Is CE certificate on Medical Devices valid in Switzerland?
Since Switzerland is a Third Country, there is no CE certificate which is valid in Switzerland, that is to say that [...]
14 12 2021
14 12 2021
14 12 2021
14 12 2021
Which are the transitional periods for the designation of the Swiss Authorised Representative CH REP?
According to Medical Devices Ordinance (MedDO) Article 104a, several transitional periods for the nominee of the Swiss Authorised Representative CH REP [...]
14 12 2021
14 12 2021
Which are the deadlines for UDI affixing?
Deadlines for UDI (Unique Device Identifier) affixing change depending on Medical Devices risk classes. With regards to UDI affixing, Medical Devices [...]
14 12 2021
14 12 2021
How must the CHE REP symbol be used on the device packaging?
The Regulatory Authority Swissmedic provides accurate information on the usage of the Swiss Representative CH REP symbol which is very similar [...]
14 12 2021
14 12 2021
Is CE marking still valid with Swiss – Exit?
While CE certificate is no longer valid, the CE marking placed on the product is still valid. CE marking though does [...]
25 11 2021
25 11 2021
EUROPE: a proposal to extend the IVDR (EU) 2017/746 Regulation
UPDATE OF 25 JANUARY 2022 OFFICIAL PROGRESSIVE ROLL-OUT OF REGULATION IVDR (EU) 2017/746 FOR CERTAIN IVD DEVICES.REGULATION (EU) 2022/112 OF THE EUROPEAN [...]
25 11 2021
25 11 2021
SAUDI ARABIA: UDI deadlines for Medical Devices postponed
Saudi Food and Drug Authority (SFDA) – Regulatory Authority of Medical Devices market in Saudi Arabia – aims to increase patients’ [...]
26 10 2021
26 10 2021
EUDAMED: “UDI/ devices registration” and “Notified Bodies and certificates” modules have been published
At the beginning of October 2021 in the EUDAMED database section of the European Commission website, two new modules have been [...]
26 10 2021
26 10 2021
EUROPE: MDCG 2021-24 on classification Medical Devices has been published
At the beginning of October 2021, Medical Device Coordination Group (MDCG) published the fundamental guideline MDCG 2021-24 “Guidance on classification of [...]
26 10 2021
26 10 2021
AUSTRALIA: TGA updates Medical Devices Essential Principles table
On September, 15th 2021, the Australian Therapeutic Goods Administration (TGA) published on their website the updated table with an essential principles [...]
