Regulatory Importer Services
(EU, UK, Switzerland)
Medical device and IVD manufacturers often enter the EU, UK, or Swiss markets through distributors. Those markets also place specific duties and legal obligations on the importer for products entering the market.
AJW Technology Consultants, Inc. provides Regulatory Importer Services through our EU, UK, and Switzerland offices. Our importer service focuses on labeling verification, documentation review, traceability support, and the importer activities required under the applicable regulations.
When an Importer is Required
- Your manufacturing entity is located outside the EU, UK, or Switzerland
- You're placing devices on the market in these jurisdictions
- You lack a local legal entity established in the jurisdiction
The importer verifies compliance before products reach the market and maintains ongoing obligations for post-market surveillance, reporting, and traceability.
“Why do I need an importer if I already have distributors?”
In the EU, importer obligations sit alongside distributor obligations.
Under Article 13 EU MDR and Article 13 EU IVDR, the importer performs defined checks before placing devices on the market. Many distributors prefer to operate as distributors and ask the manufacturer to appoint a separate EU MDR importer / EIVDR importer that carries importer duties.
How AJW Tech Importer Services Work
Independent Importer Role
AJW Tech acts as the regulatory importer focused on compliance verification and importer obligations. The commercial supply chain can remain with your distributor(s), 3PL, or logistics provider.
Remote Compliance Verification
We run importer checks tied to documentation review and labeling verification. We coordinate with the manufacturer and, where applicable, the Authorised Representative, the UK Responsible Person, or the Swiss Authorised Representative.
Market Access Support That Fits Your Model
Manufacturers keep control of pricing, channels, and customer relationships. AJW Tech supports market access by carrying the importer role required for compliant placing on the market.
Market Requirements by Region European Union
EU MDR 2017/745 Article 13 and EU IVDR 2017/746 Article 13 define importer obligations for devices placed on the EU market. Our Düsseldorf office serves as your designated EU importer.
- Verify EUDAMED registration, CE marking, declaration of conformity, technical documentation, and UDI compliance.
- Review instructions for use (IFU) and verify labeling includes manufacturer, authorized representative, and importer contact details.
- Verify the documented requirements for storage and transportation are defined and used in your distribution setup.
- Maintain complaint registers and report serious incidents and field safety corrective actions to authorities.
- Maintain supply chain traceability and coordinate with your authorized representative.
United Kingdom
The UK established independent medical device regulations under UK MDR 2002 (as amended) following Brexit. Our London office serves as your designated UK importer.
- Verify MHRA registration, UKCA marking (or CE marking during transition periods), and declaration of conformity.
- Verify UK Responsible Person on labeling and review instructions for use and accompanying information.
- Verify labeling includes manufacturer, UKRP, and importer contact details.
- Handle complaint registers and vigilance reporting to MHRA.
- Maintain supply chain traceability and coordinate with your UK Responsible Person (UKRP).
Switzerland
Swiss medical device regulations under MedDO (SR 812.213) and IvDO (SR 812.219) require importers for non-Swiss manufacturers. Our Zurich office serves as your designated Swiss importer.
- Verify SwissMedic registration, conformity assessment documentation, and Swiss authorized representative on labeling.
- Review instructions for use and verify labeling includes manufacturer, Swiss Authorised Representative (AR), and importer contact details.
- Handle vigilance reporting to SwissMedic.
- Manage complaint handling and adverse event coordination.
- Maintain supply chain traceability and coordinate with your Swiss authorized representative.
Contact AJW Tech About Importer Services
If you are placing medical devices or IVDs in the EU, UK, or Swiss markets and need a regulatory importer with local offices to assume importer obligations, contact AJW Tech.