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EU Regulatory Reads, June 2018: Experts Tell Industry To Get Moving Despite Shortfalls – Shift Later!
Pressure is building on companies to start compliance efforts to the EU Medical Device Regulation. But a good deal of naivety remains in industry, and those who delay may lose out badly, experts warned in Medtech Insight articles throughout the month of June.
Medtech manufacturers must begin taking strides toward compliance with the EU Medical Device and IVD Regulations now. That has been the overriding message from experts, who are urging action from industry even though many of the basic regulatory structures are not in place and many critical questions remain unanswered.
“Companies need to get a move on now, even if it means having to shift paths later when new information is available,” Hans Heiner Junker, senior international affairs manager at notified body TÜV-SÜD Product Service, told delegates at Knect 365’s MedTech Summit in Brussels in mid-June.
His message was reiterated on the first day by several top experts, including Gert Bos, executive director and partner at Qserve consultancy group, who spoke one-on-one with Medtech Insight to warn companies about the harsh realities of trying to comply with the EU’s new Medical Device and IVD Regulations in the current environment.
In part one of the interview, Bos predicted that there may be just 10 notified bodies by the end of 2019 – when there will be less than five months to go until the EU MDR full applies.
So how would the sector manage just as game-changing new regulations become mandatory but there are only around a sixth of the current complement of notified bodies? Bos warns how Brexit uncertainty is compounding this problem. “What is clear at this stage is that nobody knows” the future of UK notified bodies, he said.
In part two of the Q&A, Bos warns that lack of clarity over what is sufficient clinical data under the new regulations is paralyzing company efforts to collect data, as regulatory staff struggle to justify the extra spending to management . The level of uncertainty high enough, he revealed, that some companies are unwilling to commit to five-year tenders with hospitals.
Four-Year Grace Period Not So Attractive?
As the sector has time to study the texts and the situation more closely, new facts are emerging that could impact company decision-making on matters as critical as whether to retire products or not.
There has been more speculation as to the value of making use of a grace period in the regulations, the derogation extension of up to four years after May 26, 2020 (the date on which the Medical Devices Regulation fully applies) for products that are CE-marked under the current directives.
To date, companies have been told that their decision-making should focus mainly on the issue of whether there would be significant design changes to their products – a very subjective matter. But discussions at last month’s MedTech Summit in Brussels revealed that there are obstacles to using the extension period, which may make companies decide to comply with the MDR earlier than they were intending or retire products altogether. Companies are being warned that notified bodies, overwhelmed with work, may well choose an early cut-off for reviewing against the directives and that registration costs could be very high.
Despite this, Bos predicted that most products will be eligible to benefit from the grace period at first. But he warned that this will drop very quickly, with less than 50% eligible after two years.
Companies Having Unfair Advantage?
Another piece to arise from the MedTech Summit focused on the controversy over notified bodies conducting mock audits of client manufacturers. It seems that the rules around mock audits have been less than clear and that different notified bodies have interpreted them differently. The result is that some companies are resentful that they may be missing out on an opportunity that competitors are leveraging.
Sources close to the European Commission have since told Medtech Insight that the Commission feels it has the power to act if it believes that a notified body has acted inappropriately in this respect. It seems that any overstepping the mark will be transparent during joint audits of the notified bodies. The article on mock audits has just been updated in the light of these most recent points.
EU And US: Sunshine Rules and Personalized Medicine
When it comes to differences between EU and US rules for sunshine products, lawyers at Hogan Lovells point out that national differences in the EU, as well as differences with the US, make it difficult for companies to prepare a single one-size-fits-all response to sunshine rules.
And when it comes to personalized medicines, in a separate article, Hogan Lovells’ lawyers predict the pathways for these types of products, and the new levels of scrutiny under the EU regulatory scheme, compared with the less defined rules in the US and legislative ambiguity, are going to cause the two systems to differ. The attorneys explained how the regulation of and reimbursement of personalized medicine might change in Europe.
Attorneys also speculated last month about how the European Commission’s HTA proposal may offer future opportunities toward EU-wide consideration of the value of personalized medicine.
But we reported later in the month on Council of the EU’s dismissal of the European Commission overall approach. That is likely to seriously delay the HTA proposal as it makes its way through EU negotiations. The outcome could determine the market viability of many highly innovative products, experts say.
This month we also gained feedback from a survey of Swiss SMEs. One-third of the respondents are intending to change notified body and two-thirds of respondents also feel that the implementation of the EU’s Medical Device Regulation will not improve patient safety. This survey comes hot on the heels of one made public in May.
In the coming days, look out for the latest on how consensus standards are being updated so that they are compliance with the new EU regulations. There are signs that the European Commission has delayed too long and that the medtech standards management structure and the notified bodies are going to be under considerable pressure.