The EU MDR is the set of regulations that governs the worldwide production and European distribution of medical devices. Compliance with this regulation is mandatory for medical device companies to legally market and sell their products in the EEA (European Economic Area). As part of the new regulations, all manufacturers of medical devices for sale within the EU must adhere to more strict guidelines to ensure their products are safe to use.
Additionally, Chemence Medical has obtained certification under the Medical Device Single Audit Program (MDSAP). This is a voluntary programme which allows a single audit of a medical device manufacturer’s Quality Management System to satisfy the requirements of multiple regulatory jurisdictions, including the US, Canada, Australia, Japan and Brazil. There are also options to include ISO 13485 quality certifications as a part of this audit. Audits are conducted by auditing organisations which are authorised by the participating regulatory authorities to audit under MDSAP and ISO 13485 requirements.