UK: from the CE mark to the UKCA mark. What to do?
In just over a year, it will be definitively mandatory to affix the UKCA mark on Medical Devices and IVDs [...]
How to market Medical Devices in Switzerland?
As is now widely known, as of 26th May 2021, Switzerland became a Third Country for the EU, following Medical [...]
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 [...]
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 [...]
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 [...]
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 [...]
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While CE certificate is no longer valid, the CE marking placed on the product is still valid.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 [...]
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 [...]
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 [...]
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 [...]
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 [...]
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 [...]
UK: postponed the mandatory UKCA marking. What happens now with Medical Devices and IVDs?
On August 24th ,2021, the UK government decided that mandatory UK Conformity Assessed (UKCA) marking would be delayed to January [...]
USA: FDA has increased fees for 2022 fiscal year by 2.5%
The US Food and Drug Administration (FDA) has published the fee rates corresponding to fiscal year 2022 (FY2022) starting October [...]
BRAZIL: ANVISA, kicks off to UDI system for Medical Devices
At the end of June 2021, the Brazilian Agência Nacional de Vigilância Sanitária (ANVISA) presented new details on the next [...]
EU: first MDR and IVDR harmonised standards published
In July 2021, the first MDR and IVDR harmonised standards were published in the Official Journal of the European Union. [...]
STANDARD: ISO 20916 regulates clinical performance studies for IVD Devices
The ISO 20916:2019 standard “In vitro diagnostic Medical Devices – Clinical performance studies using specimens from human subjects – Good [...]
MEXICO: amendments to the Medical Devices Regulation from 1 June 2021
Since the 1st of June 2021 amendments to the Health Supplies Regulation (Reglamento de Insumos para la Salud RIS, which [...]
