Person standing, having a a folder with a scale symbol on it, in his hands. In the background some shelves with many books on it. Altogether symbolizin a person taking care of the legal requirements and most importent documents for market access of medical software.

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
CORRIGENDUM to Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017
on medical devices
2019-11
2017/745MDR (consolidated version with corrigendum 3.5.2019)
Regulation (EU) 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

Verordnung (EU) über Medizinprodukte zur Änderung der Richtlinie 2001/83/EG, der Verordnung (EG) Nr. 178/2002 und der Verordnung (EG) Nr. 1223/2009 und zur Aufhebung der Richtlinien 90/385/EWG und 93/42/EWG des Rates
2017-05
2017/746IVDR (consolidated version with corrigendum 3.5.2019)
Regulation (EU) on in vitro diagnostic medical devices and repealing directive 98/79/EC and commission decision 2010/227/EU

Verordnung (EU) über In-vitro-Diagnostika und zur Aufhebung der Richtlinie 98/79/EG und des Beschlusses 2010/227/EU der Kommission
2017-05
207/2012Commission regulation (EU) on electronic instructions for use of medical devices

Verordnung (EU) über elektronische Gebrauchsanweisungen für Medizinprodukte
2012-03
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

Durchführungsbeschluss (EU) zur Benennung der Zuteilungsstellen, die für den Betrieb eines Systems zur Zuteilung von eindeutigen Produktidentifikationen im Bereich der Medizinprodukte benannt sind
2019-06
Draft standardisation request as regards medical devices in support of Regulation (EU) 2017/745 and in vitro diagnostic medical devices in support of Regulation (EU) 2017/746 2019-06

MDCG Guidelines

Unique Device Identification (UDI)

NumberTitleDate
MDCG 2019-1MDCG 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 v2
Draft guidance on BASIC UDI-DI and changes to UDI-DI2019-02
MDCG
2018-2
Future EU medical device nomenclature description of requirements2018-03
MDCG
2018-3
Guidance on UDI for systems and procedure packs2018-10
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
NumberTitleDate
UDIWG 2018-1UDI database, definitions/descriptions and formats of the UDI core elements2018-03
UDIWG 2018-2The architecture of the UDI database – basic UDI-DI and UDI-DI attributes for medical devices and in vitro diagnostic medical devices2018-03
Unique Device Identification (UDI) System under the EU Medical Device Regulations 2017/745 and 2017/746 – FAQs2019-08

European Databank on Medical Devices (EUDAMED)

Number Title Date
MDCG 2019-4Timelines for registration of device data elements in EUDAMED2019-04
MDCG
2019-5
Registration of legacy devices in EUDAMED2019-04

Clinical Investigation and Evaluation

Number TitleDate
MDCG 2019-9Summary of safety and clinical performance 2019-08

Other Topics

NumberTitleDate
MDCG 2019-11Guidance on Qualification and Classification of Software in Regulation (EU) 2017/745 – MDR and Regulation (EU) 2017/746 – IVDR 2019-10
MDCG 2019-10Application of transitional provisions concerning validity of certificates issued in accordance to Directives 90/385/EEC and 93/42/EEC 2019-10
MDCG 2019-3Interpretation of article 54 (2)b2019-03
MDCG 2019-8Guidance document implant card on the application of Article 18 Regulation (EU) 2017/745 on medical devices2019-03
MDCG 2019-7Guidance 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

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
MDDCouncil Directive 93/42/EEC on Medical Devices1993
AIMDDCouncil Directive 90/385/EEC on Active Implantable Medical Devices1990
IVDMD Council Directive 98/79/EC on In Vitro Diagnostic Medical Devices1998
2017/C 389/03Commission 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 V1.22Manual 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
2.1/6Qualification 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. 3Clinical 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 Medizinprodukte2012
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

NumberTitle Date
N52 FINAL:2019Principles of labelling for medical devices and IVD medical devices 2019-03
N48 FINAL:2019Unique 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
N43
FINAL:2019 (Edition 3)
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

N43 Annex A reference mapping

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

N43 Annex B reference mapping

Annex C: IMDRF terminologies for categorized adverse event reporting (AER): Investigation findings (‘what were the findings?’)

N43 Annex C reference mapping

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

N43 Annex D reference mapping

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

Annex F: IMDRF terminologies for categorized adverse event reporting (AER): Health impact
2019-03
N27 FINAL:2019 Assembly and technical guide for IMDRF table of contens submissions

IVD Template

nIVD Template
2018-11
N51 FINAL:2018Optimizing standards for regulatory use 2018-11
N47 FINAL:2018Essential principles of safety and performance of medical devices and IVD medical devices 2018-10
N46 FINAL:2018Tools for assessing the usability of registries in support of regulatory decision-making2018-03
N14
FINAL:2017 (Edition 2)
Medical devices: Post-market surveillance: National competent authority report exchange criteria and report form 2017-09
N41 FINAL:2017Software as a medical device (SaMD): Clinical evaluation 2017-09
N19 FINAL:2016Common data elements for medical device identification 2016-03
N24 FINAL:2015Medical device regulatory audit reports2015-10
N23 FINAL:201Software as a medical device (SaMD): Application of quality management system 2015-10
N12 FINAL:2014Software as a medical device: Possible framework for risk categorization and corresponding considerations 2014-09
N7 FINAL:2013UDI guidance: Unique device identification (UCI) of medical devices 2013-12
N10 FINAL:2013Software 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-N77Principles 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-N70Label and instructions for use for medical devices 2011-09
SG1-N063Summary 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 importer 2009-03
SG1-N044 Role of standards in the assessment of medical devices 2008-03
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
IMDRF/SaMD WG/N41FINAL:2017Software as a Medical Device (SAMD): Clinical Evaluation 2017-12
Postmarket Management of Cybersecurity in Medical Devices2016-12
Mobile Medical Applications 2015-02
Content of Premarket Submissions for Management of Cybersecurity in Medical Devices2014-10
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
MPAnpG-EUDraft 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
MPAnpG-EUMedizinprodukte-Anpassungsgesetz-EU
(Referentenentwurf)
2019-08
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
DIMDIVOrdinance on the Database-supported Information System on Medical Devices of the German Institute for Meidical Documentation and Information (DIMDI-Ordinance DIMDIV)

Verordnung über das datenbankgestützte Informationssystem über Medizinprodukte des Deutschen Instituts für Dokumentation und Information (DIMDIV)
2018-11
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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