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Services for EU market access and ongoing compliance
Non-EU manufacturers often need a single partner who can combine EU presence, structured documentation handling, and dependable coordination across stakeholders. We provide modular services so you can choose exactly what you need, from EU Authorised Representative (EU-REP) coverage to market access planning, technical documentation support, and post-market compliance.
All services are delivered within an agreed scope, with clear responsibilities, defined response routes, and controlled handling of documentation.
EU Authorised Representative (EU-REP)
We act as your EU Authorised Representative in line with the written mandate and applicable EU requirements for your product category. For medical devices and IVDs, the EU-REP role and obligations are set out in MDR and IVDR.
Typical support includes
- EU-REP mandate set-up and structured onboarding
- Defined communication channels and escalation routes
- Controlled availability of required documentation, including access rules and response handling
- Support for regulatory communications with EU competent authorities, aligned to the mandate
- Ongoing coordination throughout the product lifecycle, including change notifications and continuity support
EU regulatory strategy and market access
A clear pathway reduces risk, prevents delays, and avoids costly rework. This is especially relevant in highly regulated sectors such as medical devices, where planning, evidence, and documentation quality directly affect market timelines.
Typical support includes
- Classification and regulatory pathway assessment
- Conformity assessment planning and readiness support
- Gap assessment of technical documentation with a prioritised remediation plan
- Labelling and IFU review support, scope-defined
- Change impact assessments for product updates, documentation updates, and portfolio changes
Technical documentation support
Typical support includes
- Structured documentation review against EU expectations, scope-defined
- Consistency checks across claims, labelling, risk management, and post-market files
- Document structure guidance, practical checklists, and templates aligned to your product scope
- Audit preparation support for inspections and surveillance activities
- Support for documentation governance, including version control routines and update workflows
Post-market compliance support
Compliance continues after launch. We support you in maintaining stable processes and clear records so post-market obligations remain manageable and traceable.
Typical support includes
- PMS set-up support and reporting structure guidance, scope-defined
- Coordination support for vigilance communications, scope-defined
- Economic operator coordination support, including importer and distributor interface alignment
- Feedback-to-CAPA alignment support and escalation workflow set-up
- Support for structured responses to market surveillance questions and documentation requests
Environmental and product stewardship compliance
Typical support includes
- Packaging compliance support, including registration and reporting readiness aligned with EU and national requirements
- WEEE compliance support for electrical and electronic equipment, including country-specific registration pathways and documentation routines
- Battery compliance support aligned with the EU Battery Regulation (EU) 2023/1542, including labelling and information obligations, scope-defined
- Germany-specific support where Stiftung EAR processes apply for WEEE and batteries, including authorised representative requirements where applicable
- Alignment support for the EU Packaging and Packaging Waste Regulation timeline and readiness planning
Product safety, traceability, and market surveillance support
Not every product falls under MDR or IVDR, but EU expectations for safety, traceability, and fast responses still apply. This is particularly relevant for device accessories, clinical and laboratory consumables, wellness and beauty devices, and cosmetics placed on the EU market through importers, distributors, or e-commerce channels. We help you put the right structure in place so you can respond confidently when stakeholders or authorities request information.
Typical support includes
- Product safety positioning and scope check We clarify which EU framework is likely to apply and what this means for documentation, labelling, traceability, and stakeholder responsibilities.
- Traceability and complaint handling that works in practice We implement clear routines for batch and lot traceability, complaint intake, escalation, and decision logging.
- Corrective action and recall readiness We support structured workflows for field actions, customer communications, and regulator-facing documentation, including coordination with EU economic operators.
- Cosmetics documentation and Responsible Person coordination support, scope-defined We support documentation availability and governance for cosmetics and personal care products, and coordination with the EU Responsible Person set-up where applicable.
- Consistency across claims and labelling We review alignment across intended purpose, claims, labelling, and supporting documentation to reduce the risk of avoidable questions or corrective actions.
Other industries
If you operate outside medical devices, we can still support you where EU representation, regulatory documentation, and structured compliance coordination are required. Share your product type and target markets, and we will confirm feasibility and propose a clear scope.