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 new guidance documents
26 January 2016
Since the beginning of 2016, the US Food and Drug Administration (FDA) has been busy releasing new draft and final guidance documents for medical devices, including the following:
MedTech Europe provides update on MDR/IVDR status for 2016
8 January 2016
In a web announcement dated 7 January 2016, the European medical device/in vitro diagnostics (IVD) industry association MedTech Europe provided a status report on the trilogue discussions on the forthcoming regulations expected to replace the Medical Devices, Active Implantable Devices and IVD Devices Directives within the next five years.
The announcement states: "In December 2015, The Netherlands announced that, under their Presidency of the Council, and during the next political and technical meetings scheduled until March 2016, substantial discussions will revolve around: scrutiny/special NBs, genetic testing, CMR chemicals, reprocessing, liability insurance, transitional measures and the validity of certificates, classification (rules 6, 19 and 21), and clinical investigations."
Considering that the initial plan was for final texts to have been agreed by the beginning of December 2015, there is little optimism that the trilogue negotiations will be completed by March 2016, with the current estimation being, at best, by the time of the formal meeting of the Employment, Social Policy, Health and Consumer Affairs Council (EPSCO) scheduled for 17 June 2016. It is understood that five 'political' trilogue and up to 15 'technical' trilogue meeting have been scheduled during the period of the Dutch Presidency, which finishes on 30 June 2016, but judging by the number of controversial issues yet to be agreed, further delays may still be possible.