Regulatory bottlenecks mean EU clinicians and patients could lose access to medical devices under new rules European clinicians and their patients could lose access to vital medical devices, including in-vitro diagnostics, due to a lack of agencies able to certify products in time to comply with strict new regulations. A particular concern is in-vitro diagnostic devices (IVDs), used to perform tests on samples such as blood, urine and tissue. Whereas only about 7 per cent of in vitro diagnostic devices required clinical evidence for approval under existing EU IVD directives (IVDD), 85 per cent will now need it under IVDR, an increase of almost 80 per cent. All 500,000 existing medical devices currently on the EU market must be recertified under new Medical Device Regulations (MDR).
There is significant concern that tight deadlines and the lack of notified bodies (NB) may result in devices not being recertified. As of late August, only 2 of 58 existing notified bodies (NBs) have been designated to operate under the European Union’s MDR and zero for IVDR, causing a regulatory bottleneck.” With one NB located in the United Kingdom, BSI-UK, its status is uncertain in the face of Brexit; although, they have established an office in the Netherlands (BSI-UK) where Dutch authorities indicate transitioning designation out of the UK should be seamless. About 80 percent of NBs operating under existing EU medical device directives had applied for MDR by December 2018, but the certification process is complex, and only a handful are anticipated to be designated this year. ICON’s a white paper ‘Higher Costs and Bottlenecks’ outlines steps medical device and in vitro diagnostic developers must address to maintain market share and in the longer term, develop and maintain financially viable product portfolios.
· Overcoming the growing shortage of NBs
· Addressing new clinical data requirements under MDR and IVDR
· Developing a global market entry strategy to capitalize on opportunities
· Considering launching new products in the US and other countries
· Involving top management in compliance efforts