What is MDCG ?
The MDCG (Medical Device Coordination Group) guidelines under MDR 2017/745 provide detailed guidance on implementing and complying with the Medical Device Regulation. These documents cover various aspects such as classification, conformity assessment, clinical evaluation, post-market surveillance, and more.
The Medical Device Coordination Group (MDCG) is a body established under Article 103 of the Medical Device Regulation (MDR 2017/745). Its primary role is to provide expert advice and guidance to support the uniform implementation of the MDR and IVDR (In Vitro Diagnostic Regulation) across the European Union. Composed of representatives from EU Member States and chaired by the European Commission, the MDCG aims to harmonize regulatory practices and ensure a high level of health and safety for patients.
Key Roles of the MDCG under MDR 2017/745
- Guidance Development:
MDCG issues guidance documents to clarify and standardize how manufacturers, notified bodies, and other stakeholders implement MDR requirements. These guidelines cover various aspects such as clinical evaluation, post-market surveillance, and conformity assessment.
- Support to Notified Bodies:
Provides recommendations on the designation and monitoring of notified bodies, which assess medical device compliance with MDR.
- Harmonization of Practices:
Facilitates consistent interpretation and application of MDR requirements across Member States to prevent discrepancies in regulation.
- Advisory Role:
Advises the European Commission on regulatory policy and implementation issues.
- Coordination in Crisis Situations:
Plays a role in coordinating actions during public health emergencies, particularly concerning medical devices.
- Importance of MDCG Guidelines:
Clarity for Stakeholders: MDCG documents serve as a practical tool for manufacturers and regulatory bodies to navigate complex MDR requirements.
- Harmonization: Ensures uniformity across the EU, enabling a single market for medical devices.
- Patient Safety: Strengthens oversight mechanisms, contributing to safer medical devices for public health.
What kinds of role they have been published?
The MDCG Guidelines and MEDDEV Guidance Documents both serve as tools to help stakeholders comply with European regulations governing medical devices. However, they differ in their purpose, scope, and regulatory frameworks they support.
Here are Key differences between MDCG guideline and MEDDEV guideline:
| Aspect | MDCG Guidelines | MEDDEV Guidance Documents |
| Regulatory Framework | Supports MDR 2017/745 and IVDR 2017/746 (current regulations). | Supported the previous MDD 93/42/EEC and AIMDD 90/385/EEC. |
| Authority | Issued by the Medical Device Coordination Group (MDCG) under the European Commission, involving experts from all Member States. | Created by the European Commission in consultation with stakeholders, including notified bodies, industry groups, and healthcare professionals. |
| Objective | Aims to harmonize implementation of the MDR/IVDR across Member States and provide clarification on new requirements. | Focused on aiding compliance with the Medical Devices Directives before MDR/IVDR came into force. |
| Applicability | Addresses new requirements introduced by MDR, such as clinical evaluation, UDI (Unique Device Identification), and post-market surveillance. | Focused on legacy requirements, such as Essential Requirements under MDD/AIMDD. |
| Structure | Typically more comprehensive and specific to MDR/IVDR, often addressing newer concepts like software as a medical device (SaMD). | Focused on broad interpretations of MDD/AIMDD requirements, with less emphasis on technical innovations. |
| Current Relevance | Fully relevant and mandatory for compliance with the MDR/IVDR. | Now largely outdated, though useful for understanding legacy device compliance during transitional periods. |
What kinds of role they have been published? and what is the importance
1. MDCG 2019-3: Guidance on Significant Changes under Article 120 MDR
This document clarifies what constitutes a "significant change" for medical devices transitioning from the previous directives (MDD or AIMDD) to MDR compliance.
Explains updates to design or intended purpose that would necessitate compliance with MDR instead of operating under transitional provisions.
Provides examples of significant changes, such as changes to raw materials, sterility, or software updates that impact safety or performance.
Emphasizes that minor administrative changes, such as updates to labels, are not considered significant.
Importance: Helps manufacturers maintain CE marking without prematurely requiring full MDR certification
2. MDCG 2020-6: Clinical Evidence for Legacy Devices
Guidance for manufacturers of legacy devices (those CE-marked under MDD or AIMDD) on how to demonstrate clinical evidence under MDR.
Specifies the clinical evaluation requirements needed to ensure safety and performance under MDR.
Discusses the use of existing clinical data while identifying gaps to be addressed through new studies.
Covers how to demonstrate equivalence with other devices for clinical evaluation purposes.
Importance: Provides a pathway for legacy device manufacturers to remain compliant under the new MDR framework
3. MDCG 2021-24: Guidance on Classification of Medical Devices
Detailed interpretation of the classification rules outlined in Annex VIII of MDR, which categorize devices based on their risk, duration of use, and invasiveness.
Clarifies borderline classifications, such as devices used in combination with pharmaceuticals.
Outlines special rules for active implantable devices, sterilizers, and devices used in a clinical setting.
Includes guidance on accessory devices and their classifications.
Importance: Assists manufacturers in ensuring the correct classification of devices, which is crucial for compliance and conformity assessment
4. MDCG 2021-25: Guidance on Borderline Products
Defines the criteria for distinguishing medical devices from other product categories (e.g., cosmetics, biocides, or pharmaceuticals).
Provides a decision-making flowchart for borderline product identification.
Offers case studies and real-world examples to help classify complex products.
Discusses specific scenarios such as combination products and software used in diagnosis.
Importance: Ensures clarity in the regulatory status of products, reducing ambiguity and compliance risks
5. MDCG 2019-11: Qualification and Classification of Software
Focuses on the qualification of software as a medical device (SaMD) and its classification under MDR.
Explains when software qualifies as a medical device, particularly if it performs functions like diagnosis, monitoring, or prediction.
Provides examples of software use cases and their corresponding classifications.
Discusses unique challenges posed by artificial intelligence (AI) and machine learning in medical software.
Importance: Essential for software developers to align with MDR requirements for digital health innovations
6. MDCG 2019-16: Cybersecurity for Medical Devices
Offers a comprehensive guide on integrating cybersecurity measures throughout the lifecycle of medical devices.
Discusses threats and vulnerabilities that could compromise device safety or performance.
Recommends risk assessment strategies, secure software development practices, and post-market surveillance for cybersecurity.
Provides examples of cybersecurity incidents and mitigation strategies.
Importance: Addresses the growing importance of cybersecurity in safeguarding patient data and device functionality
7. MDCG 2023-3: Incident Reporting under MDR
Clarifies how manufacturers should report serious incidents and trends involving medical devices.
Defines the criteria for a "serious incident," including device malfunctions or adverse effects that pose risks to patient health.
Describes the timeline for reporting incidents and the format for incident notifications.
Highlights common reporting errors and how to avoid them.
Importance: Ensures a robust post-market surveillance system, allowing regulators to address safety concerns promptly