Events & Trainings
This webinar will provide participants with the latest developments regarding the preparation of harmonized standards (hENs) for Healthcare.
It will also provide guidance and solutions to Technical Bodies in the preparation of harmonized standards in support of the Medical Device Regulation (MDR) and the In Vitro Diagnostic Medical Devices Regulation (IVDR) to ensure a smooth citation of healthcare standards in the Official Journal of the European Union. [...]
On Monday 12 December 2022, CEN and CENELEC organised the training for newly appointed CEN and CENELEC Technical Body Officers. This training session is addressed to CEN and CENELEC Technical Body Officers that have entered their function as Chairperson or Secretary since December of the previous year. [...]
On 28 November 2022, CCMC will make available the “Submission Interface” for the submission of standardization documents by technical body Secretaries to CCMC. The aim of the training is to: [...]
The new HAS contract has been signed and the HAS assessment system has re-started in October. The aim of the webinar is to:
• Do a recap of the tasks and responsibilities of the HAS contractor and consultants, as well as the existing processes and flows, and
• Present the novelties of the HAS assessment system.
Target audience: CEN and CENELEC Technical Body Officers, experts involved in the development of harmonized standards.
On 28 November 2022, CCMC will make available the “Submission Interface” for the submission of standardization documents by technical body Secretaries to CCMC. The aim of the training is to: [...]
This webinar discusses specific drafting issues which have shown to potentially lead to lack of compliance HAS assessments.
The webinar focuses on:
• specific drafting rules laid down in the 'CEN-CENELEC Internal Regulations - Part 3' (IR3)
• the formulation of verifiable and unambiguous requirements
• normative references [...]
The objective of this webinar is to give an overview of the overall migration plan but also to give a particular focus on the migration of the platforms that will have a more substantial impact for the CEN members (eg: PROJEXDATA, eTRans).
Target audience: CEN members. [...]
This webinar will provide participants with practical information regarding the preparation of CEN & CENELEC harmonized standards to be cited in the Official Journal of the European Union (OJEU) under the Machinery Directive. It will include: [...]
This webinar will guide you through a comprehensive presentation of the updates in the new 2022 edition of the Internal Regulations Part 3 and will provide specific information on:
- the main changes with regards to the drafting of a Technical Report,
- key elements to be considered in the drafting of documents,
- and an overview of the updated Simple Templates. [...]