Common specifications on Annex XVI products
Draft Commission Implementig Regulation on Annex XVI products published for the feedback procedure until 11 February 2022. Commission Implementing Regulation-AnnexXVI
Harmonised standards published
The Commission implementing decision (EU) 2022/15 has been published. It concers harmonised standards for sterilisation of health care products, aseptic processing of health care products, quality management systems, symbols to be used with information to be supplied by the manufacturer and requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and [...]
Harmonised standards published
The Commission implementing decision (EU) 2022/6 has been published. It concers harmonised standards for biological evaluation of medical devices, sterilisation of health care products, aseptic processing of health care products, quality management systems, symbols to be used with information to be supplied by the manufacturer, processing of health care products and home light therapy equipment [...]
Team-NB Position Paper on MDR/IVDR Implementation
The Position Paper has been approved by a very large majority of voters. Team-NB PositionPaper-on-MDR_IVDR-Implementation V3
Team-NB representative invited to give NBs point of view at the “Forum Risk Management”
Medical Devices made of substances research and innovation opportunities for a sustainable healthProgramma-DispositiviMedici-ENG
NCAs list to perform consultations
Information from HMA on which national competent authorities (NCAs) have the capabilities to perform drug-device combination product consultations. See the link on HMA website: https://www.hma.eu/57.html
Questions and Answers on repackaging & relabelling activities under Article 16 Regulations.
The Questions and Answers has just been published as MDCG 2021-26 document. MDCG_2021_26_Art16
Team-NB Position Paper on “Artificial Intelligence”
During the General Assemble Meeting, Team-NB members approved a new position paper prepared by the “AI&Mobile-Ap-TF” internal task force with the intention to express their opinion and concerns regarding the upcoming regulations. Team-NB-PositionPaper-Artificial-Intelligence
Team-NB Position Paper on “Article 117 – NB Opinion template”
Team-NB members approved a new position paper prepared by the “Article 117” internal task force during the General Assemble Meeting with the intention to provide a template for the opinion of the Notified Body. Team-NB-PositionPaper-Article117-NB-Opinion-Template-V1
MDCG guidance
MDCG 2021-24 Guidance on classification of medical devices has been published. Here is the link https://ec.europa.eu/health/sites/default/files/md_sector/docs/mdcg_2021-24_en.pdf