Remote audits, MDR postponing and EC certificate recognition.

The pace and geography of the spread of coronavirus infection has been a source of tension for the world community for the several last months. Many countries have closed borders and restricted traffic within the country as preventive measures for the spread of COVID-19.

At a time of acute need for medical devices, new challenges to certification bodies arise for on-site audits, including annual surveillance, recertification and variations/extensions. Difficulties in planning and forecasting current and new processes were experienced by all market operators: conformity assessment bodies, manufacturers, distributors and importers. Previously we informed on the decision to postpone audits in countries with outbreaks until May-June 2020.

That situation has almost no impact on medical devices assessed through an EC certificate recognition route. Remote communication between bodies of the EU and Ukraine allows obtaining data on the quality management system of those products, the efficiency and safety of which was assessed and certified in Europe.

According to our information, today there are agreements on recognition with 30 EU notified bodies. National conformity assessment with partial recognition allowed to maintain stability in the regulatory field since the beginning of 2020, when it became impossible to conduct on-site audits, remaining a fast, transparent and cost-effective way to place products to the market of Ukraine.

At the same time, the recognition procedure requires continuous monitoring of regulatory requirements not only on the national but also on the external market. May 2020 should be decisive in the implementation of MDR provisions in the EU. On March 25, the European Commission announced the amendments to MDR postponing the mandatory application date for one year. In case the amendments are adopted by the Parliament and Council of the EU, the MDR implementation date will be extended by one year.

The remote audit, as one of the alternative mechanisms for conformity assessment, was listed in the Statement of the International Accreditation Forum (IAF). The National Accreditation Agency of Ukraine (NAAU), being an associated member of the IAF, supported the possibility of conducting remote audits during quarantine in Ukraine.

Remote audit does not bypass the conformity body’s assessment works and the requirements of the chosen conformity assessment route – remote audit is an alternative way to conduct an assessment in the inability for on-site audit. The procedure should follow the requirements of ISO 13485, ISO/IEC 17021, ISO/IEC 17065, as well as IAF MD 4, IAF ID 3:2011, IAF ID 12 and others.

According to our information, national conformity assessment bodies have already developed and implemented relevant methods and obtained the necessary approvals. Please note that remote audits are a temporary measure related to emergency events in Ukraine and the world.

Conducting remote audits requires extensive preparation, completely new legal and organizational actions, additional solutions to data privacy and more. Cratia supports a balanced and professional approach to remote audit and offers assistance in it’s preparation and organization.