Concerns raised over lack of IVDR prepareness
MedTech Europe has flagged concerns over the implementation of the IVDR framework which is due to take effect in 2022. The trade association is ‘raising the alarm’ over a lack of preparedness for the implementation of the policy across Europe. Guidance documents, EU reference laboratories and common specifications which are key to the implementation of regulatory policies do not currently exist according to the organisation. MedTech’s CEO Serge Bernasconi said that “MedTech Europe and the diagnostics industry are ready to fully engage in discussions with authorities and stakeholders to find workable solutions, and make the implementation of the new IVD framework successful.”
COVID-19 has meant a distraction for health authorities, EU member states, laboratories and health institutions away from focussing on the implementation process in advance of 2022 for the IVDR. The medicines framework, MDR, has been postponed due to the virus and will now come into force in 2021, rather than this year. The IVDR will take effect on the 26 May 2022, without any alteration to its implementation stages. Both entered into their respective three- and five-year transition periods after being adopted by the EU on 26 May 2017. MedTech has stated that an ‘immediate dialogue’ must now take place with relevant stakeholders in order to act against this public health challenge and to ensure that the appropriate steps are taken in preparation for the regulation change. MedTech also claimed notified bodies, which assess whether manufacturers and their medical devices meet European regulations, must be re-designated due to the “considerably strengthened requirements” that will come with the new IVDR policy.