News for Economic Operators: Incident Guideline and Registration Form
As of June 3, 2024, the 'Guidance document Incident Economic Operators' is valid in Switzerland. This is a document that [...]
22 07 2024
22 07 2024
22 07 2024
22 07 2024
MDCG 2021-5 Rev. 1: Updated ‘Guidance on Standardisation for Medical Devices’
On July 2, 2024, the Medical Device Coordination Group (MDCG) published the updated version of the 'Guidance on standardisation for [...]
22 07 2024
22 07 2024
Regulation (EU) 2024/1860: Eudamed Plan Amendments And Legacy IVD Transitional Periods
On July 9, 2024, Regulation (EU) 2024/1860 of the European Parliament and of the Council amending the European Regulation on [...]
18 07 2024
18 07 2024
MDSAP: Requirements for the United States (FDA)
Thanks to the MDSAP (Medical Device Single Audit Programme), it is possible to access multiple markets with a single audit. This [...]
01 07 2024
01 07 2024
Medical Devices: Product and Organisational Quality
When discussing product quality, organisational quality cannot be ignored. In a total approach, quality extends to the entire company system, is [...]
21 06 2024
21 06 2024
MEXICO: First Authorisations of Innovative Software as a Medical Device (SaMD)
COFEPRIS, the Mexican regulatory authority, in May 2024 officially announced the approval of the first software as a SaMDmedical device, [...]
21 06 2024
21 06 2024
EMA: Updated Questions and Answers Guidelines on Devices Used in Combination with Medicines
In May 2024, the European Medicines Agency (EMA), together with the Coordination Group for Mutual Recognition and Decentralised Procedures (CMDh), [...]
21 06 2024
21 06 2024
BRASIL: Reliance Programme Accelerated Access for Medical Devices Already Registered in Other Countries
As of June 3, 2024, it will be possible to place one's high-risk Medical Devices in Brazil, relying on authorisations [...]
27 05 2024
27 05 2024
SWITZERLAND: Marketing and Legacy Devices
Taking a step back in time, it is recalled that Switzerland has been considered a Third Country for Europe since [...]
27 05 2024
27 05 2024
EU: Microplastics Reduction for Medical Devices
With the Regulation (EU) 2023/2055 of 25 September 2023 amending Annex XVII of Regulation (EC) No. 1907/2006, the European Commission [...]
