EU MDR Compliance for Legacy Medical Devices: New Guidance
Legacy devices are products that were legally certified under older directives (MDD) but are allowed to remain in EU market. The EU MDR has released new guidelines for legacy devices. Legacy devices will have to mandatorily comply with these guidelines to...
EU Authorized Representative: Roles & Responsibilities
An EU authorized representative is a legal entity in EU that non-EU manufacturers must appoint to act on their behalf. The authorised representative serves as the official contact point with EU authorities. It verifies that technical documentation and declarations of...
EU MDR Technical Documentation: Purpose and Contents
EU MDR technical documentation is the backbone of compliance for medical devices in Europe. It must comprehensively demonstrate conformity with EU medical device regulations and its documentation requirements. The MDR technical documentation must be prepared before...