2023年5月8日 · Team Notified Body (NB) released a confirmation letter that can be used to show: The manufacturer has lodged a formal application, and has a signed agreement in place, with the Notified Body. The template is available on Team NB’s website: HERE. It is also available on the EU Commission’s website: HERE.

2021年7月19日 · Mandatory Declassification Review (MDR) is a means by which any individual or entity can request any Federal agency to review classified information for declassification, regardless of its age or origin, subject to certain limitations.

2024年8月27日 · 随着欧盟医疗器械法规 (MDR)的全面实施，"Letter of Confirmation"（确认函）成为了确保医疗器械在过渡期内合法销售的关键。 角宿Cabebe老师旨在为非专业小白提供易于理解的指导，帮助您了解如何申请Letter of Confirmation，并展示角宿团队如何利用其专业经验，轻松 ...

Manufacturer’s Declaration on MDR Transition Status In relation to Regulation (EU) 2023/607 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices, in particular with respect to

Manufacturers holding Directives Certificates that have been issued from 25 May 2017, and that were still valid on 26 May 2021 and that have expired before 20 March 2023 (date of publication of Regulation (EU) 2023/607) are allowed to continue placing on the market legacy devices until 26 May 2024 if a derogation/exemption has been granted by a ...

2023年4月18日 · Comprehensive guide to EU MDR transition period extension per Regulation 2023/607. Included: timeline of key dates, FAQs, & Before vs After table of the changes.

2024年5月24日 · You can find the classification rule applicable to your medical device set out in Annexes VIII of the MDR. For example: software intended to provide information used to take decisions with diagnosis or therapeutic purposes and software intended to monitor physiological processes is classified as class IIa according to rule 11 of the Annex.

2023年5月26日 · European Commissioners have issued a new confirmation letter regarding recent amendments to the Medical Devices Regulation (MDR). Medical device manufacturers have anticipated the publication of “ Template for NB - Confirmation letter in the framework of Regulation (EU) 2023/607 ”, and industry as well as healthcare providers are anxiously ...

This letter confirms that, Intertek Medical Notified Body AB, a Notified Body (NB) designated against Regulation (EU) 2017/745 (MDR) and identified by the number 2862 on NANDO, has received a formal application in accordance with Section 4.3, first subparagraph of Annex VII of MDR and has signed a written agreement in accordance with Section 4. ...

On 3 July 2023, the Medicines and Healthcare products Regulatory Agency (MHRA) published on its official website the EU MDR Article 120 extension confirmation, a template of the letter to be submitted by Manufacturers to align with Article 120 of the MDR Regulation (EU) 2017/745.