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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.
MedTech Europe issues press statement ahead of upcoming trilogue negotiations
6 October 2015
MedTech Europe, the alliance of European medical technology industry associations EDMA, representing the European in vitro diagnostic industry, and Eucomed, representing the European medical devices industry, has issued a press release ahead of the forthcoming trilogue discussions on the two regulations that will take the place of the three current European device directives. The trilogue negotiations are due to start on 13 October, with four further meetings scheduled before the end of the year.
The press release calls for a "focus on clarity, applicability and feasibility in order to strengthen patient safety" while not discouraging innovation within the sector, highlighting several areas within each of the draft regulations that the association considers may not achieve improved levels of patient safety.
Serge Bernasconi, CEO of MedTech Europe, is quoted as saying: “We need this regulation, but policy makers must ask themselves: does each new measure see a real increase in patient safety, help rather than hinder needed innovation for patients and avoid unnecessary complexity for SMEs and regulators?” One would hope that this would have been the key to all the changes proposed, but unfortunately, politicians and regulators don't always take such a scientific, analytical approach.
For the medical devices sector, Eucomed has stressed the need to ensure that the EU provides improved levels of patient safety across Europe by addressing five areas of concern:
The newly added scrutiny mechanism is still, in industry’s view, redundant in light of other improved measures. Despite our recommendations, if this mechanism is added it must be made workable and predictable.
The case-by-case approach of clinical evaluation should be improved by getting the definitions of clinical data and clinical equivalence scientifically sound.
A single rather than multiple high harmonised level of safety must be ensured for re-use of Single Use medical devices with hospitals and subcontractors appropriately covered.
Ensure hazardous substances, when used in a device providing an overall positive risk ratio, are controlled and labelled by actual risk of exposure and not just ‘hazard’.
Unnecessary complexity and disproportionate measures must be eliminated by stripping out unfeasible, disproportionate or duplicative requirements, especially in fitting well-established technologies into the current system and by reversing unjustified re-classifications.
A copy of Eucomed's position paper on the topic is avaialble from here.
For the IVD sector, EDMA has already published a position paper on the elements it wants to see improved, reported previously on this site.
While not mentioned in the MedTech Europe press release, there is also concern among Notified Bodies, medtech lawyers and industry representatives about the unnecessary change to the product liability status quo proposed by making European Authoised Representatives, who are not part of the supply chain, "legally responsible" for defective products, despite that fact that the European Product Liability Directive has for over 20 years identified only those economic operators in the supply chain as having liability.
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.