6
Jul 22
Telemedicine: When is software a medical device? The Court responds
On February 23, 2012, the Regional Administrative Court of Lombardy—seat of Milan—issued a ruling on the qualification as a medical device of a software platform used to provide healthcare services remotely.
The National Coordination Centre for Ethics Committees published new draft agreements for conducting clinical trials on drugs and medical devices
EU Medical Device Coordination Group (MDCG) approves “Guidance” on the borderline between medical devices and medicinal products in order to support the uniform application of Regulation (EU) 2017/745 (MDR) across the European Union.
19
Apr 22
MDCG Guidance: Notified bodies and surveillance of legacy devices
On February 16, 2022, the Medical Device Coordination Group (MDCG) established by Article 103 of Regulation (EU) 2017/745 (MDR) published a document providing guidance for appropriate surveillance regarding the transitional provisions under Article 120 of the MDR.
19
Apr 22
Import and Distribution of Medical Devices in Switzerland – Amended Rules
The import and distribution of medical devices in Switzerland is governed by the Swiss Therapeutic Products Act and the Swiss Medical Devices Ordinance (MedDO). As of 26 May 2021, MedDO has been revised, foreseeing stricter and additional obligations for the operators active on the Swiss market.
EU Medical Device Coordination Group (MDCG) approves “Guidance” on appropriate surveillance of devices covered by certificates according to the MD Directives, under the transitional provisions of Article 120(3) of the MDR.
