The survey further shows that 53% of manufacturers report that they are unable to sign with a Notified Body to certify their quality management systems and IVDs. SMEs are disproportionately affected by the lack of Notified Body – 64% of SMEs do not have a contract with even one Notified Body compared with 25% of large manufacturers who do not. There is a ~10-fold increase in the number of tests needing Notified Body certificates under the IVD Regulation as compared to today’s IVD Directive (see Figure 2). While Notified Body capacity was cited by respondents as a top concern, it was not the only infrastructure challenge. 74% of manufacturers who responded to the survey reported issues in starting or completing certification.
MedTech Europe has previously called on EU decision makers to urgently find solutions that give the IVD regulatory system sufficient time to be ready to operate. Any such solution must first ensure that a minimum viable infrastructure is in place, including ensuring sufficient Notified Bodies are designated.
MedTech Europe members are strongly committed to complying with the IVD Regulation but can only do so when the new regulatory system is operational and allows for it. This survey indicates how urgent the need is for EU decision makers to take action on the IVDR regulatory framework and the fast-approaching date of application, to safeguard and support medical diagnostics in Europe.
Source: MedTech Europe
Source: Healthcare in Europe