Your CRO partner for successful management of clinical studies in Europe, US and Canada for medical devices, IVDs and combination products.
A trusted resource for US and EU medical device regulatory and quality system requirements also providing EU Authorized Representative and US Agent services.
In Vitro Diagnostics
In Vitro Diagnostics
IVDs have distinct requirements in both the US and Europe. We have the IVD regulatory, quality system and clinical study expertise needed for US and European market entry.
Helping companies understand the important differences between US and European requirements for drug-device combination products and drug delivery devices.
Juncker reverses decision on Commission home for devices, medicines and cosmetics
23 October 2014
According to the website of IVD Regulation Rapporteur Peter Liese, the President of the European Commission has reversed his decision to move responsibility for medical devices, medicines and cosmentics from Directorate Geneneral (DG) SANCO to DG ENTR, the industry directorate, following loud protests from many quarters, including Dr Liese and Glenis Willmott, the British MEP who will be Rapporteur for the remaning negotiations on the Medical Devices Regulation.
One of the standards included in the list is ISO 15223-1:2012, 'Medical devices - Symbols to be used with medical device labels, labeling, and information to be supplied - Part 1: General requirements', for which the extent of recogmition has been extended to include all medical devices, rather than just IVDs. However, this inclusion in the recognised standards list appears to be a little premature, because the Final Rule accepting symbols in place of text has not yet been published.
Accordingly, until the Final Rule is published, which will be followed by an FDA guidance document according to the FDA, pre-market submissions must still abide by the current regulaltion that requires all warnings and precautions on device labels to be in English text. Most manufacturers marketing the same device in the US and other international markets, where the symbols on their own are accepted, will need to continue for the time being with the practice of writing an explanation of each symbol used adjacent to the symbol.