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Bristows | European Union, United Kingdom | 24 May 2023
UK MDR amending legislation heralds arrival of new medical device framework
Following a short debate in the Delegated Legislation Committee on 22 May 2023, the House of Commons unanimously approved the draft Medical Devices…
Burges Salmon LLP | United Kingdom | 22 May 2023
MHRA publishes new adverse incidents guidance for Software as a Medical Device
The MHRA has published new guidance (May 2023) on reporting adverse incidents involving Software as a Medical Device. The advice for manufacturers…
Bird & Bird LLP | United Kingdom | 19 May 2023
AI as a Medical Device
To add to all the chatter about AI, let's talk about AI as a medical device. Last month, the Medicines & Healthcare products Regulatory Agency…
Wardyński & Partners | Poland | 11 May 2023
Advertising of medical devices: Currently only with warnings
On 13 May 2023, a new regulation with detailed requirements for advertising of medical devices enters into force. Advertisers of such products…
Baker McKenzie | USA | 10 May 2023
FDA issues guidance on predetermined change control plans for AI/ML-enabled device software functions
The Food and Drug Administration (FDA) recently issued draft guidance for manufacturers whose medical devices use machine learning (ML) technologies to improve patient care. Through the draft guidance, the FDA intends to provide a least burdensome approach to support iterative improvements to ML-enabled device software functions through modifications, while continuing to provide a reasonable......
Moroğlu Arseven | Turkey | 9 May 2023
Turkish Medicines and Medical Devices Agency published a Guideline on Co-marketed Medicinal Products for Human Use.
Regulation on Licensing of Medicinal Products for Human Use (the "Regulation") has been published in the Official Gazette number 31686 and dated 11…
Moroğlu Arseven | Turkey | 9 May 2023
Turkish Pharmaceuticals and Medical Devices Agency updated the Guidelines for the Classification of Diversification Applications and Variation Applications
Turkish Pharmaceuticals and Medical Devices Agency ("TITCK")'s Guidelines for the Classification of Diversification Applications and Variation…
Moroğlu Arseven | Turkey | 9 May 2023
Türkiye İlaç ve Tıbbi Cihaz Kurumu Ortak Pazarlanan Beşeri Tıbbi Ürünlere İlişkin Kılavuz Yayınladı.
Beşerî tıbbi ürünlerin güvenlik ve kalitesinin sağlanması, ruhsatlandırma işlemlerinde uygulanacak usul ve esasların belirlenmesi ve ruhsatlandırılmış…
Crowell & Moring LLP | USA | 9 May 2023
Is Medical Device Software a “Product”?
Many medical device companies are accustomed to defending product liability litigation, and the applicability of product liability law to traditional…
Moroğlu Arseven | Turkey | 9 May 2023
Withdrawal and Recall Guideline of Medical Devices and In Vitro Diagnostic Devices has been Published
The purpose of the Guideline is to determine the procedures and principles regarding the withdrawal and recall of medical devices and in vitro…
