when developing medical devices.

MEDDEV documents were used under the MDD. Now, they are being superseded by MDCG guidance documents under the MDR and IVDR, which is a part of the transition from MDD to the new MDR.

32 MDCG documents were published in 2021, and 27 new MDCG documents have been published in 2022 at the time of this writing. More MDCG documents are increasingly being applied for. Topics like the Unique Device Identifier and the EUDAMED database are new for manufacturers and are only addressed by the MDCG guides.

 

What Do MDCG Documents Cover?

MDCG Documents feature specific reference codes. In addition, documents are drafted and denominated by the following format: “MDCG Year-Number-revision.”

The documents are endorsed at the Medical Device Coordination Group’s plenary meetings and cover a range of topics, including:

  • Borderline and classification
  • Class I devices
  • Clinical investigation and evaluation
  • COVID-19
  • Custom devices
  • EUDAMED database
  • European medical device nomenclature
  • Implant cards
  • Importers and Distributors
  • In vitro diagnostic medical devices
  • New technologies
  • Notified bodies
  • Standards
  • Unique Device Identifier
  • Other topics
  • Other guidance documents

 

Below, you’ll find an extensive list of the main MDCG Documents split by topics. Skip it here, and go to the next section “What Stakeholders work with MDCG Documents”.

 

Topic

Reference

Title

Publication

Borderline and Classification

MDCG 2022-5

Guidance on borderline between medical devices and medicinal products under Regulation (EU) 2017/745 on medical devices

April 2022

MDCG 2021-24

Guidance on classification of medical devices

October 2021

Class I Devices

MDCG 2020-2

Rev.1

Class I transitional provisions under Article 120 (3 and 4) – (MDR)

March 2020

MDCG 2019-15

Rev.1

Guidance notes for manufacturers of class I medical devices

December 2019

Clinical investigation and evaluation

MDCG 2021-28

Substantial modification of clinical investigation under Medical Device Regulation

December 2021

MDCG 2021-20

Instructions for generating CIV-ID for MDR Clinical Investigations

July 2021

MDCG 2021-8

Clinical investigation application/notification documents

May 2021

MDCG 2021-6

Regulation (EU) 2017/745 – 

Questions & Answers regarding clinical investigation

April 2021

MDCG 2020-13

Clinical evaluation assessment report template

July 2020

MDCG 2020-10/2

MDCG 2020-10/1

Guidance on safety reporting in clinical investigations

Appendix: Clinical investigation summary safety report form

May 2020

MDCG 2020-8

Guidance on PMCF evaluation report template

April 2020

MDCG 2020-7

Guidance on PMCF plan template

April 2020

MDCG 2020-6

Guidance on sufficient clinical evidence for legacy devices

April 2020

MDCG 2020-5

Guidance on clinical evaluation – Equivalence

April 2020

MDCG 2019-9 

Rev.1

Summary of safety and clinical performance

March 2022

COVID-19

MDCG 2022-1

Notice to 3rd country manufacturers

of SARS-CoV-2 in vitro diagnostic medical devices

January 2022

MDCG 2022-21

Rev.1

Guidance on performance evaluation of SARS-CoV-2

in vitro diagnostic medical devices

August 2021

MDCG 2021-7

Notice to manufacturers and authorized representatives on the impact of genetic variants on SARS-COV-2

in vitro diagnostic medical devices

May 2021

MDCG 2021-2

Guidance on state of the art of COVID-19 rapid antibody tests

March 2021

COVID-19 TESTS: Q&A on in vitro diagnostic medical device conformity assessment and performance in the context of COVID-19

February 2021

Conformity assessment procedures for protective equipment

July 2020

How to verify that medical devices and personal protective equipment can be lawfully placed on the EU market and thus purchased and used – also in the COVID-19 context

May 2020

Guidance on regulatory requirements for medical face masks

June 2020

Guidance on medical devices, active implantable medical devices and in vitro diagnostic medical devices in the COVID-19 context

April 2020

Conformity assessment procedures for 3D printing and 3D printed products to be used in a medical context for COVID-19

April 2020

MDCG 2020-9

Regulatory requirements for ventilators and related accessories

April 2020

Custom-Made Devices

MDCG 2021-3

Questions and Answers on Custom-Made Devices

March 2021

EUDAMED

MDCG 2021-13

Rev.1

Questions and answers on obligations and related rules for the registration in EUDAMED of actors other than manufacturers, authorized representatives and importers subject to the obligations of Article 31 MDR and Article 28 IVDR

July 2021

MDCG 2021-1

Rev.1

Guidance on harmonized administrative practices and alternative technical solutions until EUDAMED is fully functional

May 2021

MDCG 2020-15

MDCG Position Paper on the use of the EUDAMED actor registration module and of the Single Registration Number (SRN) in the Member States

August 2020

MDCG 2019-5

Registration of legacy devices in EUDAMED

April 2019

MDCG 2019-4

Timelines for registration of device data elements in EUDAMED

April 2019

European Medical Device Nomenclature (EMDN)

MDCG 2021-12

FAQ on the European Medical Device Nomenclature (EMDN)

June 2021

The EMDN – The nomenclature of use in EUDAMED

January 2020

The CND nomenclature – Background and general principles

January 2020

MDCG 2018-2

Future EU medical device nomenclature - Description of requirements

March 2018

Implant cards

MDCG 2021-11

Guidance on Implant Card – Device types

May 2021

MDCG 2019-8 

v2

Guidance document implant card on the application of Article 18 Regulation (EU) 2017/745 on medical devices 

March 2020

Importers & Distributors

MDCG 2021-27

Questions and Answers on Articles 13 & 14 of Regulation (EU) 2017/745 and Regulation (EU) 2017/746

December 2021

MDCG 2021-26

Q&A on repackaging & relabeling activities under Article 16 of Regulation (EU) 2017/745 and Regulation (EU) 2017/746

October 2021

In Vitro Diagnostic medical devices (IVD)

MDCG 2022-10

Q&A on the interface between Regulation (EU) 536/2014 on clinical trials for medicinal products for human use (CTR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR)

May 2022

MDCG 2022-9

Summary of safety and performance template

May 2022

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

May 2022

MDCG 2022-6

Guidance on significant changes regarding the transitional provision under Article 110(3) of the IVDR

May 2022

MDCG 2022-3

Verification of manufactured class D IVDs by notified bodies

February 2022

MDCG 2022-2

Guidance on general principles of clinical evidence for In Vitro Diagnostic medical devices (IVDs)

January 2022

MDCG 2021-22

Clarification on “first certification for that type of device” and corresponding procedures to be followed by notified bodies, in context of the consultation of the expert panel referred to in Article 48(6) of Regulation (EU) 2017/746

August 2021

MDCG 2021-4

Application of transitional provisions for certification of class D in vitro diagnostic medical devices according to Regulation (EU) 2017/746

April 2021

MDCG 2020-16 

Rev.1

Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746

January 2022

New technologies

Infographic

Is your software a Medical Device?

March 2021

MDCG 2020-1

Guidance on clinical evaluation(MDR) /Performance evaluation(IVDR) of medical device software

March 2020

MDCG 2019-16 

Rev.1

Guidance on cybersecurity for medical devices

December 2019

MDCG 2019-11

Qualification and classification of software- Regulation (EU) 2017/745 and Regulation (EU) 2017/746

October 2019

Notified bodies

MDCG 2022-4

Guidance on appropriate surveillance regarding the transitional provisions under Article 120 of the MDR with regard to devices covered by certificates according to the MDD or the AIMDD

February 2022

MDCG 2019-6 

Rev.3

Questions and answers: Requirements relating to notified bodies

October 2021

MDCG 2021-23

Guidance for notified bodies, distributors and importers on certification activities in accordance with Article 16(4) of Regulation (EU) 2017/745 and Regulation (EU) 2017/746

August 2021

MDCG 2021-18

Applied-for scope of designation and notification of a conformity assessment body– Regulation (EU) 2017/746 (IVDR)

July 2021

MDCG 2021-17

Applied-for scope of designation and notification of a conformity assessment body– Regulation (EU) 2017/745 (MDR)

July 2021

MDCG 2021-16

Application form to be submitted by a conformity assessment body when applying for designation as notified body under the in vitro diagnostic devices regulation (IVDR)

July 2021

MDCG 2021-15

Application form to be submitted by a conformity assessment body when applying for designation as notified body under the medical devices regulation (MDR)

July 2021

MDCG 2021-14

Explanatory note on IVDR codes

July 2021

MDCG 2020-17

Questions and Answers related to MDCG 2020-4:

December 2020

“Guidance on temporary extraordinary measures related to medical device notified body audits during COVID-19 quarantine orders and travel restrictions”

MDCG 2020-14

Guidance for notified bodies on the use of MDSAP audit reports in the context of surveillance audits carried out under the Medical Devices Regulation (MDR)/In Vitro Diagnostic medical devices Regulation (IVDR)

August 2020

MDCG 2020-12

Guidance on transitional provisions for consultations of authorities on devices incorporating a substance which may be considered a medicinal product and which has action ancillary to that of the device, as well as on devices manufactured using TSE susceptible animal tissues

June 2020

MDCG 2020-11

Guidance on the renewal of designation and monitoring of notified bodies under Directives 90/385/EEC and 93/42/EEC to be performed in accordance with Commission Implementing Regulation (EU) 2020/666 amending Commission Implementing Regulation (EU) 920/2013

May 2020

MDCG 2020-4

Guidance on temporary extraordinary measures related to medical device notified body audits during COVID-19 quarantine orders and travel restrictions

April 2020

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

March 2020

MDCG 2019-14

Explanatory note on MDR codes

December 2019

MDCG 2019-13

Guidance on sampling of devices for the assessment of the technical documentation

December 2019

MDCG 2019-12

Designating authority's final assessment form: Key information (EN)

October 2019

MDCG 2019-10 

Rev.1

Application of transitional provisions concerning validity of certificates issued in accordance with the directives

October 2019

MDCG 2018-8

Guidance on content of the certificates, voluntary certificate transfers

November 2018

Standards

MDCG 2021-5

Guidance on standardization for medical devices

April 2021

Unique Device Identifier (UDI)

MDCG 2022-7

Q&A on the Unique Device Identification system under Regulation (EU) 2017/745 and Regulation (EU)

May.22

MDCG 2021-19

Guidance note integration of the UDI within an organization’s quality management system

July 2021

MDCG 2021-10

The status of Appendixes E-I of IMDRF N48 under the EU regulatory framework for medical devices

June 2021

MDCG 2021-09

MDCG Position Paper on the Implementation of UDI requirements for contact lenses, spectacle frames, spectacle lenses & ready readers

May.21

MDCG 2018-1 

Rev. 4

Guidance on basic UDI-DI and changes to UDI-DI

April 2021

MDCG 2020-18

MDCG Position Paper on UDI assignment for Spectacle lenses & Ready readers

December 2020

MDCG 2019-2

Guidance on application of UDI rules to device-part of products referred to in article 1(8), 1(9) and 1(10) of Regulation 745/2017

February 2019

MDCG 2019-1

MDCG guiding principles for issuing entities rules on basic UDI-DI

January 2019

MDCG 2018-7

Provisional considerations regarding language issues associated with the UDI database

October 2018

MDCG 2018-6

Clarifications of UDI related responsibilities in relation to article 16

October 2018

MDCG 2018-5

UDI assignment to medical device software

October 2018

MDCG 2018-4

Definitions/descriptions and formats of the UDI core elements for systems or procedure packs

October 2018

MDCG 2018-3 

Rev.1

Guidance on UDI for systems and procedure packs

June 2020

Other topics

MDCG 2021-25

Application of MDR requirements to "legacy devices" and to devices placed on the market prior to 26 May 2021 in accordance with Directives 90/385/EEC or 93/42/EEC

October 2021

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)

June 2019

MDCG 2019-3 rev.1

Clinical evaluation consultation procedure exemptions Interpretation of article 54(2)b

April 2020

 

The MDCG Documents go into quite a bit of detail. It’s best to look at each section—and the corresponding reference codes—individually in order to optimize your familiarity with the concepts and your conformity assessment procedures.

 

What Stakeholders Work with MDCG Documents?

A variety of stakeholders contributed to drafting the MDCG Documents. They are chosen for their professional experience and competency in the medical device industry. The entire committee has about 60 members. Key parties in the development of these documents include:

 

  • European Commission
  • Notified bodies
  • Standardization bodies
  • European member state authorities



Why Are MDCG Documents Important?

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.

The idea of conformity assessment is to create consistent, replicable results. This offers benefits such as:

 

  • Consumer confidence
  • Competitive edge
  • Regulator peace of mind

 

As the MDCG Documents show, conformity assessment incorporates a range of techniques, including testing, inspection, validation, and verification. These activities may result in different standards of conformity.

 

Why Does Conformity Assessment Matter?

Conformity assessment determines whether the device manufacturing process meets the requirements described in a given standard or specification. In the case of the MDCG Documents, this standard is composed of the documents themselves. In short, this is why conformity assessment is crucial:

 

  • Governments can verify the safety of a medical device and better protect constituents from unnecessary risk.
  • Insurers can rest assured that manufacturers have mitigated risks and addressed safety concerns in their devices.
  • Investors can enjoy an added layer of security.
  • Consumers can gain proof of the device’s safety, reliability, and performance.

 

This benefits consumers, regulators, suppliers, and the manufacturers. It allows manufacturers to prove their device meets the relevant safety and performance standards while giving other parties confidence in the marketplace. Surely, not all medical devices undergo the most stringent conformity assessment procedures. But MDCG Documents offer a reasonable conformity assessment framework so that all manufacturers can at the very least ensure a certain degree of replicability.

 

Key Considerations

While beneficial, it is important to note that the MDCG Documents have drawn extensive criticism from time to time. 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.

While the MDCG Documents support manufacturers by specifying regulatory requirements, many stand firm in their belief that there needs to be more clarity.

Although medical devices play a key role in the regulatory landscape in the European Union, the process is not seamless for life sciences companies. However, addressing—and preventing—nonconformity is key in healthcare.

In this way, MDCG Documents can help manufacturers navigate all factors involved in bringing high-quality, researched-backed products to market. And MDCG Documents do, in fact, increase companies’ regulatory efforts. From risk-benefit analysis to data accessibility, manufacturers must pay attention to all facets of the MDCG Documents when developing their medical devices.

 

Next Steps

Do you have questions about the MDCG Documents? Is your Life Sciences organization searching for more insight into quality control, replicability, governance, and conformity assessment?

Connect with us for details, and discover how Scilife can help you keep all your documents under control!

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