UK Medicines and Medical Devices Act 2021

Regulates the safety and supply of medicines and medical devices in the UK post-Brexit.

12

Rules extracted

185

Obligations decomposed

15.4x

Avg obligations per rule

🇬🇧 United Kingdom

Jurisdiction

About this regulation

The Medicines and Medical Devices Act 2021 provides the UK Government with powers to update and amend the regulatory frameworks for human medicines, veterinary medicines and medical devices following the UK's departure from the European Union. It establishes a Patient Safety Commissioner, consolidates enforcement powers for medical devices, introduces civil sanctions, and enables the creation of a UK medical device information system. The Act is administered by the Medicines and Healthcare products Regulatory Agency (MHRA).

What AuditDSS covers

Source

1

Regulation

Extracted

12

Rules

Decomposed

185

Obligations

15.4x

Decomposition ratio

Each rule is decomposed into an average of 15.4 atomic obligations — the smallest testable units that can be independently violated.

Fully extracted & scored

All 185 obligations have been decomposed, titled, risk-scored, and embedded for semantic matching.

Risk scoring

Every obligation in MMDA 2021 is scored across independent risk dimensions:

W

Obligation Weight

How critical within the regulatory framework

L

Violation Likelihood

How often breached in practice

E

Enforcement Evidence

Regulator enforcement history and penalties

C

Cascade Dependency

How many obligations depend on this one

Regulatory details

Full title
UK Medicines and Medical Devices Act 2021
Regulatory body
Medicines and Healthcare products Regulatory Agency
Jurisdiction
🇬🇧 United Kingdom
Document type
act
Effective date
February 11, 2021
Issuing authority
Parliament of the United Kingdom
Official source
View source document ↗

Who this applies to

marketing authorisation holdersmanufacturerswholesale dealersapproved bodiesUK responsible personsclinical trial sponsorsveterinary surgeons

Key requirements

  • UKCA marking for medical devices
  • marketing authorisation for medicines
  • clinical trial authorisation
  • approved body designation
  • vigilance and post-market surveillance
  • unique device identification
  • patient safety commissioner

Frequently asked questions about MMDA 2021

What is MMDA 2021?

The Medicines and Medical Devices Act 2021 provides the UK Government with powers to update and amend the regulatory frameworks for human medicines, veterinary medicines and medical devices following the UK's departure from the European Union. It establishes a Patient Safety Commissioner, consolidates enforcement powers for medical devices, introduces civil sanctions, and enables the creation of a UK medical device information system. The Act is administered by the Medicines and Healthcare products Regulatory Agency (MHRA).

Who does MMDA 2021 apply to?

MMDA 2021 applies to marketing authorisation holders, manufacturers, wholesale dealers, approved bodies, UK responsible persons, clinical trial sponsors, veterinary surgeons.

How many obligations does MMDA 2021 contain?

AuditDSS has decomposed MMDA 2021 into 185 atomic obligations from 12 rules. Each obligation is independently testable and risk-scored.

What are the key requirements of MMDA 2021?

The key requirements include: UKCA marking for medical devices, marketing authorisation for medicines, clinical trial authorisation, approved body designation, vigilance and post-market surveillance, unique device identification, patient safety commissioner.

How can I assess my MMDA 2021 compliance?

Upload your compliance policy to AuditDSS. The platform maps your document against all 185 MMDA 2021 obligations using deterministic AI scoring — not checklists or LLM summaries. You get a risk-scored gap analysis showing exactly which obligations are covered, partially covered, or missing.

Which jurisdiction enforces MMDA 2021?

MMDA 2021 is enforced in United Kingdom by Medicines and Healthcare products Regulatory Agency.

When did MMDA 2021 come into effect?

MMDA 2021 became effective on February 11, 2021.

What industry does MMDA 2021 apply to?

MMDA 2021 is primarily relevant to the Medical Devices & Diagnostics industry. AuditDSS covers 64 regulations in this industry sector.

Build a MMDA 2021 compliance pack

Don't have a compliance policy yet? AuditDSS generates a complete compliance pack for MMDA 2021 — alone or combined with other regulations your business needs. Every clause is mapped to specific obligations.

Policy

High-level commitments and governance framework covering MMDA 2021 requirements.

Procedures

Step-by-step operational procedures to implement each policy commitment.

Forms & checklists

Ready-to-use forms, registers, and checklists for day-to-day compliance operations.

Multi-regulation

Combine MMDA 2021 with other regulations into a single unified compliance pack for your business.

Already have a policy? Assess it against MMDA 2021

1

Upload your document

Upload your compliance policy, program manual, or operational document. AuditDSS accepts any text-based document.

2

AI maps against 185 obligations

Your document is scored against every obligation in MMDA 2021. Each claim is mapped to the obligation tree and evaluated for coverage.

3

Risk-scored gap report

Receive every gap ranked by risk priority with remediation guidance, enforcement evidence, and cascade impact analysis.

Related regulations in Medical Devices & Diagnostics

Assess your MMDA 2021 compliance

Upload your document and get a risk-scored gap analysis against 185 MMDA 2021 obligations in under 5 minutes.