MDCG Publishes Updated Guidance on Medical Device Classification (MDCG 2021-24 Rev.1)
In April 2026, the Medical Device Coordination Group (MDCG) published MDCG 2021-24 Rev.1, an updated version of its guidance on the classification of medical devices under Regulation (EU) 2017/745 (MDR).
The document has been endorsed by the MDCG but is not legally binding, and does not represent a formal position of the European Commission.
Key Updates Introduced
The revision includes updates to terminology, structure, and practical guidance across several classification rules.
Terminology Changes
In section 3.1.4 (implantable devices), the word “surgical” has been replaced with “clinical”, and the definition has been updated.
In section 3.2 (application of classification rules), the term “device” has been replaced with “product”.
Updates to Classification Rules and Tables
The following elements have been updated:
Rule 2 – Table
Rule 8 – Table and practical issues (including new notes 1–7)
Rule 9 – Practical issues
Rule 10 – Table and practical issues
Rule 12 – Table
Rule 16 – Table
Rule 22 – Table and practical issues (including a new note)
Additionally:
The structure of Rule 9 (active devices) has been revised to better align with the rule.
General Requirements Section Updated
Section 2.1 (General requirements) has been updated, maintaining that all devices must comply with MDR obligations, regardless of classification.
Role of Classification Under MDR
The guidance reiterates that classification under MDR is risk-based, taking into account factors such as:
Duration of contact
Degree of invasiveness
Local versus systemic effects
Use of energy
Classification determines key regulatory requirements, including:
Conformity assessment procedures (Article 52 MDR)
Clinical evaluation and investigation requirements (Article 61 MDR, Annex XIV)
Post-market surveillance obligations (Articles 83–86 MDR)
Traceability and UDI requirements (Article 29 MDR)
What This Means for Manufacturers
Manufacturers should take note of the updates and consider whether they affect existing documentation.
In particular:
The technical documentation must include the device classification and justification in line with MDR Annex VIII.
Where multiple rules apply, the strictest rule resulting in the highest classification must be used.
Classification continues to be based on the intended purpose defined by the manufacturer.
Manufacturers may wish to review:
Classification justifications
Application of specific rules (e.g. Rules 8, 10, 22)
Alignment with updated guidance and examples
Final Note
While MDCG guidance documents are not legally binding, they are commonly used by notified bodies and competent authorities when assessing compliance with MDR requirements.
Read the full document below.
