We have helped life science companies enter the European and US markets, meet postmarket requirements, and maintain compliance pragmatically and effectively.
Your CRO partner for successful management of clinical studies in Europe, US, Canada and Israel 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.
Germany updates its law on medical device installation, operation, use and maintenance (MPBetrV)
3 September 2014
With a view to the future medical device regulation, the German law on the installation, operation, use and maintenance of medical devices (Medizinprodukte-Betreiberverordnung, or MPBetrV), has been amended to revise the sections dealing with implants and the reprocessing of devices.
The updated law, available from here (German only), which applies to healthcare providers rather than to manufacturers, expands requirements for implanted devices from just active implants to non-active implants, presumably as a reaction to the PIP breast implant scandal, and tightens the requirements for maintenance. In doing so, a separate article has been created for device reprocessing, which was previously covered within the 'Maintenance' section.
Regarding maintenance and reprocessing requirements, healthcare establishments must ensure that maintenance or reprocessing operations are carried out only by persons with the necessary expertise and facilities for "proper execution of the tasks".
In addition, for the reprocessing of 'critical' devices, the reprocessor must have a quality system certificated by a authorised body.
For implants, a new Annex 3 includes a list of non-active implants for which new requirements are listed, including the provision of implant cards for patients.
The above new provisions will apply from 1 October 2015.
FDA issues final guidance on sex-specific data in clinical studies
21 August 2014
The US Food and Drug Administration (FDA) has posted a final guidance document, “Evaluation of Sex-Specific Data in Medical Device Clinical Studies” outlining specific recommendations for considering sex and other variables during the design stage of a clinical study, to improve consistency of analysis and reporting of information on demographics in labeling and other public documents.
The agency comments that certain medical products may elicit different responses in women than men and these variables may affect the safe and effective use of the device. FDA will hold a webinar on 25 August 2014 at 15:00 Eastern Time to explain the guidance and to provide an opportunity to ask questions.