The role of expert panels under the EU’s Medical Device Regulation in adopting opinions for innovative high-risk devices is well established. But manufacturers can benefit now from a second swathe of opportunities as these groups continue to gear up to also provide scientific advice.
The European Medicines Agency (EMA) is inviting EU-based manufacturers or their authorized representatives to apply for a second phase of the pilot program where expert panels provide free scientific advice for manufacturers of innovative high-risk medical devices.
Manufacturers should apply by 15 September via EMA's ServiceNow portal.
Despite staffing cuts and uncertainty at the FDA, the US still offers EU medtech firms stronger regulatory support, regulatory expert Bassil Akra told Medtech Insight. This is especially valued as EU rules are often viewed as overly stringent, unclear and difficult to follow.
2026 reimbursement calculations for the list of hybrid DRGs – a mechanism to incentivize day cases over inpatient surgery – will be issued in few weeks’ time. The medtech industry has made its demands known.
Daye is launching an at-home reproductive hormone testing service in the UK, utilizing a painless upper arm blood collection method. The product’s UKAS lab accreditation helps build credibility with healthcare providers.
EU4Health, the main funding instrument for EU health initiatives, has put renewed emphasis on orphan devices in its 2025 work program, published in July.
The US FDA posted three warning letters in July, covering medical supply kits, wearables and orthopedics.
Hopes that last-minute negotiations might exempt Brazil’s $300m medtech exports from the latest round of US tariffs have been dashed, leaving the industry braced for further market instability that countermeasures could trigger.
Medical device firms often have serious compliance gaps, a recent Veeva MedTech survey found. Only 50% of the companies surveyed are confident in their global registration data, with 70% reporting inconsistencies during audits. The report recommends automation and better data governance.
