Webinar ‘Measures to comply with new EU Reg. 2022/2480 amending EU Reg. 1025/2012’
This webinar intends to explain what measures CEN and CENELEC have put in place in order to timely respond to the new provisions of the EU Reg. 2022/2480 amending EU Reg. 1025/2012, published on 19 December 2022 in the OJEU. The new regulation shall be applied as of 9 July 2023. [...]
Webinar 'The functioning of the HAS system, interactions with HAS consultants and best practices'
This webinar will aim to provide first-hand information to CEN and CENELEC Technical Committees on the functioning and state-of-play of the HAS system, and best practices to ensure smooth cooperation between the different actors/stakeholders. During this session, CEN and CENELEC, together with Ernst & Young (EY) will provide guidance to Technical Committees on how to interact with HAS consultants, clarify the role of HAS consultants and provide hands-on information on the use of the EY tools developed for this purpose. [...]
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. [...]
Training for newly appointed CEN & CENELEC Technical Body Officers
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. [...]
Training: CENELEC Submission Interface - submission of documents from TCs
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.
Training: CENELEC Submission Interface - submission of documents from TCs
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 [...]