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.
HPRA holding a Medical Devices Information Day on 23 October 2014
16 October 2014
An information day on medical devices will be hosted by the Irish Health Products Regulatory Agency (HPRA) on 23 October 2014 at the Crowne Plaza Hote, Dublin.
HPRA advises That the focus for the event will include a number of areas of current topical interest including:
Medical device developments at European and international level;
Revision of the European legislation on devices;
Ongoing and planned HPRA initiatives in the context of a changing regulatory environment.
The event will also incorporate parallel sessions on medical devices specifically tailored for particular interest groups, including healthcare professionals and industry stakeholders.
A copy of the agenda for the day can be accessed from here, and registration details from here.
FDA finalises guidance on difference between recalls and enhancements
15 October 2014
The US Food and Drug Administration has issued the final version of its guidance titled 'Distinguishing Medical Device Recalls from Medical Device Enhancements: Guidance for Industry and Food and Drug Administration Staff', available from here.
The guidance explains that the FDA Center for Devices and Radiological Health (CDRH) recognizes that continuous improvement activities, as part of an effective quality system, often have a favorable impact on medical device safety and are part of ongoing efforts to design and manufacture devices that meet the needs of the user and patient. When new iterations of a device involve changes to device design, however, it does not necessarily mean that the existing device should be recalled.
The guidance is intended to:
Clarify when a change to a device constitutes a medical device recall;
Distinguish those instances from device enhancements that do not meet the definition of a medical device recall; and
Clarify reporting requirements under 21 CFR part 806.
Additionally, the guidance seeks to address concerns that device manufacturers may have about making enhancements.
The guidance is organized in a Q&A format, providing responses to questions that FDA believes are helpful in properly distinguishing medical device recalls from medical device enhancements.