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.
SCENIHR publishes final opinion on nanomaterials in medical devices
19 January 2015
The European Commission Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR), has published its final opinion ‘Guidance on the Determination of Potential Health Effects of Nanomaterials Used in Medical Devices’.
The guidance provides information on how to evaluate the risk when a nanomaterial is used in a medical device. According to the EU Recommendation for the definition of a nanomaterial (Commission Recommendation 2011/696/EU, EC 2011) any particulate substance with at least one dimension in the size range between 1 and 100 nm is considered a nanomaterial. Such nanoparticles exhibit specific characteristics that differ from the characteristics of larger sized particles with the same chemical composition. The guidance highlights the need for special considerations in relation to the safety evaluation of nanomaterials, in view of the possible distinct properties, interactions, and effects that may differ from conventional forms of the same materials.
SCENIHR recommends a four-phase approach based on potential release and characteristics of the nanomaterials, first evaluating the potential of a device to release nanoparticles either directly or due to wear and tear of the device during use. In phase two, it recommends determining the distribution of nanoparticles released and also their "persistence potential". Phase three involves toxicological evaluation and for this it is necessary to use appropriate toxicity tests that take into account the exposure characteristics and potential for persistence in specific organs. The fourth and last phase focuses on final risk characterization.
FDA issues draft guidance on accessory classification
18 January 2015
The US Food and Drug Administration (FDA) has published a draft guidance titled 'Medical Device Accessories: Defining Accessories and Classification Pathway for New Accessory Types: Draft Guidance for Industry and Food and Drug Administration Staff', available from here.
The draft explains that FDA is planning to regulate low risk accessories separately from the parent device, instead of the current policy of regulating them within the same classification, and includes the following definitions:
Accessory: A device that is intended to support, supplement, and/or augment the performance of one or more parent devices. Parent Device: A finished device whose performance is supported, supplemented, and/or augmented by one or more accessories.