The COVID-19 pandemic is changing priorities in the health sector worldwide and the relevant market for medical devices, about two months before the planned implementation of the new Medical Devices Regulation, MDR 745/2017, on 26.5.2020.
The European Organization MedTech, (European Association of Medical Technology Industries), proposes postponement of the regulation, review and definition of the new implementation date, at least 6 months after the end of the pandemic, as it will be set by the World Health Organization (WHO).
MedTech said the industry is “working relentlessly” to manufacture and distribute medical devices to be used in the fight against COVID-19 while exerting efforts to secure the supply chain is provided with all other necessary medical products.
Executing of the above-mentioned tasks by the industry in the health sector “severely disrupts” compliance efforts to implement the new regulation, which urgently necessitates its postponement to ensure that the health system is provided with the necessary supplies, for the fight against the COVID-19 pandemic.
Even though the European Commission’s decision is pending, TÜV AUSTRIA Hellas’ specialized staff remains alert to developments in order to provide valid and timely information to its customers.