Technical articles
15/12/2022
How to implement the IEC 60601-1 standard when placing medical electrical equipment on the market
ScopeIEC 60601-1 is the umbrella safety standard for medical electrical (ME) equipment. As its name suggests, ME equipment re
20/10/2022
Changes to medical devices (MDs / IVDMDs)
Once CE marked The life of a medical device is not a long, quiet river… Who has never attended a team meeting on a change t
9/08/2022
Advertising for medical devices (MDs / IVDMDs)
Since 1 January 2013, regulations on advertising have applied not only to pharmaceutical companies, but also to manufacturers of m
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
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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
21/09/2021
Evaluating the biocompatibility of medical devices
Background information Evaluating the biocompatibility of medical devices (MDs) is of major importance as it ensures the safe
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
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,
