Technical articles
7/07/2022
DMDIV: Gradual implementation of regulation (EU) 2017/746
Since 26 May 2002, the placing on the European market of all IVDMDs has been subject to compliance with Regulation (EU) 2017/746 &
7/07/2022
MD marketing in the USA: what are the steps of the 510(k) submission procedure?
Why market a medical device in the United States?The USA is currently the largest medical device market, accounting for 45% of the
20/11/2021
BREXIT: Market access to Great Britain and Northern Ireland
Access to the European and UK markets for health products has changed dramatically since the UK left the European Union on 31 Janu
29/09/2021
UDI : Keys dates
One of the new features of Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR) is the implementation of the UDI sys
19/07/2021
No mutual recognition agreement between the European Commission and Switzerland, what are the impacts for manufacturers?
One of the keys to facilitating bilateral trade between the EU and Switzerland is the Mutual Recognition Agreement (MRA). This agr
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25/05/2021
The implant card, a new requirement for implantable MDs: are you ready?
Article 18 of Regulation (EU) 2017/745 (MDR) sets out the information to be supplied to the patient with an implanted device and i
12/11/2020
More stringent regulations for non-medical products
Cosmetic contact lenses, liposuction devices, wrinkle fillers, tanning booths, lasers, and equipment for tattoo removal and hair r
21/07/2020
Medical devices: management of hazardous substances during the transition to regulation (EU) 2017/745
Protecting human health and the environment from the risks that chemicals can pose has always been a priority for Europe. In 2007,
25/06/2020
What is the scope of IEC62304?
With changes in new technologies and the need to digitise our environments, more and more medical devices (MDs) are integrating or
17/05/2020
Hospital Information Systems (HIS): context, challenges, and opportunities in healthcare data
Healthcare institutions generate and store a vast amount of data. From the moment a patient enters a facility, they provide a sign
28/04/2020
Masks: how to access the french market
Gaining access to the European market depends on the type of mask you wish to market. Below we set out the various types of masks,
