EU Medical Devices Regulation (MDR 2017/745): every control, and what you already have

26 controls 5 frameworks share controls with it European Union verified against its source document

Every control below is one this framework asks for. The right hand column counts how many other frameworks in our corpus carry the same control, which is the difference between doing this work once and doing it again for the next standard.

EU MDR Medical Devices Regulation Evidence & Implementation Kit

26 controls is the documentation set somebody has to write. This is that set, already written: an adopt-ready artifact for every control in policy and procedure text you edit rather than draft, and the evidence checklist an auditor asks for against each.

See what is in it, $249

The same set every buyer of this kit receives. Nothing here is produced on request.

What you already have

Frameworks whose controls overlap this one, most first. If you run any of them, the count is roughly what you have already evidenced.

If you run	Shared controls
EU In Vitro Diagnostic Medical Devices Regulation (IVDR)	11	measure it →
FDA Quality Management System Regulation (QMSR)	3	measure it →
GDPR	2	measure it →
EU Clinical Trials Regulation (CTR 536/2014)	2	measure it →
EU Cyber Resilience Act	1	measure it →

Every control

Code	Control	Also in
`MDR-Art.10`	General obligations of manufacturers (Article 10)	2
`MDR-Art.103_104_105_106_107_108`	Medical Device Coordination Group + EU expert panels + EU reference laboratories (Articles 103-108)	0
`MDR-Art.109_110_111_112_113_115`	Confidentiality, data protection, funding, civil liability and penalties (Articles 109-115)	1
`MDR-Art.11_12_13_14`	Authorised representative, importers and distributors (Articles 11-14)	0
`MDR-Art.120`	Transitional provisions (Article 120 as amended by (EU) 2023/607)	2
`MDR-Art.122_123`	Entry into force and date of application (Articles 122-123)	0
`MDR-Art.15`	Person Responsible for Regulatory Compliance (Article 15)	1
`MDR-Art.16`	Cases where manufacturer obligations apply to others (Article 16)	0
`MDR-Art.17_18`	Single-use device reprocessing and implant card (Articles 17-18)	0
`MDR-Art.19_20`	EU declaration of conformity and CE marking (Articles 19-20)	1
`MDR-Art.1_2_3_4`	Subject matter, scope, definitions and regulatory status (Articles 1-4)	0
`MDR-Art.21_22_23`	Special purposes, systems and procedure packs, parts and components (Articles 21-23)	0
`MDR-Art.25_27_28`	Supply-chain identification and UDI system (Articles 25, 27-28)	1
`MDR-Art.29_30_31`	Registration of devices and economic operators (Articles 29-31)	1
`MDR-Art.32_33`	Summary of Safety and Clinical Performance + EUDAMED (Articles 32-33)	1
`MDR-Art.35_36_37_38_39_40_41_42_45_46_47_50`	Notified bodies - authorities, requirements, subsidiaries, designations and re-assessment (Articles 35-50 selected)	0
`MDR-Art.51`	Classification of devices (Article 51 and Annex VIII)	0
`MDR-Art.52_54_55`	Conformity assessment, consultation procedure and scrutiny mechanism (Articles 52, 54, 55)	0
`MDR-Art.56_57`	Certificates of conformity and electronic system (Articles 56-57)	0
`MDR-Art.5_6_7`	Placing on market + distance sales + misleading claims (Articles 5-7)	0
`MDR-Art.61_62`	Clinical evaluation and clinical investigations general requirements (Articles 61-62)	4
`MDR-Art.70_74_75_80_82`	Clinical-investigation application + CE-marked-device studies + substantial modifications + adverse events + records (Articles 70, 74-75, 80, 82)	1
`MDR-Art.83`	Post-market surveillance system of the manufacturer (Article 83)	2
`MDR-Art.84_85_86`	PMS plan + PMS report + Periodic Safety Update Report (Articles 84-86)	1
`MDR-Art.87_88_89_90_91_92`	Vigilance + serious incident reporting + FSCAs + trend reporting (Articles 87-92)	1
`MDR-Art.93_94_95_96_97_98`	Market surveillance + Member-State competent authorities (Articles 93-98)	0

Tell me when EU Medical Devices Regulation (MDR 2017/745) files something new

One email when a public company newly discloses something this framework governs, naming the company and what our corpus says it puts in scope. Nothing else, and one click to stop.

What an auditor will ask you to produce

The artefacts named on the failure modes this framework speaks to.

Corrective-action / withdrawal / recall procedure
Inspection-readiness records (tech doc + QMS + PMS file + vigilance file ready)
Inspection-readiness records (TMF inventory, audit trails, training records, monitoring plan execution)
Corrective-action records following any Member State inspection finding
Inspection-readiness records (technical documentation + QMS + PMS file + vigilance file ready)

How programmes fail on this

Failure modes named by this framework and others. Each opens the full record.

CAPA backlog from prior inspections named by 3 frameworks

What this page is

A control-level reference for EU Medical Devices Regulation (MDR 2017/745), drawn from our framework corpus. Control codes and titles are references to the standard, not reproductions of it. The overlap counts and the auditor artefacts are our own work and are the part you will not find elsewhere.

Measure this against what you already run · All frameworks · Today's edition