AI Act and AI-Enabled Medical Devices - Current Regulatory Status

Current Certification Pathway: MDR/IVDR Remains Primary Route

As of March 2026, AI-enabled medical devices continue to be certified exclusively under the MDR/IVDR framework. The AI Act's high-risk obligations for medical devices classified under Article 6(1) and Annex I are not yet applicable.

This means that:

1. MDR certification remains the sole regulatory pathway for placing AI-enabled medical devices on the EU market

2. No separate AI Act conformity assessment is currently required

3. Existing CE-marked MDAI products remain fully compliant under current regulations

Original AI Act Timeline for high-risk AI systems was structured as follows:

-          2 August 2026: Application date for high-risk AI systems under Annex III (use case-based classification)

-          2 August 2027: Application date for high-risk AI systems under Article 6(1) and Annex I, including AI-enabled medical devices.

However, these deadlines are widely expected to be postponed through the proposed "Digital Omnibus on AI" legislative package announced by the European Commission on 19 November 2025.

The delay reflects well-recognised implementation challenges, including:

-          Slow progress in designating national competent authorities and notifying AI Act-specific Notified Bodies

-          Delayed development of harmonized standards by CEN-CENELEC Joint Technical Committee 21 (JTC 21), with full standards not expected before December 2026

-          Absence of common specifications and Commission guidance necessary to support provider compliance

Key Implications for MDAI Manufacturers — Immediate Actions (March 2026):

1. Continue MDR/IVDR certification as normal – no AI Act-specific conformity assessment is currently required

2. Monitor Digital Omnibus legislative progress through Council and Parliament negotiations (expected adoption: late 2026)

3. Conduct gap analysis comparing current MDR/IVDR compliance against AI Act requirements, especially in regard to Technical Documentation & QMS.

4. Engage with Notified Bodies to understand their AI Act designation plans and expectations

Near-Term Preparations:

1.       Future-proof development processes by incorporating AI Act requirements into ongoing MDAI projects:

a.       Data governance frameworks per Article 10 (training, validation, test dataset quality)

b.       Bias examination and mitigation procedures

c.       Enhanced record-keeping and logging (Article 12)

d.       Transparency and human oversight mechanisms (Articles 13 and 14)

2.       Build competencies in AI literacy and governance across quality, regulatory, and development teams (Article 4)

Monitor harmonized standards development by CEN-CENELEC JTC 21, particularly EN 18286 (AI Quality Management System, first harmonized standard entering public enquiry October 2025)