Compliance Management Solutions Europe
Medical device manufacturers seeking access to the European Union market must comply with the regulatory obligations of MDR (EU) 2017/745, including the appointment of a compliant EU Authorised Representative and, where applicable, an EU Importer. Compliance Management Solutions Europe provides integrated EU Rep and EU Importer services designed to support lawful market access, regulatory continuity, and post-market compliance.
As an EU Authorised Representative, Compliance Management Solutions Europe fulfils the responsibilities outlined in Article 11 of the MDR, acting as the manufacturer’s official regulatory presence within the EU. We support manufacturers by verifying the availability and completeness of technical documentation and Declarations of Conformity, maintaining regulatory records, facilitating communication with Competent Authorities and Notified Bodies, and supporting vigilance and post-market surveillance activities.
In the role of EU Importer, Compliance Management Solutions Europe performs the verifications required under Article 13 of the MDR prior to placing devices on the EU market. This includes confirmation of CE marking, labelling and UDI compliance, registration obligations, and cooperation with EU market surveillance authorities where required.
Our approach is structured, risk-based, and lifecycle-focused, ensuring regulatory obligations are integrated into the manufacturer’s existing quality and regulatory systems. With experience across EU MDR, UK MDR, and international regulatory frameworks, Compliance Management Solutions Europe enables manufacturers to leverage existing compliance assets while meeting EU-specific legal requirements efficiently and reliably.
By appointing Compliance Management Solutions Europe as your EU Authorised Representative and EU Importer, you gain a trusted regulatory partner committed to protecting compliance, supporting post-market obligations, and safeguarding your continued access to the European medical device market.
Contact us now.
gloizou@compliancems.com.au