When it comes to innovation, Europe has a thing or two it can learn from the U.S. according to European leaders. Speaking at the Medtech Forum meeting in Barcelona, Medtech Europe CEO Serge Bernasconi said Europe’s focus on safety issues is stifling innovation across the continent.
As the implementation date of In Vitro Diagnostic Regulation (IVDR) looms on May 26, 2022, significant uncertainty remains around the new regulatory system. Under Directive 98/79/EC around 10% of all IVDs placed on the market need notified body involvement, whereas under the IVDR this will rise to 80%-90%. Notified body shortages continue to be a major challenge for industry, with many manufacturers yet to receive certification. The situation is expected to be particularly problematic for SME manufacturers who will see most of their products blocked on the market if they don’t receive validation in time.
The European Commission has acted to thwart cybersecurity risks with a proposed cybersecurity regulation and separate proposal for information security. What is not clear, however, from these proposals is whether they would interact with existing EU rules governing cybersecurity for medical devices, raising the prospect that medical technologies will be subject duplicate oversight for cybersecurity.
The implementation date for the European Union’s In Vitro Diagnostic Regulation (IVDR) is a mere 16 months away, although there is widespread interest in a delayed implementation date. Nonetheless, Warren Jameson, principal regulatory consultant for North American Science Associates (NAMSA) of Toledo, Ohio, urged test makers to conduct a gap analysis of the conformity of their currently marketed tests to the new regulations because a large percentage of the underlying dossiers would not pass muster under the terms of the new regulatory regime.
DUBLIN – The ongoing legal uncertainty surrounding the transfer of data from European research institutions or companies to international partners shows little sign of resolution, despite the urgency of the COVID-19 pandemic, which has engendered an extraordinary collaborative response from the global scientific community.
LONDON – The EU is to set up an equivalent to the U.S. Biomedical Advanced Research and Development Authority (BARDA), after coming under criticism from pharma companies about Europe’s inability to swiftly seal advance purchase agreements for COVID-19 vaccines. The plan was announced on Sept. 16 by European Commission President Ursula von der Leyen, in her first state of the union address since coming into office at the start of 2020. The new agency will support capacity and readiness to respond to cross-border health threats and emergencies, “whether of natural or deliberate origin,” she said.
LONDON – The EU launched a “Corona” response team, bringing together oversight of all the separate strands put in place to control the virus, as the infection spread to 18 of 27 member states, with 2,100 confirmed cases and 31 deaths.
LONDON – The EU launched a “Corona” response team, bringing together oversight of all the separate strands put in place to control the virus, as the infection spread to 18 of 27 member states, with 2,100 confirmed cases and 31 deaths.
As the U.K. pursues its divorce from the EU, smaller U.S. drug and device companies could be caught disproportionately in the collateral damage. Many of them already struggle with the cost of duplicative regulatory requirements involved in marketing their products in the EU, but those costs could increase under Brexit, according to a report released last week by the U.S. International Trade Commission on trade-related barriers impacting U.S. small- and medium-sized enterprises (SMEs) that export to the U.K.
