European Union

EU In Vitro Diagnostic Medical Devices Regulation (IVDR)

26 controls. 4 other frameworks in our corpus share controls with it. Here is all of it, and how much of it you are already doing.

Page built . This page is derived from the framework corpus, which changes when the corpus is extended rather than daily.

26 controls 4 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 IVDR In Vitro Diagnostic 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 runShared controls
EU Medical Devices Regulation (MDR 2017/745)11measure it →
FDA Quality Management System Regulation (QMSR)3measure it →
GDPR3measure it →
EU Clinical Trials Regulation (CTR 536/2014)3measure it →

Every control

CodeControlAlso in
IVDR-Art.10General obligations of manufacturers (Article 10)2
IVDR-Art.102_103_104Confidentiality, data protection and Medical Device Coordination Group cooperation (Articles 102-104)1
IVDR-Art.110Transitional provisions (Article 110 as amended by (EU) 2024/1860)1
IVDR-Art.112_113Penalties and entry into force (Articles 112-113)0
IVDR-Art.11_12Authorised representative and change of authorised representative (Articles 11-12)0
IVDR-Art.13_14Obligations of importers and distributors (Articles 13-14)0
IVDR-Art.15Person Responsible for Regulatory Compliance (Article 15)1
IVDR-Art.16Cases in which obligations of manufacturers apply to others (Article 16)0
IVDR-Art.17_18EU declaration of conformity and CE marking (Articles 17-18)1
IVDR-Art.1_2_3Subject matter, definitions and regulatory status (Articles 1-3)0
IVDR-Art.22_23_24_25Identification within supply chain + UDI system (Articles 22-25)1
IVDR-Art.26_27_28Registration of devices and economic operators (Articles 26-28)1
IVDR-Art.29_30Summary of safety and performance + European database (Articles 29-30)1
IVDR-Art.31_32_33Notified bodies - authorities, requirements and subsidiaries (Articles 31-33)0
IVDR-Art.4Genetic information, counselling and informed consent for genetic tests (Article 4)2
IVDR-Art.47Classification of devices (Article 47 and Annex VIII)0
IVDR-Art.48_49_50Conformity assessment procedures + NB involvement + Class D scrutiny (Articles 48-50)0
IVDR-Art.51_52_53_54_55Certificates of conformity, electronic system, voluntary change of NB, derogations, certificates of free sale (Articles 51-55)0
IVDR-Art.56_57_58Performance evaluation, performance studies and additional requirements (Articles 56-58)3
IVDR-Art.59_60_61_62Informed consent + protection of subjects + emergency situations (Articles 59-62)2
IVDR-Art.5_6_7Placing on the market, distance sales and claims (Articles 5-7)0
IVDR-Art.78Post-market surveillance plan and system (Article 78)2
IVDR-Art.80_81Periodic Safety Update Report (Article 80 + 81)1
IVDR-Art.82_83_84_85_86Vigilance + serious incident reporting + field safety corrective actions (Articles 82-86)1
IVDR-Art.8_9Harmonised standards and common specifications (Articles 8-9)0
IVDR-Art.92_93_94_95Market surveillance and Member-State competent authorities (Articles 92-95)0

Tell me when EU In Vitro Diagnostic Medical Devices Regulation (IVDR) 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.

  • 10-year supplier / customer records by device
  • UDI assignment + database submission per Article 24
  • Nomenclature alignment in Article 25 records
  • Substantial-modification policy aligned with Article 17
  • Own-brand review process
  • 10-year supplier / customer records
  • 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

How programmes fail on this

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

What this page is

A control-level reference for EU In Vitro Diagnostic Medical Devices Regulation (IVDR), 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.

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