The European Union is proposing to delay the go-live date for the incoming medical device regulation pertaining to In Vitro Diagnostics (EU) 2017/746 (IVDR) for products that still need assessment of a notified body, which would allow some manufacturers more time to prepare for compliance to the new Regulation and secure Notified Body support. The proposal still has to be confirmed by European Council and Parliament. It is, however, broadly expected that it will be adopted.
The medical device industry has long pushed for the EU to delay IVDR, warning that the new regulation is more disruptive to the market for diagnostics than its counterpart Medical Devices Regulation (MDR), which itself was delayed by one year a month before its original date of application in May 2020 due to COVID-19.
While EU authorities had long insisted that no such delay would be granted for IVDR, the slow pace of notified body designations and concerns within industry raised the specter of widespread test shortages. So far, just 6 notified bodies have been designated under IVDR, with 11 applications pending, compared to more than 20 designated under MDR. The number of manufacturers in need for a notified body would increase dramatically under the IVDR because – due to the change of the classification system – an estimated 80 to 90% of manufacturers would be subject to notified body certification whereas this is the case for only 10 to 20% under the IVDD.
Given the fact that the European health institutions are and will be strained by the COVID-19 pandemic, the Commission apparently did not want to risk essential IVD medical devices to disappear from the market.
Under the proposal, the regulation’s 2-year transitional phase would be extended by 1 to 3 years, with the transitional 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.
Key points of the proposal
Now the question is what exactly has been proposed? We have briefly summarized the most important points below.
– First of all and most importantly, the Commission does not propose a delay of the IVDR. The regulation will still fully apply as of May 26, 2022 and thus become the general legal framework for IVD medical devices.
– Depending on the IVDR risk class that would apply under the IVDR, extended transition periods may apply for devices that did not require notified body involvement under the IVDD and for which the declaration of conformity was drawn up before May 26, 2022:
– Class A sterile and class B devices may continue to be placed on the market or put into service under the IVDD until May 26, 2027.
– Class C devices may continue to be placed on the market or put into service under the IVDD until May 26, 2026.
– Class D devices may continue to be placed on the market or put into service under the IVDD until May 26, 2025.
– Class A devices not requiring notified body involvement under the IVDR will have to fully comply to the IVDR as of May 26, 2022.
– Manufacturers who may make use of the extended transition period must still comply to the IVDR requirements on PMS, vigilance, economic operator and device registration as of May 26, 2022.
– Manufacturers who may make use of the extended transition period may not implement any significant changes to the device design or intended purpose. This may be especially challenging for software devices.
– Manufacturers with notified body certificates issued under the IVDD may continue to place their products on the market under the IVDD until the certificate expires under the conditions referenced above.
– In addition, the Commission has proposed a deferred application of the requirements for devices manufactured and used within the same health institution, so called “in-house devices”.
The proposal now heads to the European Parliament and Council for adoption and will take effect upon publication in the Official Journal of the European Union.
Source: https://ec.europa.eu/commission/presscorner/detail/en/ip_21_5209