M/320 - Breast implants
Standardization mandate to CEN concerning the development of European standards relating to medical devices (subject: breast implants)
Mandate M/320 directs CEN to develop European standards relating to breast implants as medical devices. The mandate aims to establish harmonized technical specifications and requirements to ensure the safety, quality, and performance of breast implants within the EU market. This standardization effort supports regulatory compliance and enhances patient protection. The mandate reflects the European Commission's commitment to improving medical device standards through collaboration with the European Standards Organization (CEN). The resolution reference for this mandate is CEN/BT C95/2002.
Purpose
The mandate M/320 concerns the development of European standards specifically related to breast implants. It tasks CEN (European Committee for Standardization) with establishing harmonized standards to support the regulatory framework and ensure the safety, quality, and performance of breast implant medical devices within the EU.
Standardisation request
CEN is requested to develop European standards that address various aspects of breast implant medical devices. These may include design, manufacturing, testing, performance requirements, and safety criteria that breast implants must meet to comply with relevant EU medical device directives and regulations.
Expected deliverables
The expected deliverables comprise a suite of harmonized European standards concerning breast implants. These standards will provide clear technical specifications and assessment methods to be used by manufacturers, regulatory authorities, and notified bodies. The standards are intended to facilitate conformity assessment and market surveillance activities, ultimately ensuring patient safety.
Context
This mandate was issued under the framework of aligning medical device regulations across the European Union and improving product safety. Breast implants are a significant class of implantable medical devices requiring specific regulatory attention due to their use in surgical procedures and impact on patient health. The standardisation process supports the effective implementation of EU medical device directives and regulations by providing technical guidance to stakeholders.
The mandate reference M/320 was discussed and approved through the CEN/BT resolution C95/2002.
This mandate covers the development of European standards related to medical devices specifically focusing on breast implants.
General Information
ISO 14607:2018 specifies particular requirements for mammary implants.
With regard to safety, this document specifies requirements for intended performance, design attributes, materials, design evaluation, manufacturing, packaging, sterilization, and information supplied by the manufacturer.
- Standard55 pagesEnglish languagee-Library read for1 day
ISO 14607:2007 specifies particular requirements for mammary implants for clinical practice.
With regard to safety, ISO 14607:2007 specifies requirements for intended performance, design attributes, materials, design evaluation, manufacturing, sterilization, packaging and information supplied by the manufacturer.
- Standard37 pagesEnglish languagee-Library read for1 day
ISO 14607:2018 specifies particular requirements for mammary implants.
With regard to safety, this document specifies requirements for intended performance, design attributes, materials, design evaluation, manufacturing, packaging, sterilization, and information supplied by the manufacturer.
- Standard55 pagesEnglish languagee-Library read for1 day
ISO 14607:2007 specifies particular requirements for mammary implants for clinical practice.
With regard to safety, ISO 14607:2007 specifies requirements for intended performance, design attributes, materials, design evaluation, manufacturing, sterilization, packaging and information supplied by the manufacturer.
- Standard37 pagesEnglish languagee-Library read for1 day
This International Standard specifies particular requirements for mammary implants for clinical practice. With regard to safety, this International Standard specifies requirements for intended performance, design attributes, materials, design evaluation, manufacturing, sterilization, packaging and information supplied by the manufacturer.
- Standard36 pagesEnglish languagee-Library read for1 day
BT noted that this work in TC285 level depends on new funding by the European Commission. See document BT C 95/2002 (BT N6734) ++ Registered under VA/CEN lead further to info from ISO/CS (NT/030520).
- Standard36 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/320 is a European Standardization Mandate titled "Standardization mandate to CEN concerning the development of European standards relating to medical devices (subject: breast implants)". Standardization mandate to CEN concerning the development of European standards relating to medical devices (subject: breast implants) There are 6 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.