LocaMed Appoints MedEnvoy as Dedicated EU Regulatory Importer

LocaMed Appoints MedEnvoy as Dedicated EU Regulatory Importer

LocaMed, a leading provider of Laparoscopic and Stapling Solutions, today announced the appointment of MedEnvoy as its dedicated EU Regulatory Importer (RI) under the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR).



This strategic appointment underscores LocaMed’s commitment to regulatory excellence, supply chain efficiency, and supporting its European distribution partners with a streamlined, compliant market access pathway.

By appointing a centralised EU Regulatory Importer, LocaMed removes the need for Distributor Partners to act as the legal importer of record, significantly reducing regulatory and legal complexity while improving speed to market.

Key Benefits for EU Distributor Partners

Reduced Legal Liability
MedEnvoy assumes the non-commercial regulatory responsibilities required under MDR and IVDR, including verification of the manufacturer, CE marking, and technical documentation. This substantially reduces the legal and compliance burden placed on Distributor Partners.

Simplified Labelling & Logistics
With a single, centralised Regulatory Importer identified on product packaging, Distributor Partners avoid complex, country-specific labelling requirements. This eliminates the logistical challenges associated with managing multiple importers across different markets—often described as a “logistical nightmare” when scaling distribution networks.

Faster Market Access
A specialised Regulatory Importer ensures regulatory compliance is consistently met, helping to prevent customs delays and enabling smooth, efficient, and reliable supply chains throughout the EU.

Greater Focus on Sales and Growth
Distributor Partners can concentrate on commercial activities rather than investing in costly Quality Management Systems (QMS) and internal processes needed to manage regulatory documentation and importer obligations.

Streamlined Compliance & Traceability
MedEnvoy manages product registration in EUDAMED and maintains robust traceability processes, further easing the regulatory workload for Distributor Partners while supporting ongoing compliance.

“Partnering with MedEnvoy as our EU Regulatory Importer strengthens our European distribution model and reinforces our commitment to compliance, efficiency, and distributor support,” said Paul Blenkinsopp, CEO at LocaMed. “This approach allows our partners to focus on what they do best—bringing high-quality Laparoscopic and Stapling solutions to patients.”