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UK – Medical devices: information for users and patients

What is a medical device? A medical device is a healthcare product or piece of equipment that a person uses for a medical purpose. It...
New UK conformity mark to replace the CE mark in a "no-deal" scenario

UK – New UK conformity mark to replace the CE mark in a « no-deal »...

The UK Government has unveiled the design for a new UK conformity mark that would replace the CE mark in the UK in the event that...
Another Reason to Update Your Biocompatibility Approach: EU MDRs

Europe – Another Reason to Update Your Biocompatibility Approach: EU MDRs

Medtech companies have been working for a couple years to update their approach to biocompatibility testing in preparation for the new ISO 10993-1, “Biological evaluation...
Spotlight on Brexit: BSI encouraging manufacturers to apply for certification transfer

Europe – Spotlight on Brexit: BSI encouraging manufacturers to apply for certification transfer

Cliff Edge Brexit remains a likely scenario. It may take weeks (or longer) before there will be certainty about a Brexit outcome. BSI...
US, EU Pledge to Cooperate on UDI Specifications

Europe – US, EU Pledge to Cooperate on UDI Specifications

The US and EU will cooperate to ensure alignment of electronic database specifications for Unique Device Identifiers (UDIs) and will develop a bilateral test...
Survey Highlights Looming Shortfall of IVDR-designated Notified Bodies

Europe – Survey Highlights Looming Shortfall of IVDR-designated Notified Bodies

Nearly half (46%) of surveyed notified bodies (NBs) recently indicated that they do not intend to apply for designation under the European in vitro diagnostic regulation...
UK Drafts Contingency Legislation for Drug and Device Regulations Under No-deal Brexit

UK – UK Drafts Contingency Legislation for Drug and Device Regulations Under No-deal Brexit

The UK government has published three pieces of draft legislation, covering the regulation of medicines, medical devices and clinical trials, as part of its...
Survey on NBs applications against IVD new regulation

Europe – Survey on NBs applications against IVD new regulation

Following interest from the sector concerning the designation process in the framework of the IVDR regulation and as an act of transparency, you will find...
Are Wearables Medical Devices Requiring a CE-Mark in the EU?

Europe – Are Wearables Medical Devices Requiring a CE-Mark in the EU?

Wearable watches that help consumers obtain a better understanding of their eating patterns; wearable clothes that send signals to treating physicians; smart watches: they...
EU Lists First Notified Body Under MDR

Europe – EU Lists First Notified Body Under MDR

BSI United Kingdom (UK) became the first notified body (NB) to be officially designated as an NB under the Europe Union’s (EU) medical device...

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