Mdr.guide

MDCG 2021-21 Rev.1 Performance Eval of SARS-CoV-2 IVDs

WebThe European Commision has published Revision 1 of “MDCG 2021-21 : Guidance on performance evaluation of SARS-CoV-2 in vitro diagnostic medical devices".

Actived: 2 days ago

URL: https://www.mdr.guide/regulatory-blog/mdcg-2021-21-rev1-performance-eval-of-sars-cov-2-ivds-

MDCG 2021-11 – Guidance on Implant Card “Device Types”

WebMDCG 2021-11 – Guidance on Implant Card “Device Types” . 20 Jul. Written By MDRG. The #MDCG has released a document regarding the information provided …

Category: Health Go Health

MDCG 2021-24 : Guidance on Classification of Medical Devices

WebMDCG 2021-25 : Application of MDR requirements to ‘legacy devices’ & devices placed on the market prior to 26 May 2021 (In accordance with Directives …

Category: Health Go Health

MDCG 2021-27 – Q&A on Articles 13 & 14 of MDR/IVDR ️

WebThe Medical Device Coordination Group #MDCG has released the MDCG 2021-27 Questions and Answers on Articles 13 & 14 of Regulation (EU) 2017/745 and …

Category: Medical Go Health

MDCG 2021-20 : Instructions for generating CIV-ID for MDR …

WebThe #MDCG has released a new guidance regarding clinical investigations under #MDR it is clarified how Competent Authorities should use EUDAMED in obtaining …

Category: Health Go Health

Implantable Medical Devices Factsheet — Medical Device …

WebThe #EC has released a factsheet for manufacturers of implantable medical devices and related to the application of Article 18 of Regulation (EU) 2017/745. Key …

Category: Medical Go Health

List of Meetings of the MDCG & Sub-groups

WebAn updated list of the planned meetings for the Medical Device Coordinator Group #MDCG and the various subgroups for 2022 has been published. Read it to …

Category: Medical Go Health

EUDAMED Registration Q&A

WebMDCG 2021-13 - EUDAMED Registration Q&A 📢. 29 Jun. Written By MDRG. The #MDCG has just released a Q&A on the rules and obligations for registration in …

Category: Health Go Health

Clarifying "Significant Change" in Medical Devices: Health …

Web· Objective: Enhance understanding of "significant change" in Medical Devices Regulations, aiding manufacturers of Class III or IV devices in Canada.

Category: Medical Go Health

MDCG 2021-9: Positon Paper on UDI Implementation for Contact …

WebThe MDCG has published a new position paper on UDI requirements implementation for (i) contact lenses, (ii) spectacle frames, (iii) spectacle lenses and (iv) …

Category: Health Go Health

Published Overview of Ongoing guidance development and …

WebSee link below   🔗 Original Document:  https://health.ec.europa.eu/system/files/2023-03/mdcg_ongoing-guidance.pdf

Category: Health Go Health

Medical Device Single Audit Program Quick Guide Medical …

WebIn addition to the members above, the European Union (EU) and World Health Organization (WHO) are MDSAP Official Observers.The new MDSAP Affiliate Members are …

Category: Health Go Health

Application of Article 97 MDR to legacy devices ⚡

WebA new addition to the EU MDCG guidance 2022-18 has been published, addressing the implementation of Article 97 of the MDR for legacy devices that have …

Category: Health Go Health

MDCG 2020-3 rev.01: Key Takeaways — Medical Device …

WebShop. MDCG 2020-3 rev.01: Key Takeaways. 23 May. Written By MDRG. 🔹 This guidance addresses significant changes for devices under the transitional provision …

Category: Health Go Health

MDCG 2018-1 Update on UDI-DI

Web15 May. Written By MDRG. The MDCG has updated the MDCG 2018-1 Rev.4 “Guidance on BASIC UDI-DI and changes to UDI-DI” document with some minor updates. The main …

Category: Health Go Health

EU 2021/2282 Regulation on Health Technology Assessment

WebThe EU has released the Regulations (EU) 2021/2282 “oon health technology assessment an amending Directive 2011/24/EU. With relation to MDR/IVDR, …

Category: Health Go Health

MDCG 2019-6 Rev 3

WebThe #MDCG has updated a document from 2019 regarding Q&A for requirements relating to Notified Bodies. The primary change regards a question on “May …

Category: Health Go Health