Medical instruments and apparatus En

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Synonyme

Medicine--Instruments Medical products Medicine--Equipment and supplies Apparatus, Medical Medical devices Medicine--Apparatus Instruments, Medical Medical apparatus

Discipline

Droit (104) Sociologie (54) Economies et finances (24) Sciences de l'information et de la communication (23) Histoire (12) Science politique (8) Gestion et management (6) Histoire, Philosophie et Sociologie des sciences (4) Psychologie (3) Education (2) Anthropologie sociale et ethnologie (2) Méthodes et statistiques (1) Géographie (1) Démographie (1) Art et histoire de l'art (1) Anthropologie biologique (1)

Type de document

Autres (184) Billets de blog (179) Articles (63) Colloques et conférences (14) Livres et chapitres d'ouvrages (11) Textes imprimés (4) Recensions (4) Rapports (3) Mémoires, Thèses et HDR (2) Prépublication (2) Données d'enquêtes (1) Jeux de données (1)

Auteur

Date

282 documents
EMA – Publication of the Questions and answers on the information session on the pilot for expert panels' advice for orphan medical devices held the 23 September 2024
(11 déc. 2024)
Gradual roll out of EUDAMED - Q&As on practical aspects related to the implementation of Regulation (EU) 2024/1860 (November 2024)
(10 déc. 2024)
MDCG 2023-3 rev.1 - Questions and Answers on vigilance terms and concepts as outlined in the Regulation (EU) 2017/745 under Regulation (EU) 2017/746 - November 2024
(10 déc. 2024)
EU4Health call for tenders: horizon scanning for medical devices & in vitro diagnostic medical devices
(10 déc. 2024)
Study supporting the monitoring of availability of medical devices on the EU market
(10 déc. 2024)
Update - Notified bodies survey on certifications and applications
(10 déc. 2024)
New Zealand Medicines and Medical Devices Safety Authority (Medsafe) Guideline on the Regulation of Therapeutic Products (Catapult’s regulatory round-up – September 2024)
(19 nov. 2024)
New Zealand Medicines and Medical Devices Safety Authority (Medsafe) Considerations for First-In-Human (FIH) and Early Phase Clinical Trials (Catapult’s regulatory round-up – September 2024)
(19 nov. 2024)
New Zealand Medicines and Medical Devices Safety Authority (Medsafe) - Clinical Trial Safety Monitoring and Reporting for Investigational Products (Catapult’s regulatory round-up – September 2024)
(19 nov. 2024)
MDCG 2022-5 rev.1 - Guidance on borderline between medical devices and medicinal products under Regulation (EU) 2017/745 on medical devices - October 2024
(11 nov. 2024)
MDCG 2021-25 rev.1 - Application of MDR requirements to "legacy devices" and to devices placed on the market prior to 26 May 2021 - October 2024
(11 nov. 2024)
MDCG 2024-11 - Guidance on qualification of in vitro diagnostic medical devices (October 2024)
(11 nov. 2024)
MDCG 2024-12 - Guidance and templates for conformity assessment bodies, notified bodies, designating authorities, and joint assessment teams
(11 nov. 2024)
EMA – Tenth Industry Standing Group (ISG) meeting - 26 September 2024: presentation materials of the event are now available
(8 nov. 2024)
EMA - Highlights from the first Expert Panels and Notified Bodies workshop held the 22 April 2024
(8 nov. 2024)
EMA – Publication of the event’s materials of the Small and medium-sized enterprises info day held the 18 October 2024
(8 nov. 2024)
MDCG 2021-4 rev.1 - Application of transitional provisions for certification of class D in vitro diagnostic medical devices under Reg (EU) 2017/746 - September 2024
(5 nov. 2024)
Hands-on Workshop on EU4Health direct grants other than Joint Actions: Expansion of MyHealth@EU and EURLs in vitro diagnostic medical devices
(5 nov. 2024)
EU4Health call for tenders: framework contract in cascade for the implementation of pharmaceutical legislation and data-driven policy for medical products
(5 nov. 2024)
MHRA opens applications from AI developers to join the AI Airlock regulatory sandbox
(5 nov. 2024)
MHRA launches new Strategy for Improving Safety Communications on World Patient Safety Day: Improving information to patients and healthcare professionals
(5 nov. 2024)
Assistive technology: definitions, examples and safe use
(5 nov. 2024)
Department of Health and Social Care - Independent report - Equity in medical devices: independent review - final report
(5 nov. 2024)
MHRA announces two new UK Approved Bodies to certify medical devices (Catapult's regulatory round-up - february 2024)
(5 nov. 2024)
FDA's Select Updates for the Premarket Cybersecurity Guidance: Section 524B of the FD&C Act (Catapult's regulatory round-up - March 2024)
(5 nov. 2024)

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