MDR, UDI & IVDR Labelling Solutions for Regulated MedTech Environments
Compliance isn’t a label — it’s a system
For MedTech manufacturers, regulatory compliance extends far beyond the device itself. Labelling is a critical part of your regulatory framework, impacting traceability, audit readiness and patient safety. IMS Labels supports MedTech companies across Ireland, the UK and Europe with MDR, UDI and IVDR labelling systems designed for real production environments, helping you meet regulatory obligations without disrupting operations.
Understanding the regulatory landscape
MDR and IVDR introduced a new level of complexity to medical device and IVD labelling, including:
- Mandatory Unique Device Identification (UDI)
- Multilingual labelling requirements
- Expanded data fields
- Greater traceability across the supply chain
These requirements affect not only what appears on a label, but how data is generated, controlled and updated across your organisation.
More than labels — a compliance-ready system
Our MDR, UDI and IVDR solutions go beyond print. We provide an end-to-end framework that supports:
- Multiply, booklet and leaflet labels
- Industry-grade printers and consumables
- Intuitive label software
- IERP integration for data accuracy
- Scalable workflows for production environments
Built for production, audits and change
This allows compliance to become part of your operational infrastructure — not an afterthought.
Regulatory environments are dynamic. Requirements evolve. Products change. Languages expand. Our approach is designed to support:
- Controlled updates
- Version management
- Audit readiness
- Repeatable production
- Cross-site consistency
A partner for regulated manufacturing
In regulated industries, the cost of error is high. Your labelling partner should reduce risk — not introduce it.
- Experience across MedTech environments
- Understanding of audit and validation pressures
- Systems designed for traceability
- Long-term support and continuity
Talk to a compliance labelling specialist
If you’re implementing or refining MDR, UDI or IVDR labelling, our team can help you define a compliant, scalable solution for your environment.
