MDR Guidance Documents - Medical Device Regulation

European Commission (EC) Documents

TOPIC	Title	Author
MD Manufacturers	Factsheet for Manufacturers of Medical Devices	EC
	Implementation Model for Medical Devices Regulation Step by Step Guide	EC
	MDCG 2019-15 GUIDANCE NOTES FOR MANUFACTURERS OF CLASS I MEDICAL DEVICES	EC
IVD Manufacturers step by step	Implementation Model for In-Vitro Diagnostic Medical Devices Regulation Step by Step Guide	EC
European Medical Device Nomenclature (EMDN)	The European Medical Device Nomenclature (EMDN) – the nomenclature of use in EUDAMED	EC
	The CND Nomenclature	EC
UDI	Unique Device Identification (UDI) System – FAQs	EC
	MDCG 2018-1 v3 Guidance on BASIC UDI-DI and changes to UDI-DI	EC
	MDCG 2019-1 MDCG guiding principles for issuing entities rules on Basic UDI-DI	EC
	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 745/2017	EC
	MDCG 2018-2 Future EU medical device nomenclature – Description of requirements	EC
	MDCG 2018-4 Annex: UDI database Definitions/Descriptions and formats of the UDI core elements for systems or procedure packs	EC
	MDCG 2018-5 UDI Assignment to Medical Device Software	EC
	MDCG 2018-6 Clarifications of UDI related responsibilities in relation to Article 16 of the Medical Device Regulation 2017/745 and the In-Vitro Diagnostic Medical Devices Regulation 2017/746	EC
	MDCG 2018-7 Provisional considerations regarding the language issues associated with the UDI database (Annex VI, Part A Section 2 and Part B of the Medical Devices Regulation 2017/745 and the In-Vitro Diagnostic Medical Device Regulation 2017/745	EC
	Guidance on UDI for systems and procedure packs – MDCG 2018-3 Rev.1	EC
EUDAMED	MDCG 2020-15 MDCG Position Paper on the use of the EUDAMED actor registration module and of the Single Registration Number (SRN) in the Member States	EC
	MDCG 2019-4 Timelines for registration of device data elements in EUDAMED	EC
	MDCG 2019-5 Registration of legacy devices in EUDAMED	EC
ART 15 PRRC	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)	EC
ART 18 Implant Card	MDCG 2019-8 v2 – Guidance document – Implant 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 devices	EC
ART 54	MDCG 2019-3 Interpretation of Article 54(2)b rev 1	EC
ART 120 Transitional provisions	MDCG 2020-2 Class I Transitional provisions under Article 120 (3 and 4) – (MDR)	EC
MDR FAQ	CAMD Transition Sub Group FAQ – MDR Transitional provisions	EC
Notified Body	MDCG 2020-14 Guidance 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)	EC
	MDCG 2020-12 Transitional provisions for consultations of authorities on devices incorporating a substance which may be considered a medicinal product […] as well as on devices manufactured using TSE susceptible animal tissues	EC
	MDCG 2020-11 Guidance 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	EC
	MDCG 2020-4 Guidance on temporary extraordinary measures related to medical device Notified Body audits during COVID-19 quarantine orders and travel restrictions	EC
	MDCG 2020-3 Guidance on significant changes regarding the transitional provision under Article 120 of the MDR with regard to devices covered by certificates according to MDD or AIMDD	EC
	MDCG 2019-14 Explanatory note on MDR codes	EC
	MDCG 2019-13 Guidance on sampling of MDR Class IIa / Class IIb and IVDR Class B / Class C devices for the assessment of the technical documentation	EC
	MDCG 2019-12 Designating authority’s final assessment form: Key Information (EN)	EC
	MDCG 2019-10 Application of transitional provisions concerning validity of certificates issued in accordance to Directives 90/385/EEC and 93/42/EEC	EC
	MDCG 2019-6 v2 Questions and answers: Requirements relating to notified bodies	EC
	Guidance on Content of the certificates, voluntary certificate transfers	EC
Cybersecurity	MDCG 2019-16 – Guidande on Cybersecurity for medical devices	EC
Clinical Investigation and Evaluation	MDCG 2020-13 Clinical evaluation assessment report template	EC
	MDCG 2020-10/1 Safety reporting in clinical investigations of medical devices under the Regulation (EU) 2017/745	EC
	MDCG 2020-10/2 Clinical Investigation Summary Safety Report Form v1.0	EC
	MDCG 2020-8 Post-market clinical follow-up (PMCF) Evaluation Report Template. A guide for manufacturers and notified bodies	EC
	MDCG 2020-7 Post-market clinical follow-up (PMCF) Plan Template. A guide for manufacturers and notified bodies	EC
	MDCG 2020-6 Regulation (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 bodies	EC
	MDCG 2020-5 Clinical Evaluation – Equivalence. A guide for manufacturers and notified bodies	EC
	MDCG 2020-1 Guidance on Clinical Evaluation (MDR) / Performance Evaluation (IVDR) of Medical Device Software	EC
	MDCG 2019-9 Summary of safety and clinical performance A guide for manufacturers and notified bodies – August 2019	EC
Surveillance & Vigilance	Manufacturer incident report 2020	EC
Software	Guidance on Qualification and Classification of Software in Regulation (EU) 2017/745 – MDR and Regulation (EU) 2017/746 – IVDR	EC
Other documents	MDCG 2020-9 Regulatory Requirements for Ventilators and Related Accessories	EC
	Guidelines on the benefit-risk assessment of the presence of phthalates in certain medical devices covering phthalates which are carcinogenic, mutagenic, toxic to reproduction (CMR) or have endocrine-disrupting (ED) properties	EC

British Standard Institution (BSI) Documents

TOPIC	Title	Author
Safety & Performance Requirements	General Safety and Performance Requirements (Annex I) in the New medical Device Regulation	BSI
Technical Documentation	Technical Documentation and Medical Device Regulation – A Guide for Manufacturers to Ensure Technical Documentation Complies with EU Medical Device Regulation 2017/745	BSI
MD Operators	Importers, distributors and assemblers	BSI
	Responsible persons The role of the person responsible for regulatory compliance	BSI
	Authorized representatives	BSI
	Responsible persons, authorized representatives and the new EU Regulations	BSI
MDR IVDR Guidance	Planning for implementation of the European Union Medical Devices Regulations – Are you prepared?	BSI
	The proposed EU regulations for medical and in vitro diagnostic devices – An overview of the likely outcomes and the consequences for the market	BSI
	MDR & IVDR – Roles in the Regulatory System	BSI
MD Classification	MDR Classification Annex VIII	BSI
	Classification changes	BSI
IVD Classification	Explaining IVD classification issues	BSI
UDI	UDI compliance	BSI
	What you need to know about the FDA’s UDI system final rule	BSI
Sterilization	Sterilization – Regulatory requirements and supporting standards	BSI
MDR Route	MDR Conformity Assessment Routes Guidance	BSI
MDR Documentation	MDR Documentation Submissions Best Practice Guidelines	BSI
	MDR Mapping Guide	BSI
	Medical Devices Regulation Impact on Resources	BSI
	Medical Devices Regulation What you need to know	BSI
IVDR Documentation	IVDR Documentation Submissions Best Practice Guidelines	BSI
	IVDR Update Webinar	BSI
MDR Transition	MDR Readiness Review	BSI
	Comparison of the annexes of the European Medical Devices Directive (93/42/EEC) and the Medical Devices Regulation ((EU) 2017/745)	BSI
	Comparison of the articles of the European Medical Devices Directive (93/42/EEC) and the Medical Devices Regulation ((EU) 2017/745)	BSI
	Relationship between the MDR and the former MDD	BSI
IVDR Transition	IVDR Readiness Review	BSI
	Developing and maintaining a quality management system for IVDs	BSI
MDR FAQ	MDR Frequently Asked Questions	BSI
IVDR FAQ	IVDR Frequently Asked Questions	BSI
Notified Body	BSI Guide to Notified Body	BSI
ISO 13485:2016	ISO 13485 Frequently Asked Questions	BSI
	The differences and similarities between ISO 9001:2015 and ISO 13485:2016	BSI
	ISO 13485 – The proposed changes and what they mean for you	BSI
Risk Management	Risk management for medical devices and the new BS EN ISO 14971	BSI
MEDDEV 2.7.1 Revision 4	The Top Ten Changes in MedDev 2.7.1 Rev 4	BSI
MDR Implementation	How to prepare for and implement the upcoming MDR – Dos and don’ts	BSI
IVDR Implementation	How to prepare for and implement the upcoming IVDR – Dos and don’ts	BSI
Cybersecurity	Cybersecurity of medical devices -Addressing patient safety and the security of patient health information	BSI
Clinical Investigation and Evaluation	Medical device clinical investigations – What’s new under the MDR?	BSI
	Clinical Evidence Requirements – Key Changes and Clarifications	BSI
Labelling	MDR – Labelling Requirements	BSI
Post Market	The Post-Market Priority	BSI
	Post-market surveillance	BSI
	Effective post-market surveillance – Understanding and conducting vigilance and post-market clinical follow-up	BSI
	How to get to the market and stay there!	BSI
	Enhanced PMCF	BSI
Surveillance & Vigilance	Do you know the requirements and your responsibilities for medical device vigilance reporting?	BSI
	The European Medical Devices Regulations What are the requirements for vigilance reporting and post-market surveillance?	BSI
Other documents	Recent Advancements in Al – implications for medical device technology and certification	BSI
	Digital maturity in an age of digital excitement	BSI
	Machine Learning AI in Medical Devices	BSI
	Nanotechnology What does the future look like for the medical devices industry?	BSI
	The impact and potential for 3D printing and bioprinting in the medical devices industry	BSI
	Engaging stakeholders in the home medical device market	BSI
	Negotiating the innovation and regulatory conundrum	BSI
	The growing role of human factors and usability engineering for medical devices	BSI
	BSI Webinar – Person Responsible for Regulatory Compliance	BSI
	Nanomaterials and medical device regulations	BSI

TÜV Documents

TOPIC	Title	Author
MDR Factsheet	The EU’s Medical Devices Regulation	TÜV
	Reprocessing, products liability, and other issues	TÜV
	Implementation Timeline	TÜV
Notified Body	Changing Roles of NB, Designation of NB, Impact of a reduced number of NB	TÜV
MDR Transition	Increased Scope of “Medical Devices” and Accessories	TÜV
UDI	UDI and Traceability EUDAMED	TÜV
Surveillance & Vigilance	Control over supply and distribution chains	TÜV

Documents of Other Authors

TOPIC	Title	Author
MDR IVDR Guidance	An introductory guide to the medical device regulation (MDR) and the in vitro diagnostic medical device regulation	MHRA
Labelling	Principles of Labelling – IMDRF/GRRP WG/N52 FINAL:2019	IMDRF
UDI	UDI Implementation Update	MHRA
	Udi_in_europe	GS1
	UDI system – IMDRF/UDI WG/N48 FINAL: 2019	IMDRF
	UDI Guidance – IMDRF/UDI WG/N7 FINAL:2013	IMDRF
Drug-Device Combinations	Guideline quality requirements drug-device combinations_en-1.pdf	EMA
Cybersecurity	Principles and Practices for Medical Device Cybersecurity – IMDRF/CYBER WG/N60FINAL:2020	IMDRF
Clinical Investigation and Evaluation	Clinical Evaluation – IMDRF MDCE WG/N56FINAL:2019	IMDRF
	Clinical Investigation – IMDRF MDCE WG/N57FINAL:2019	IMDRF
MDSAP	MDSAP Assessment and Decision Process – IMDRF/MDSAP WG/N11 FINAL:2014	IMDRF