Everything You Need To Know About Medical Device Coordination Group (MDCG)
The Medical Device Coordination Group (MDCG) is a regulatory body of health and industry experts with the goal to improve medical device coordination, ensuring the safe and effective use of medical devices in Europe. The group is mainly known for publishing MDCG guidance starting with the series MDCG 2019. Such guidance can be perceived as EU MDR guidance documents.
MDCG was developed under the MDR (Medical Device Regulation) and IVDR (In-vitro-Diagnostic Device Regulation) to ensure that hospitals, clinics, managed care organizations, health systems, and other entities can coordinate their procurement strategies for medical devices in order to increase efficiency.
The MDCG guidance provides information about the provisions that must be addressed for the implementation of the new EU Medical Devices Regulation. While the guidance is not legally binding, it implements Article 105 of the EU MDR intended for the harmonized and effective execution of the regulation.
The regulatory body typically includes physicians, nurses, health care providers, pharmacists, quality-of-care experts, and other stakeholders who work together to improve patient safety with medical device usage.
Keep on reading as we explore MDCG in detail.
What are the Tasks of the MDCG?
Please note that MDCG has no decision-making power and boasts only advisory and coordinating functions. They deal with the major challenges from the medical devices sector, including standardization to market surveillance, Notified Body Oversight, new technologies, and clinical investigation, and passing by international matters.
MDCG’s expertise originates from its divisions in 13 subgroups that provide advice and draft MDCG guidance on their respective fields.
MDCG directly reports to the EU Commission. Its primary role and responsibility include:
- Defining details of the reporting system from Article 91, which includes deadlines and measures, etc.
- Common Specifications adopted, with reference to Article 9
- Decides whether a medical device falls within the scope of the regulation, with respect to Article 4 and Article 51
They create a market surveillance program where they can request scientific advice on the performance and safety of a medical device from the expert panels in case there are any concerns.
Who Can Become a Member of MDCG?
The Medical Devices Coordination Group is composed of a panel appointed by the Member States based on their role and expertise in medical devices. Their goal is to advise the EU Commission and contribute to the uniform implementation of medical products and devices. It supports medical devices, which includes in-vitro diagnostics as well.
The members of the Medical Device Coordination Group are chosen for their professional experience and competency in medical devices, as well as diagnostics. The entire committee has about 60 members overall so that no one area gets overlooked during the decision-making process. That is, each Member State of the European Union appoints a member and deputy member.
In an effort to better understand the safety and efficacy of medical devices, the Medical Device Coordination Group can invite third parties like individuals or companies to attend meetings. Additionally, they may ask these groups for written input on specific topics related to the device use.
Essentially, they can include physicians, nurses, health care providers, pharmacists, quality-of-care experts, and other stakeholders.
Notified Bodies Oversight
MDCG shares experiences and exchanges perspectives on challenges related to notified bodies. Hence, they draft technical recommendations on matters related to conformity assessment and notified bodies. The topics of interest include conformity assessment activities, cooperation among authorities responsible for notified bodies, and coordination of administrative practice.
Standards
MDCG discusses challenges related to standardization and coordinates proposals for the development and use of specific and technical standard documents in diverse fields. It deals with topics related to standardization requests to the European standardization organizations, availability of harmonized standards in the context of the preparation of common specifications, International Medical Device Regulators Forum., and cooperation with the European (CEN and Cenelec) and international (ISO and IEC) standardization organizations.
Clinical Investigation and Standards
The group promotes and develops homogenous interpretation and execution concerning the clinical evaluation and investigation. In this, the MDCG supports other working groups on evaluation issues and clinical investigations. Topics covered in this discussion and coordination include evaluation and post-market clinical follow-up and common specifications in respect of the clinical investigation.
Post-market Surveillance and Vigilance
This discussion group provides support to the MDCG on aspects of post-market surveillance, vigilance, and incident reporting, with the purpose of harmonized and effective implementation of the EU MDR guidance. The topics covered include trend reports and periodic safety update reports, periodic summary reports, field safety notices, field safety corrective actions, development and updating of harmonized reporting forms for incidents, and reviewing of incident reporting practices.
EUDAMED
MDCG facilitates the execution of the EUDAMED database, offering coordination and advice according to the work of other MDCG working groups. The EU Commission must hear out the MDCG before operating or setting up a UDI database, establishing a system that generates unique registration numbers, establishing and managing information on notified bodies and certificates of conformity, and publishing a test report.
New Technologies
MDCG advises on issues related to the application and use of new and emerging technologies in medical science, including apps, software, and cybersecurity. The goal is to identify the latest issues that may arise when using medical devices. Areas covered under this MDCG guidance include electronic instructions on the use of medical devices, development of proposals for guidance and common specifications, and sufficiency of the current regulatory framework in relation to those challenges and technologies.
Borderline and Classification
In this, the MDCG assists with questions relating to the qualification of a medical device, including those products that don’t have an intended medical purpose. The team may look into the matters related to the suitable type of classification for a specific device.
Market Surveillance
The group focuses on administrative measures and enforcement activities in relation to the control and surveillance of medical devices put on the market. Areas covered under this guidance include conformity assessment related to products that don’t need the involvement of notified bodies, general obligations of economic operators, the implementation and application of the performance, and general safety requirements.
Conclusion
The inclusion of MDCG affects the medical device manufacturers, their service providers, and the Notified Bodies. The Medical Device Coordination Group tells when the medical device is ready for use under MDR. Hence, it ensures the safety and effectiveness of the products.
You may go back to our EU MDR guide.
If you are interested in the European market you can contact us for a preliminary discussion. You can also look at our dedicated page for European medical device registration.
