EU MDR — Regulation (EU) 2017/745

The European Union's Medical Devices Regulation. Covers economic-operator obligations, classification, GSPRs, clinical evaluation and PMCF, post-market surveillance, vigilance, UDI and EUDAMED.

Modules

20 modules

Category

Regulatory

Pass mark

80%

Certificate

Free, instant

Audience

Regulatory affairs, clinical, post-market and quality teams placing devices on the EU market.

• Understand overview of the EU MDR
• Understand classification and General Safety & Performance Requirements
• Understand clinical Evaluation, Investigation and PMCF
• Understand post-Market Surveillance, Vigilance and Traceability
• Understand technical Documentation (Annex II and III)
• Understand software as a Medical Device and Cybersecurity
• Understand labelling, IFU, UDI and Implant Card
• Understand eUDAMED, Actor Registration and SRN

• Navigate global regulations

  Decode regional regulatory frameworks and learn what authorities expect from manufacturers.

• Stay audit-ready

  Understand the exact clauses and expectations auditors and regulators check during inspections.

• Boost your career

  A recognised certificate of completion that you can add to your CV and LinkedIn profile.

• Plain-language modules

  Complex requirements broken into bite-sized, easy-to-remember lessons with examples.

• Free assessment & certificate

  Take the timed exam and earn a personalised, verifiable certificate at no cost.

• Regulatory affairs, clinical, post-market and quality teams placing devices on the EU market

• 20 plain-language modules

  Bite-sized lessons with examples, memory aids and key terms.

• Timed assessment

  Multiple-choice exam with 80% pass mark. Retake anytime.

• Verifiable certificate

  Personalised PDF with a unique verification code — shareable on LinkedIn.

• Downloadable resources

  Reference material and attachments available inside modules.

• Lifetime access

  Learn at your own pace — revisit modules whenever you need to refresh.

• Aligned to standards

  Content mapped to internationally recognised medical device standards and regulations.

More questions? Visit the full FAQ.