The rapid spread of COVID-19 has placed an unprecedented strain on the global demand for personal protective equipment (PPE).
The European Union has enacted emergency measures and reinforced its arsenal of guidance documents to address shortages and increase the availability of PPE and medical devices on the EU market. Extraordinary measures have also been taken to restrict exportation of certain PPE and remove regulatory barriers by simplifying certification and market surveillance procedures.
This white paper provides an overview of the legal framework and discusses key regulatory developments with a bearing on safety requirements, testing, certification and labeling of PPE.
Author: Celia Le Lievre, Regulatory Compliance Specialist at Compliance & Risks.