MedTech Europe, the trade association representing the medical technology industries, has reiterated calls for the EU to delay the implementation of the In Vitro Diagnostics Regulation (IVDR) (EU) (2017/746).
In July, the trade association called for a delay in the implementation of the IVDR, which is set to come into force on 26 May 2022.
MedTech Europe (correctly in our view) noted that the practical deadline for infrastructure to be fully established was 2020. In reality, manufacturers must commence the conformity assessment by the start of 2021 in order to achieve the May 2022 deadline. Most stakeholders are of the view that this unachievable and is likely to result in “catastrophic disruption”.
MedTech Europe highlighted a litany of gaps in the infrastructure, including the lack of Notified Bodies, EU reference laboratories, Common Specifications and implementation guidance from the MDCG (which has only recently been published). If anything, delaying the implementation of the Medical Devices Regulation (MDR) (EU) (2017/745) by 12 month will likely compound problems.
“Since most authorities and several notified bodies are shared between MDR and IVDR, the reduction of the timeframe between the implementation of MDR and IVDR amplifies the already existing bottleneck in resources”.
In November, MedTech repeated the concerns set out in the paper published in July. They specifically note that approximately 45,000 in vitro diagnostics (IVDs) require certification before the regulation comes into force in May 2022 and that there were currently only four designated Notified Bodies to handle this Tsunami. We note that this number has briefly increased to five Notified Bodies but as things stand will drop back to four following the end of the Brexit transition period.