AI in medical devices · Basic · 13 min lesson

Regulatory landscape for AI medical devices across the EU, US, UK and Israel

MDR 2017/745, AI Act (EU) 2024/1689 Articles 6 and 43, MDCG 2025-6, FD&C Act section 515C, MHRA roadmap, Israel AMAR registration

What you will learn

Explain how the EU MDR and the AI Act apply together to an AI device and give the key dates.
Compare the US pathways, predetermined change control plans and the UK and Israeli routes at a high level.
Build a market-by-market regulatory strategy record and spot the gaps an auditor would find.

In the EU the MDR sets the class (Rule 11) and the AI Act decides high-risk status (Article 6(1)), assessed together under Article 43.
AI Act dates: in force 1 August 2024; device high-risk rules move to 2 August 2028 after the digital omnibus; always confirm in the Official Journal.
US: 510(k), De Novo or PMA by risk; a PCCP under section 515C can pre-agree model changes; CDS exclusion excludes signal analysis.
UK relies on the 2002 regulations plus the MHRA change programme; Israel registers via AMAR building on trusted foreign approvals.
A regulatory strategy record per market links route, class, dates, dependencies and change plan (ISO 13485 clause 7.2.1).

Halcyon's Pulse Guard is MDR class IIa and requires a notified body. A colleague says the AI Act is only for social media companies.

What does the AI Act require the team to consider?

Nothing, because medical devices are outside the AI Act.

Not quite. Medical devices fall under Annex I of the AI Act, so Article 6(1) can make their AI high-risk.

That the AI is high-risk under Article 6(1) with Annex I, so Articles 9 to 15 must be met within the MDR assessment.

Correct. Article 6(1) links high-risk status to products needing notified body assessment, and Article 43 allows one combined procedure.

Only the prohibited practices of Article 5.

Not quite. Article 5 lists prohibited practices; high-risk obligations in Articles 9 to 15 are the relevant ones for a class IIa device.

Only the labelling language of each country.

Not quite. Language rules are separate; the AI Act in Article 6(1) concerns risk management, data and oversight.

AI Act: Regulation (EU) 2024/1689 on artificial intelligence, which classes AI in regulated products as high-risk when a notified body is required (Article 6(1)).
notified body: An organisation designated by an EU authority to assess conformity of devices that need third-party assessment.
PCCP: A plan agreed with FDA that describes future modifications and how they will be validated, under FD&C Act section 515C.
510(k): US premarket notification showing substantial equivalence to a legally marketed predicate device.
De Novo: US route to classify a new low to moderate risk device type that has no predicate.
AMAR: The Medical Equipment Division of the Israeli Ministry of Health, which registers medical devices.
MDCG 2025-6: June 2025 European Commission FAQ on how the MDR and IVDR interact with the AI Act.
digital omnibus: EU legislative package that postponed the AI Act high-risk application dates; confirm status in the Official Journal.

The full lesson has narrated slides, more scenario questions with explained answers and a simulation.

Illustrative example. Educational only, not legal advice.