M/321 - Sub-categories for medical dev
Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices (Subject: sub-categories for medical devices)
Mandate M/321 requests CEN and CENELEC to develop European standards specifically addressing sub-categories of medical devices. The mandate aims to establish clear and consistent standardization to support regulatory compliance, safety, and performance of various medical device types. This initiative facilitates harmonization across member states, enhancing market access and patient safety. The mandate was subject to approval or disapproval as referenced in the CEN Board of Technical Bodies resolution C20/2003.
Purpose
The mandate M/321 aims to develop European standards specifically related to medical devices. It focuses on establishing sub-categories within the broader category of medical devices to support more precise standardisation.
Standardisation request
The request directs CEN (European Committee for Standardization) and CENELEC (European Committee for Electrotechnical Standardization) to create and develop standards that define and regulate sub-categories of medical devices. This will involve identifying distinct classes or groups within medical devices to facilitate clearer regulatory and technical frameworks.
Expected deliverables
- A set of European standards detailing sub-categories for medical devices.
- Guidance and classification criteria for differentiating medical device types.
- Technical specifications to support harmonised compliance and safety requirements within these sub-categories.
Context
This mandate was approved or disapproved through a resolution referenced as CEN/BT C20/2003. The development of sub-categories is intended to clarify and improve regulatory and standardisation processes for medical devices across Europe, supporting the Medical Devices Directive and enhancing safety, interoperability, and market surveillance.
The mandate covers the development of European standards related to the classification of sub-categories for medical devices. It focuses on standardisation work concerning various types and categories of medical devices within the healthcare sector to ensure consistent and harmonised classification across the European Union.
General Information
This Technical Report lists collective terms and codes for groups of medical devices having common features. The listing is structured so that the terms can be used for the purposes required in regulatory reporting and for communication relevant to the application of the medical device regulation.
For certain purposes in the application of the Medical Devices Directives, there is an urgent need for the development of a list of collective terms based on the identified principles to be used, for examples, as follows:
- to illustrate the scope of certificates issued by Notified Bodies when assessing which groups, families or types of medical devices are covered within a manufacturer's quality system,
- to be used to identify the range of skills and general technological abilities for which a Notified Body has been approved, and is so appointed by the relevant Competent Authority,
- for the exchanges of information between Competent Authorities when general information on individual manufacturers capabilities is notified for inclusion in the European Database for Medical Devices (EUDAMED).
For the purpose of developing sets of collective terms, Accessories to medical devices are integrated de facto in the corresponding medical device collective term.
- Technical report15 pagesEnglish languagee-Library read for1 day
This Technical Report lists collective terms and codes for groups of medical devices having common features. The listing is structured so that the terms can be used for the purposes required in regulatory reporting and for communication relevant to the application of the medical device regulation.
For certain purposes in the application of the Medical Devices Directives, there is an urgent need for the development of a list of collective terms based on the identified principles to be used, for examples, as follows:
- to illustrate the scope of certificates issued by Notified Bodies when assessing which groups, families or types of medical devices are covered within a manufacturer's quality system,
- to be used to identify the range of skills and general technological abilities for which a Notified Body has been approved, and is so appointed by the relevant Competent Authority,
- for the exchanges of information between Competent Authorities when general information on individual manufacturers capabilities is notified for inclusion in the European Database for Medical Devices (EUDAMED).
For the purpose of developing sets of collective terms, Accessories to medical devices are integrated de facto in the corresponding medical device collective term.
- Technical report15 pagesEnglish languagee-Library read for1 day
Frequently Asked Questions
A European Standardization Mandate is a formal request from the European Commission to the European Standardization Organizations (CEN, CENELEC, and ETSI) to develop European standards (ENs) in support of EU legislation and policies. Mandates are issued under Regulation (EU) No 1025/2012 and help ensure that products and services meet the essential requirements set out in EU directives and regulations.
M/321 is a European Standardization Mandate titled "Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices (Subject: sub-categories for medical devices)". Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices (Subject: sub-categories for medical devices) There are 2 standards developed under this mandate.
Standards developed in response to a mandate and cited in the Official Journal of the European Union become "harmonized standards". Products manufactured in compliance with harmonized standards benefit from a presumption of conformity with the essential requirements of the corresponding EU directive or regulation, facilitating CE marking and market access across the European Economic Area.