The medical technology industry is growing rapidly. Stay on top of regulatory requirements with confidence

Projected MedTech sales by 2030
Predicted annual growth rate for the global MedTech market
Countries TÜV Rheinland serves in MedTech testing & certification
Medical technology patent applications in Europe (2022)

Your Benefits with TÜV Rheinland

Biotech researchers analyzing genomic data via AI-driven molecular sequencing in a smart lab, optimizing high-throughput drug discovery workflow.

  • Trusted for Quality and Safety

    Our independent certification shows that your IVDs meet the highest standards – building trust with regulators, healthcare buyers, and patients.

  • Clear Compliance, No Surprises

    As an IVDR Notified Body, we translate legal requirements into clear, actionable steps – so your team always knows what to do next.

  • Faster Timelines, Proven Results

    Efficient project setup, dedicated contacts, and fast lab turnaround keep your certification process on track – from IVDR to ISO 13485 and MDSAP.

  • Audit-Ready, All Year Round

    Our structured audits, risk analyses, and transparent reports help you stay inspection-ready and avoid delays.

  • Global Access, One Partner

    CE, UKCA, FDA, and more – access key markets through one global provider, saving time and reducing complexity.

  • 40+ Years of IVD Expertise

    Work with experienced teams and specialized labs for high-risk, companion, and software-based diagnostics.

Certipedia – TÜV Rheinland Database for all Tested and Certified Products, Services and Organizations.