Legal Requirements for Medical Software

This article summarizes all important resources of legal requirements for medical software. Amongst others you will find always up to date links to laws, corresponding guidelines as well as harmonized standards for medical software.

Note that also the jurisdiction of Court of Justice of the European Union (CJEU) plays an important role in the interpretation of legal requirements. We have collected the top court cases on medical devices in a separate blog article.

New European Legal Requirements

European Laws

NumberTitleDate
C(2020) 2532M/565 Commission Implementing Decision C(2020) 2532 of 15.5.2020 on a standardisation request to the European Committee for Standardization and the European Committee for Electrotechnical Standardization as regards medical devices in support of Regulation (EU) 2017/745 of the European Parliament and of the Council and in vitro diagnostic medical devices in support of Regulation (EU) 2017/746 of the European Parliament and of the Council2020-05
2020/C 171/01Communication from the Commission Guidelines on the adoption of Union-wide derogations for medical devices in accordance with Article 59 of Regulation (EU) 2017/7452020-05
2020/561Regulation (EU) 2020/561 of the European Parliament and of the Council of 23 April 2020 amending Regulation (EU) 2017/745 on medical devices, as regards the dates of application of certain of its provisions2020-04
MDCG 2020Joint Implementation/preparedness plan on the new Medical Devices Regulation 2017/745 (MDR)2020-03
2017/745MDR (consolidated version with corrigenda 3.5.2019 and 27.12.2019)
Regulation (EU) 2017/745 on medical devices, amending directive 2001/83/EC, regulation (EC) No 178/2002 and regulation (EC) No 1223/2009 and repealing council directives 90/385/EEC and 93/42/EEC
2019-12
2017/746IVDR (consolidated version with corrigendum 3.5.2019)
Regulation (EU) 2017/746 on in vitro diagnostic medical devices and repealing directive 98/79/EC and commission decision 2010/227/EU
2019-05
207/2012Commission regulation (EU) on electronic instructions for use of medical devices2012-03
2019/939Commission implementing decision (EU) designating issuing entities designated to operate a system for the assignment of unique device identifiers (UDIs) in the field of medical devices 2019-06

MDCG Guidelines

Unique Device Identification (UDI)

NumberTitleDate
GS1 UDI HRI & AIDC FormatsAppendix A: UDI HRI Formats – GS1 Sample UDI labels2019-12
IA UDI HRI & AIDC FormatsAppendix A: UDI HRI Formats – IFA Standards2019-12
IFA Basic UDI-DIBasic UDI-DI – IFA Standards2019-12
ICCBBA Basic UDI-DICoding and Labeling of Medical Devices Containing MPHO2019-12
HIBCC UI HRI & AIDC FormatsAppendix A: UDI HRI Formats HIBCC Standards2019-12
ICCBBA UDI HRI & AICD FormatsAppendix A: UDI HRI Formats – ICCBBA Standards2019-12
HIBCC Basic UDI-DIHIBCC Basic UDI-DI2019-12
GS1 Basic UDI-DIGeneral Specifications Change Notification (GSCN)2019-12
MDCG 2019-1 MDCG guiding principles for issuing entities rules on basic UDI-DI2019-01
MDCG
2019-2
Guidance on application of UDI rules to device-part of products referred to in article 1(8), 1(9) and 1(10) of regulation 745/2012019-02
MDCG
2018-1 v3
Guidance on BASIC UDI-DI and changes to UDI-DI 2020-03
MDCG
2018-2
Future EU medical device nomenclature description of requirements2018-03
MDCG
2018-3 Rev.1
Guidance on UDI for systems and procedure packs2020-06
MDCG
2018-4
Definitions/descriptions and formats of the UDI core elements for systems or procedure packs2018-10
MDCG
2018-5
UDI assignment to medical device software2018-10
MDCG
2018-6
Clarifications of UDI related responsibilities in relation to article 162018-10
MDCG
2018-7
Provisional considerations regarding language issues associated with the UDI database2018-10
UDIWG 2018-1 UDI database, definitions/descriptions and formats of the UDI core elements 2018-03
UDIWG 2018-2 The architecture of the UDI database – basic UDI-DI and UDI-DI attributes for medical devices and in vitro diagnostic medical devices 2018-03
Unique Device Identification (UDI) System under the EU Medical Device Regulations 2017/745 and 2017/746 – FAQs 2019-08

European Databank on Medical Devices (EUDAMED)

Number Title Date
The CND Nomenclature – background and general principles2020-01
The European Medical Device Nomenclature (EMDN) – the nomenclature of use in EUDAMED 2020-01
MDCG
2019-5
Registration of legacy devices in EUDAMED 2019-05
MDCG 2019-4 Timelines for registration of device data elements in EUDAMED 2019-04

Clinical Investigation and Evaluation, PMCF

Number TitleDate
MDCG 2020-13Clinical evaluation assessment report template2020-07
MDCG 2020-10/1Safety reporting in clinical investigations of medical devices under the Regulation (EU) 2017/7452020-05
MDCG 2020-8Post-market clinical follow-up (PMCF) Evaluation Report Template. A guide for manufacturers and notified bodies2020-04
MDCG 2020-7Post-market clinical follow-up (PMCF) Plan Template. A guide for manufacturers and notified bodies2020-04
MDCG 2020-6Regulation (EU) 2017/745: Clinical evidence needed for medical devices previously CE marked under Directives 93/42/EEC or 90/385/EEC. A guide for manufacturers and notified bodies2020-04
MDCG 2020-5Clinical Evaluation – Equivalence. A guide for manufacturers and notified bodies2020-04
MDCG 2019-9 Summary of safety and clinical performance 2019-08

Other Topics

NumberTitleDate
MDCG 2020-9Regulatory requirements for ventilators and related accessories2020-04
MDCG 2020-2 rev.1Class I Transitional provisions under Article 120 (3 and 4) – (MDR) 2020-07
MDCG 2019-15 rev.1Guidance notes for manufacturers of class I medical devices2019-12
MDCG 2019-8 v2Implant Card relating to the application of Article 18 Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices2020-03
MDCG 2019-7 Guidance on Article 15 of the Medical Device Regulation (MDR) and in vitro Diagnostic Device Regulation (IVDR) regarding a “person responsible for regulatory compliance” (PRRC)2019-07
MDCG 2019-3 rev.1Interpretation of article 54 (2)b2020-04

Notified bodies

NumberTitleDate
MDCG 2020-14Guidance for notified bodies on the use of MDSAP audit reports in the context of surveillance audits carried out under the Medical Devices Regulation (MDR)/In Vitro Diagnostic medical devices Regulation (IVDR)2020-08
MDCG 2020-12Guidance on transitional provisions for consultations of authorities on devices incorporating a substance which may be considered a medicinal product and which has action ancillary to that of the device, as well as on devices manufactured using TSE susceptible animal tissues2020-06
MDCG 2020-11Guidance on the renewal of designation and monitoring of notified bodies under Directives 90/385/EEC and 93/42/EEC to be performed in accordance with Commission Implementing Regulation (EU) 2020/666 amending Commission Implementing Regulation (EU) 920/20132020-05
MDCG 2020-04Guidance on temporary extraordinary measures related to medical device Notified Body audits during COVID-19 quarantine orders and travel restrictions2020-04
MDCG 2020-03Guidance on significant changes regarding the transitional provision under Article 120 of the MDR with regard to devices covered by certificates according to MDD or AIMDD2020-03
MDCG 2020-01Guidance on Clinical Evaluation (MDR)/ Performance Evaluation (IVDR) of Medical Device Software2020-03
MDCG 2019-16Guidance on Cybersecurity for medical devices2020-01
MDCG 2019-14Explanatory note on MDR codes2019-12
MDCG 2019-13Guidance on sampling of MDR Class IIa / Class IIb and IVDR Class B / Class C devices for the assessment of the technical documentation2019-12
MDCG 2019-12Designating authority’s final assessment form: Key information (EN)2019-10
MDCG 2019-11Guidance on Qualification and Classification of Software in Regulation (EU) 2017/745 – MDR and Regulation (EU) 2017/746 – IVDR2019-10
MDCG 2019-10 rev.1Application of transitional provisions concerning validity of certificates issued in accordance to Directives2019-10
MDCG 2019-6 v2Questions and answers: Requirements relating to notified bodies2019-10
MDCG 2018-8Guidance on content of the certificates, voluntary certificate transfers2018-11

Other Resources

NumberTitleRemarks
NANDO List of MDR Notified Bodies
Blue GuideThe ‘Blue Guide’ on the implementation of EU products rules 2016
Leitfaden für die Umsetzung der Produktvorschriften der EU 2016
2016
IECEENational Certification Body VDE Prüf- und Zertifizierungsinstitut GmbH

Current European Legal Requirements

European Laws

NumberTitleDate
2020/437Commission Implementing Decision (EU) 2020/437 of 24 March 2020 on the harmonised standards for medical devices drafted in support of Council Directive 93/42/EEC2020-03
MDD Council Directive 93/42/EEC on Medical Devices 1993
AIMDDCouncil Directive 90/385/EEC on Active Implantable Medical Devices 1990
IVDMD Council Directive 98/79/EC on In Vitro Diagnostic Medical Devices 1998
2017/C 389/03 Commission communication in the framework of the implementation of the Council Directive 93/42/EEC of 14 June 1993 concerning medical devices – OJ C 389 of 17/11/2017 (harmonized standards list)2017

Manuals

NumberTitleDate
Manual V1.22 Manual on borderline and classification in the community regulatory framework for medical devices2019-05

MEDDEV Guidelines

NumberTitle Date
2.1/1Definitions of “medical devices”, “accessory” and “manufacturer” 1994-04
2.12/1 rev. 8Guidelines on a medical device vigilance system 2013-01
2.12/1 rev. 8 Additional Guidance Regarding the Vigilance System as outlined in MEDDEV 2.12-1 rev. 8 2019-07
2.1/6Qualification and classification of stand alone software2016-07
2.7/1
rev.
4.
Clinical evaluation: Guide for manufacturers and notified bodies 2016-06
2.7/1
App
1
Appendix 1: Clinical evaluation on coronary stents 2008-12
2.7/2 rev. 2Guide for competent authorities for making a validation/ assessment of a clinical investigation application2015-09
2.7/3 rev. 3 Clinical investigations: Serious adverse event reporting 2015-05
2.7/3 SAE reporting form 2015-05
2.7/4Guidelines on clinical investigations: A guide for manufacturers and notified bodies 2010-12

EU Standards

(Links lead to German versions of EU Standards)

NumberTitle Date
EN ISO 14971Anwendung des Risikomanagements auf Medizinprodukte 2012
EN ISO 13485Qualitätsmanagementsysteme – Anforderungen für regulatorische Zwecke 2016
EN 62304Medizingeräte-Software
Software-Lebenszyklus-Prozesse
2006 + Cor.:2008 + A1:2015
EN 62366-1Medizinprodukte
Teil 1: Anwendung der Gebrauchstauglichkeit auf Medizinprodukte
2015 + AC:2015
EN ISO 14155Klinische Prüfung von Medizinprodukten an Menschen – Gute klinische Praxis 2011 + AC:2011
EN 60601-1Medizinische elektrische Geräte
Teil 1: Allgemeine Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale
2006 + Cor.:2010 + A1:2013
EN 82304-1Gesundheitssoftware
Teil 1: Allgemeine Anforderungen für die Produktsicherheit
2017

International Guidelines

IMDRF – International Medical Device Regulators Forum

Number Title Date
N60 FINAL:2020Principles and Practices for Medical Device Cybersecurity2020-03
N52 FINAL:2019 Principles of labelling for medical devices and IVD medical devices 2019-03
N48 FINAL:2019 Unique device identification system (UDI system) application guide 2019-03
N9
FINAL:2019 (Edition 3)
Non-In Vitro diagnostic device market authorization table of contents (nIVD MA ToC) 2019-03
IMDRF/AE WG/N43FINAL:2020 (Edition 4)Terminologies for categorized adverse event reporting (AER): Terms, terminology and codes

Annex A: IMDRF terminologies for categorized adverse event reporting (AER): terms, terminology structure and codes

Annex B: IMDRF terminologies for categorized adverse event reporting (AER): type of investigation

Annex C: IMDRF terminologies for categorized adverse event reporting (AER): Investigation findings

Annex D: IMDRF terminologies for categorized adverse event reporting (AER): Investigation Conclusion

Annex E: IMDRF terminologies for categorized adverse event reporting (AER): Clinical signs and symptoms or conditions

Annex F: IMDRF terminologies for categorized adverse event reporting (AER): Health impact

Annex G: IMDRF terminologies for categorzed adverse event reporting (AER): Medical device component
2020-07
N27 FINAL:2019 Assembly and technical guide for IMDRF table of contens submissions

IVD Template

nIVD Template
2018-11
N51 FINAL:2018 Optimizing standards for regulatory use 2018-11
N47 FINAL:2018 Essential principles of safety and performance of medical devices and IVD medical devices 2018-10
N46 FINAL:2018 Tools for assessing the usability of registries in support of regulatory decision-making 2018-03
N14
FINAL:2017 (Edition 2)
Medical devices: Post-market surveillance: National competent authority report exchange criteria and report form 2017-09
N41 FINAL:2017 Software as a medical device (SaMD): Clinical evaluation 2017-09
N19 FINAL:2016 Common data elements for medical device identification 2016-03
N24 FINAL:2015 Medical device regulatory audit reports 2015-10
N23 FINAL:201 Software as a medical device (SaMD): Application of quality management system 2015-10
N12 FINAL:2014 Software as a medical device: Possible framework for risk categorization and corresponding considerations 2014-09
N7 FINAL:2013 UDI guidance: Unique device identification (UCI) of medical devices 2013-12
N10 FINAL:2013 Software as a medical device (SaMD): Key definitions 2013-12
SG1-N78 Principles of conformity assessment for medical devices (revision of GHTF/SG1/N40:2006)2012-11
SG1-N77 Principles of medical devices classification (revision of GHTF/SG1/N15:2006) 2012-11
SG1-N68 Essential principles of safety and performance of medical devices (revision of
GHTF/SG1/N41:2005)
2012-11
SG1-N071 Definition of the terms ‘medical device’ and ‘in vitro diagnostic (IVD) medical device’ 2012-05
SG1-N70 Label and instructions for use for medical devices 2011-09
SG1-N063 Summary technical documemtation (STED) for demonstrating conformity to the essential principles of safety and performance of in vitro diagnostic medical devices 2011-03
SG1-N055 Definition of the terms manufacturer, authorised representative, distributor and importer2009-03
SG1-N044Role of standards in the assessment of medical devices2008-03
SG1-N011Summary technical documentation for demonstrating conformity to essential principles of safety and performance of medical devices (STED)2008-02

U.S. Food and Drug Administration (FDA) Guidances

NumberTitleDate
510(k) Third Party Review Program 2020-03
Clinical Decision Support Software2019-09
Policy for Device Software Functions and Mobile Medical Applications2019-09
Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act2019-09
Consideration of Uncertainty in Making Benefit-Risk Determinations in Medical Device Premarket Approvals, De Novo Classifications, and Humanitarian Device Exemptions2019-08
Proposed Regulatory Framework for Modifications to Artificial Intelligence/Machine Learning (AI/ML)- Based Software as a Medical Device (SaMD)2019-05
Developing Software Precertification Program: A Working Model, v1.0.2018-06
IMDRF/SaMD WG/N41FINAL:2017Software as a Medical Device (SAMD): Clinical Evaluation 2017-12
Postmarket Management of Cybersecurity in Medical Devices 2016-12
Non-Inferiority Clinical Trials to Establish Effectiveness2016-11
Principles for Codevelopment of an In Vitro Companion Diagnostic Device with a Therapeutic Prouct2016-07
Content of Premarket Submissions for Management of Cybersecurity in Medical Devices 2014-10
In Vitro Diagnostic Multivariate Index Assays2007-07
Statistical Guidance on Reporting Results from Studies Evaluating Diagnostic Tests2007-03
Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices 2005-05
Cybersecurity for Networked Medical Devices Containing Off-the-Shelf (OTS) Software2005-01

German Legal Requirements

German Laws and Subordinate Ordinances

Abbr.TitelDate
MPDGDeutsches Medizinprodukte-informations- und Datenbanksystem2020-05
DiGAVVerordnung über das Verfahren und die Anforderungen der Prüfung der Erstattungsfähigkeit digitaler Gesundheitsanwendungen in der gesetzlichen Krankenversicherung (Digitale-Gesundheitsanwendungen-Verordnung – DiGAV)2020-04
DVGEntwurf eines Gesetzes für eine bessere Versorgung durch Digitalisierung und Innovation (Digitale-Versorgung-Gesetz – DVG)2019-09
MPAnpG-EU Draft Law MPAnpG-EU to Adapt the Medical Devices Legislation in Germany to MDR and IVDR

Entwurf eines Gesetzes zur Anpassung des Medizinprodukterechts an die Verordnung (EU) 2017/745 und die Verordnung (EU) 2017/746
2019-08
MPGGerman Medical Devices Act

Gesetz über Medizinprodukte (Medizinproduktegesetz – MPG)
2017-07
HWGAct on Advertising in the Field of Health

Gesetz über die Werbung auf dem Gebiete des Heilwesens (Heilmittelwerbegesetz – HWG)
2016-09
MPVOrdinance on Medical Devices

Verordnung über Medizinprodukte (Medizinprodukte-Verordnung – MPV)
2016-09
MPSVOrdinance on the recording, evaluation and prevention of risks relating to medical devices

Verordnung über die Erfassung, Bewertung und Abwehr von Risiken bei Medizinprodukten (Medizinprodukte-Sicherheitsplanverordnung – MPSV)
2018-11
MPBetreibVOrdinance on the Installation, Operation and Use of Medical Devices

Verordnung über das Errichten, Betreiben und Anwenden von Medizinprodukten (MPBetreibV)
2018-11
MPAVOrdinance on the Supply of Medical Devices

Verordnung zur Regelung der Abgabe von Medizinprodukten (Medizinprodukte-Abgabeverordnung – MPAV)
2018-09
BKost-MPGFees Ordinance Relating to the Medical Devices Act (MDA) and the statutory instruments for its implementation (MDA Fees Ordinance)

Gebührenverordnung zum Medizinproduktegesetz und den zu seiner Ausführung ergangenen Rechtsverordnungen (Medizinprodukte-Gebührenverordnung – BKostV-MPG)
2016-07
MPKPVOrdinance on Clinical Investigations with Medical Devices

Verordnung über klinische Prüfungen von Medizinprodukten (MPKPV)
2014-07

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