Medical Device Regulation Test (EU MDR & FDA)

The Medical Device Regulation Test (EU MDR & FDA) is a free advanced-level, 25-minute skill test from Science of Apps. A medical device regulatory affairs skills test covering EU MDR classification and conformity assessment, clinical evaluation and post-market surveillance, FDA premarket pathways and reporting, quality and risk management (ISO 13485, the FDA QMSR and ISO 14971), and software, AI, UDI and labelling — written to Regulation (EU) 2017/745, 21 CFR, ISO standards and FDA guidance as they apply in 2026. Educational only; not legal or regulatory advice. Score 70% or more on its 25 questions to earn a verifiable Medical Device Regulation certificate (SOA-MD). Every question is based on published standards and research — including Regulation (EU) 2017/745 on medical devices (MDR) (European Union), Premarket submissions: selecting and preparing the correct submission (US Food and Drug Administration), ISO 14971:2019 Medical devices — Application of risk management to medical devices (ISO) — and each answer is explained with its source.

Take the free Medical Device Regulation Test on Science of Apps. It tests device classification, technical documentation, and QMSR against a 2026–2027 syllabus, and passing earns a verifiable certificate you can add to LinkedIn.

Read the five skill areas on this page, then take the 25-minute test online — no fee, course or sign-up. You see every answer explained when you finish. Score 70% or more and you get a Medical Device Regulation certificate straight away, on screen, as a PDF and by email, with a credential ID anyone can verify.

Yes. The questions are original scenarios written by Science of Apps, and each one is based on a public source you can read: Regulation (EU) 2017/745 on medical devices (MDR) (European Union); Premarket submissions: selecting and preparing the correct submission (US Food and Drug Administration); ISO 14971:2019 Medical devices — Application of risk management to medical devices (ISO); ISO 13485:2016 Medical devices — Quality management systems (ISO); Quality Management System Regulation (21 CFR 820, aligned with ISO 13485) (US Food and Drug Administration); Artificial Intelligence-Enabled Medical Devices (US Food and Drug Administration). The source is shown under each question and linked in the answer review. Science of Apps doesn't copy questions from other tests.

Five skill areas with five questions each, drawn from a bank of 10 per area so a retake brings new questions: EU MDR Classification and Conformity (Classes, Rules and Notified bodies); Clinical Evaluation and Post-Market Surveillance (Clinical evidence, PMS and Vigilance); FDA Pathways and Reporting (510(k), De Novo, PMA and MDR reporting); Quality and Risk Management (ISO 13485, QMSR and ISO 14971); Software, AI, UDI and Labelling (SaMD, IEC 62304, UDI and Cybersecurity). Every question is an original scenario written to the 2026–2027 standard, with the published source named under it.

Regulatory affairs specialist, Quality assurance engineer, Clinical affairs manager, Post-market surveillance specialist and Medical device product manager. It suits anyone who wants a quick, verifiable way to show Medical Device Regulation knowledge in 2026 and 2027, from students and career switchers to experienced professionals.

The EU MDR uses risk classes I to III with notified bodies assessing conformity for CE marking, while the FDA uses classes I to III with pathways such as 510(k), De Novo and PMA reviewed by the FDA itself. Both require a quality system, clinical evidence and post-market surveillance.

The FDA's Quality Management System Regulation (QMSR) took effect on 2 February 2026, amending 21 CFR 820 to incorporate ISO 13485:2016 by reference and replacing the old Quality System Regulation.

Yes. The test is online, in English and free everywhere — people take it from India, the US, the UK, Europe, Africa, Latin America and Asia-Pacific. Your certificate is dated with your own local date and can be verified from anywhere at scienceofapps.com/certification/verify/.

25 questions — 5 from each of 5 skill areas — with a 25-minute limit. You need 70% (18 of 25) to pass and 90% for distinction.

We rate it Advanced: assumes years in the role or deep specialist knowledge. It has 25 scenario questions — 5 from each of 5 skill areas — and a 25-minute limit. You need 70% (18 of 25) to pass and 90% for distinction.

Nothing. There is no fee to take a test, to receive the certificate, to have it emailed or to verify it, and no sign-up.

On our server, not in your browser. The answers never reach the page until you submit, so a certificate can only be earned by passing. Each certificate gets a unique credential ID stored by Science of Apps.

You see your score for each area and every question with the correct answer and why, with the published source behind it. You can retake after 30 minutes, and the retake draws questions you haven't seen yet.

No. Every certificate is dated, so it always shows when you passed. Retake a test any time for a newer date or a higher score.

Yes. After you pass, Add to LinkedIn opens the Licenses & certifications form with the certificate name, Science of Apps as the issuer, the issue date, your credential ID and the verification link filled in. You can also download it as a PDF or PNG, and it's emailed to you as a PDF.

Every certificate has a credential ID and a QR code. Scanning it, or entering the ID at scienceofapps.com/certification/verify/, shows the holder's name, the certification, the score and the issue date from our records.

No. They are Science of Apps' own assessments of applied skill. They aren't issued by a university or standards body, and they work best alongside a portfolio that shows the skills in real work.