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Self-care medical devices may be included in the four-year “grace period” following implementation of the new EU Medical Device Regulation as part of an incoming corrigendum to the law, a spokesperson for the European Commission suggested at a recent AESGP meeting.
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The EU MDR represents the biggest collective change in many years for medtech companies in terms of how they prepare their approach to market. With time running short for companies’ preparations ahead of the regulation’s implementation date of 26 May next year, the UK ABHI’s final pre-MDR regulatory conference in late October will be both a check list for companies en route to compliance and a debate about the wider role of risk in regulatory compliance.
The tightening of the EU regulatory system will increase timelines for the availability of devices, especially novel, high-risk devices. But those who believe the US system will be quicker should not be so eager to jump to conclusions. Clinical data expert Sarah Sorrel explains why.
The Brexit withdrawal deal agreed by the UK and the EU on 17 October would see the UK leave the EU at the end of the month, but would allow time to negotiate the future trading and regulatory relationship between the two parties. However, the deal still faces a rough passage in the UK parliament.
Today is John Wilkinson’s last day as head of devices at the UK’s MHRA. It looks like his successor will be someone who can ably assist in the transition ahead, as the UK copes with upcoming Brexit arrangements and the EU attempts to successfully implement the new Medical Device and IVD Regulations.
A review of German insurance data found no additional risk of death in patients treated with drug-coated balloons and stents, even in patients who had the devices for more than a decade. The data appears to further challenge a bombshell meta-analysis that claimed paclitaxel could increase death rates by up to 90%.
Forthcoming requirements under the EU’s new Medical Device Regulation are creating upheaval for the medicinal products industry, unaccustomed to engaging with notified bodies and unfamiliar with the loose timelines that the medtech industry operates within. Will an increase in joint working, joint documents and general crossover between the drug and device sectors smooth the way?
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