The European Union had recently proposed doing what the medical device industry has been urging for years – delaying the implementation of certain aspects of the In Vitro Diagnostic Medical Devices Regulation (IVDR) that is slated to replace the current In Vitro Medical Devices Directive (IVDD). That proposal was adopted in December 2021.
One of the primary challenges has been bringing Notified Bodies (NB) online in a timely manner, which has caused a great deal of concern within the industry. So far, just six (6) Notified Bodies have been designated under IVDR, with 11 applications pending (as of October 2021), compared to 27 designated under MDR. In summary, there is a grave shortage of notified body capacity, making it difficult for manufacturers to conduct the legally required conformity assessment procedures in time. As the currently designated Notified Bodies are established in only three (3) countries (Germany, France and the Netherlands), the situation is particularly problematic for SMEs established in other Member States, which have a tendency to apply to Notified Bodies in their own or neighboring Member States.
European medical device industry association, MedTech Europe, conducted a recent survey that revealed a significant problem if the original regulation implementation schedule is kept. According to the survey, as much as 22 percent—and perhaps more—of diagnostic tests currently on the market would be lost in the IVDR transition if the rollout had not been delayed.
Under the new transitional provisions, the regulation's two-year transitional phase will be extended by one (1) to three (3) years, with the compliance period extending to May 2027 for the lowest risk devices, giving test makers more time to get their products certified and allowing for more notified bodies to come online before the regulation takes effect. However, only devices that require a notified body certificate already under the current IVD Directive (approximately 8%) would benefit from this existing transitional provision.
According to the European Commission proposal, the IVDR itself is not postponed—the general date of application is still May 26, 2022, and it “will apply in full … to CE marked in vitro diagnostic medical devices that do not require the involvement of a notified body.” Such devices include class A non-sterile devices and new IVDs that are not covered by a certificate or a manufacturer's declaration of conformity issued prior to the IVDR entering into force.
There are two other important milestone dates: May 26, 2024 is the last possible date for placing devices on the market according to the IVDD (i.e., if not already expired IVDD Notified Body certificates are void); and May 26, 2025 is the last possible date for putting devices into service according to the IVDD.
IVDs that would be self-certified or self-test under the IVDD but that would require Notified Body certification under the IVDR will have more time:
- May 26, 2022 for Class A, self-certified – sell-off period until May 26, 2025
- May 26, 2025 for Class D – sell-off period until May26, 2026
- May 26, 2026 for Class C – sell-off period until May 26, 2027
- May 26, 2027 for Class B – sell-off period until May 26, 2028
- May 26, 2027 for Class A, sterile – sell-off period until May 26, 2028
There are many moving parts to this new timeline, and they will directly impact you as a manufacturer. The IVDR additional transitional periods are necessary to avoid disruption in the supply of essential in vitro diagnostic medical devices. Otherwise, the diagnosis of patients and their access to relevant health care could be at risk. It is estimated that around 70% of clinical decisions rely on in vitro diagnostic medical devices. There is no question that IVDR is coming, only when. The partial implementation delay does not stall your need to prepare for this regulatory change. To minimize your compliance risk, call us for regulatory consulting on all of your IVDR transition needs.
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MEDIcept is an international consulting firm offering a full portfolio of services to the medical device and IVD industry. For over 25 years, our unique consulting practice and multidisciplinary team of former FDA, Notified Body, and industry experts have assisted hundreds of companies of all sizes with innovative, compliant, trusted, and cost-effective Regulatory, Quality, Clinical, and Engineering solutions.
For additional information, please contact Susan Reilly at SReilly@MEDIcept.com