We have helped life science companies enter the European and US markets, meet postmarket requirements, and maintain compliance pragmatically and effectively.
GAP ANALYSIS FOR CLINICAL STUDIES
Is your company experiencing problems with your clinical study, such as enrolment issues or significant delays in study start? Our clinical gap analysis will help you understand the problems and implement solutions. Learn more.
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.
FDA issues important new guidance documents and rules
25 April 2015
Over the last few weeks, the US Food and Drug Administration has issued a number of new draft guidance documents and rules that will be of interest to medical device manufacturers.Topics include clinical studies, maket access and post-market data.
Regarding clinical studies, the following documents are now available:
Two amendments have been adopted for the RoHS Directive 2011/65/EU: one concerning substances that are banned from Electrical and Electronic Equipment (EEE) unless an exemption is granted (Annex III and Annex IV); and the other adding two exemptions to the list in Annex IV.
A delegated directive amending Annex II has added four phthalates to the list of banned substances, these being DEHP, BBP, DBP and DIBP. Electrical medical devices placed on the market after 21 July 2014 must not contain the banned substances listed in Annex II of Directive 2011/65/EU unless an exemption has been granted.
The exemptions added to Annex IV are:
Lead as a thermal stabiliser in polyvinyl chloride (PVC) used as base material in amperometric, potentiometric and conductometric electrochemical sensors which are used in in-vitro diagnostic medical devices for the analysis of blood and other body fluids and body gases. Exemption expires on 31 December 2018.
Mercury in electric rotating connectors used in intravascular ultrasound imaging systems capable of high operating frequency (> 50 MHz) modes of operation. Exemption expires on 30 June 2019.