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GAP ANALYSIS FOR CLINICAL STUDIES
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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.
Device Regulation trilogue meetings scheduled to be completed by year-end
2 October 2015
At the ABHI Regulatory Conference held in London on Wednesday 30 September 2015, John Wilkinson, the Director of Devices at the UK Competent Authority (CA), the Medicines and Healthcare products Regulatory Agency (MHRA), reported that dates were now set for five trilogue meeting to take place between October and December 2015.
With the draft texts from the Council for the new Medical Devices and In Vitro Diagnostic Device (IVD) Regulations now being finalised by the Permanent Representatives Committee on 23 September 2015, the way is now clear for trilogue discussions to take place. Following the expected endorsement of the Council's positions by the Employment, Social Policy, Health and Consumer Affairs (EPSCO) Council on 5 October 2015, the first trilogue meeting between the Council, Commission and Parliament representatives has been scheduled for 13 October, with a further meeting on 26 or 29 October, two meetings in November, on the 10th and 18th, and one on 3 December.
While it has taken seven years to reach this point, and significant differences still exist between the positions of the three parties, delegates are apparently confident that consensus can be achieved on both Regulations within the timescale set. This is no doubt because of a significant amount of behind the scenes consultation and discussion on the remaining controversial points with other stakeholders.
Other speakers at the conference identified a number of residual anomalies within the texts that need to be corrected within the trilogue discussions, otherwise confusion in certain areas will remain, and in others, simple devices may end up with over-burdensome regulatory requirements that are unwarranted by their risk profile.
If the trilogue discussions run to plan, a second Parliament reading of the agreed texts will take place during the first quarter of 2016, with adoption before the end of the second quarter. The transition periods are expected to be three years for medical devices and five years for IVDs. Concern was expressed at the conference, however, that three years may be insufficient for medical devices, as no 'grandfathering' will be allowed, meaning that every device now on the European market must be reassessed against the new requirements, giving not only manufacturers a significant regulatory challenge, but also Notified Bodies and Competent Authorities alike. In addition, the European Commission itself, with only eight staff members working in the devices sector, will have its work cut out to draft some 56 implementing acts, required to ensure full understanding and operation of the Medical Devices Regulation alone - that's nearly two per month over a three-year transition period.
Finally, the European Database (EUDAMED) must be revised and updated to cope with all the new data sets that the draft regulations now require, including different access levels for CAs, Notified Bodies (NBs), economic operators, healthcare professionals and patients. The Commission's record on the development of EUDAMED has so far not been ideal, so this upgrade to EUDAMED III is considered a significant challenge, especially as the regulations state that once adopted, manufacturers are able to elect to use the new provisions immediately, rather than the superseded directives. So there are plenty of opportunities for delay to some aspects of system operational functionality that are likely to cause significant confusion over the coming months and years.
MHRA publishes guidance on use of DEHP in medical devices
18 September 2015
The UK Competent Authority (CA) for medical devices, the Medicines and Healthcare products Regulatory Agency (MHRA) has published revised guidance on the use of DEHP to soften plastics used in many medical devices, following the report from the EU Scientific Committee on Emerging and Newly-Identified Health Risks (SCENIHR) report, adopted on 25 June 2015.
The revised guidance, available from here, concurs with the SCENIHR conclusions that: "The supply of DEHP-plasticised PVC medical devices is in line with the regulations in circumstances where the clinical benefits outweigh the possible risks and cannot be achieved by other means".