A leading European CRO, Regulatory & Quality System consultancy for medical devices, IVDs and drug-device combination products operating in the EU and US.
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.
2019 FDA User Fees announced
22 August 2018
The US Food and Drug Administration (FDA) has announced small increases in user fees for fiscal year 2019, with the new fees, coming into effect on 1 October 2018, being:
* Note:all types of 510(k)s (Traditional, Abbreviated, and Special) are subject to the user fee. However, there is no user fee for 510(k)s submitted to the FDA on behalf of an FDA-accredited third-party reviewer.
** For small businesses with an approved SBD.
Small businesses with an approved SBD with gross receipts or sales of $30 million or less are eligible to have the fee waived on their first PMA, PDP, PMR, or BLA.
Commission issues 'Fact Sheets' on MDR and IVDR Transitions
25 July 2018
The European Commission (EC) has issued two 'Fact Sheets' to assist manufacturers in the transition from the Medical Devices and Active Implantable Medical Devices Directives (MDD and AIMDD) to the Medical Devices Regulation, and also from the In Vitro Diagnostics Directive (IVDD) to the In Vitro Diagnostics Regulation (IVDR).
The Fact Sheet for the MDR explains that during the transitional period, the MDR will come into force gradually, starting with the provisions related to the designation of Notified Bodies and the ability of manufacturers to apply for new certificates under the MDR, and that the transitional period will end on 26 May 2020, the “Date of Application” (DoA) of the Regulation. A similar explanation is included in the Fact Sheet for the IVDR.
The remainder of the documents explain the major changes and consequencies of the new legal requirements, as well as details of what is and what is not allowed during the transition periods leading up to full implementation and beyond.
At the same time, the EC has issued 'Implementation Models' for the MDR and IVDR, providing a step-by-step guide to how manufacturers should manage the transition from the Directives to the Regulations.
One further document was published on the EC website at the same time, this being an exhaustive list of manufacturer's obligations under the MDR, developed by the UK Medicines and Healthcare products Regulatory Agency (MHRA).