European Commission (EC) Documents

MD Manufacturers Factsheet for Manufacturers of Medical DevicesEC
Implementation Model for Medical Devices Regulation Step by Step GuideEC
IVD Manufacturers step by stepImplementation Model for In-Vitro Diagnostic Medical Devices Regulation Step by Step GuideEC
European Medical Device Nomenclature (EMDN)The European Medical Device Nomenclature (EMDN) – the nomenclature of use in EUDAMEDEC
The CND NomenclatureEC
UDIUnique Device Identification (UDI) System – FAQsEC
MDCG 2018-1 v3 Guidance on BASIC UDI-DI and changes to UDI-DIEC
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 745/2017EC
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 packsEC
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 2017/746EC
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 2017/745EC
Guidance on UDI for systems and procedure packs – MDCG 2018-3 Rev.1EC
EUDAMEDMDCG 2020-15 MDCG Position Paper on the use of the EUDAMED actor registration module and of the Single Registration Number (SRN) in the Member StatesEC
MDCG 2019-4 Timelines for registration of device data elements in EUDAMEDEC
MDCG 2019-5 Registration of legacy devices in EUDAMED EC
ART 15
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)
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 devicesEC
ART 54MDCG 2019-3 Interpretation of Article 54(2)b rev 1EC
ART 120 Transitional provisionsMDCG 2020-2 Class I Transitional provisions under Article 120 (3 and 4) – (MDR)EC
MDR FAQCAMD Transition Sub Group FAQ – MDR Transitional provisionsEC
Notified BodyMDCG 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 tissuesEC
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 AIMDDEC
MDCG 2019-14 Explanatory note on MDR codesEC
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/EECEC
MDCG 2019-6 v2 Questions and answers: Requirements relating to notified bodies EC
Guidance on Content of the certificates, voluntary certificate transfers EC
CybersecurityMDCG 2019-16 – Guidande on Cybersecurity for medical devicesEC
Clinical Investigation and EvaluationMDCG 2020-13 Clinical evaluation assessment report templateEC
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 v1.0EC
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 bodiesEC
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 bodiesEC
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 2019EC
Surveillance & VigilanceManufacturer incident report 2020 EC
SoftwareGuidance on Qualification and Classification of Software in Regulation (EU) 2017/745 – MDR and Regulation (EU) 2017/746 – IVDR EC
Other documentsMDCG 2020-9 Regulatory Requirements for Ventilators and Related AccessoriesEC
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) propertiesEC

British Standard Institution (BSI) Documents

Safety & Performance
General Safety and Performance Requirements (Annex I) in the New medical Device RegulationBSI
Technical DocumentationTechnical Documentation and Medical
Device Regulation – A Guide for Manufacturers to Ensure Technical Documentation Complies with EU Medical Device Regulation 2017/745
MD OperatorsImporters, distributors and assemblersBSI
Responsible persons
The role of the person responsible for regulatory compliance
Authorized representativesBSI
Responsible persons, authorized representatives and the new EU RegulationsBSI
MDR IVDR GuidancePlanning 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 marketBSI
Roles in the Regulatory System
MDR Classification
Annex VIII
Classification changesBSI
IVD ClassificationExplaining IVD classification issuesBSI
UDIUDI complianceBSI
What you need to know about the FDA’s UDI system final ruleBSI
SterilizationSterilization – Regulatory requirements and
supporting standards
MDR RouteMDR Conformity Assessment Routes Guidance BSI
MDR DocumentationMDR Documentation Submissions Best Practice Guidelines BSI
MDR Mapping Guide BSI
Medical Devices Regulation Impact on ResourcesBSI
Medical Devices Regulation What you need to knowBSI
IVDR DocumentationIVDR Documentation Submissions Best Practice Guidelines BSI
IVDR Update WebinarBSI
MDR TransitionMDR 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 MDDBSI
IVDR TransitionIVDR Readiness Review BSI
Developing and maintaining a quality management system for IVDsBSI
MDR FAQMDR Frequently Asked Questions BSI
IVDR FAQIVDR Frequently Asked Questions BSI
Notified BodyBSI Guide to Notified Body BSI
ISO 13485:2016ISO 13485 Frequently Asked Questions BSI
The differences and similarities between ISO 9001:2015 and ISO 13485:2016BSI
ISO 13485 – The proposed changes and what they mean for youBSI
Risk ManagementRisk management for medical devices and the new BS EN ISO 14971BSI
MEDDEV 2.7.1 Revision 4The Top Ten Changes in MedDev 2.7.1 Rev 4 BSI
MDR ImplementationHow to prepare for and implement the upcoming MDR – Dos and don’tsBSI
IVDR ImplementationHow to prepare for and implement the upcoming IVDR – Dos and don’tsBSI
CybersecurityCybersecurity of medical devices -Addressing patient safety and the security of patient health informationBSI
Clinical Investigation and EvaluationMedical device clinical investigations – What’s new under the MDR?BSI
Clinical Evidence Requirements – Key Changes and ClarificationsBSI
LabellingMDR – Labelling RequirementsBSI
Post MarketThe Post-Market PriorityBSI
Post-market surveillanceBSI
Effective post-market surveillance – Understanding and conducting vigilance
and post-market clinical follow-up
How to get to the market and stay there!BSI
Enhanced PMCFBSI
Surveillance & VigilanceDo 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?
Other documentsRecent Advancements in Al – implications for medical device technology and certificationBSI
Digital maturity in an age of digital excitementBSI
Machine Learning AI in Medical DevicesBSI
What does the future look like for the medical devices industry?
The impact and potential for 3D printing and
bioprinting in the medical devices industry
Engaging stakeholders in the home medical device marketBSI
Negotiating the innovation and regulatory conundrumBSI
The growing role of human factors and usability engineering for medical devicesBSI
BSI Webinar – Person Responsible for Regulatory ComplianceBSI
Nanomaterials and medical device regulationsBSI

TÜV Documents

Documents of Other Authors

MDR IVDR GuidanceAn introductory guide to the medical device regulation (MDR) and the in vitro diagnostic medical device regulationMHRA
LabellingPrinciples of Labelling – IMDRF/GRRP WG/N52 FINAL:2019IMDRF
UDIUDI Implementation UpdateMHRA
Drug-Device CombinationsGuideline quality requirements drug-device combinations_en-1.pdfEMA
CybersecurityPrinciples and Practices for Medical Device Cybersecurity – IMDRF/CYBER WG/N60FINAL:2020IMDRF
Clinical Investigation and EvaluationClinical Evaluation – IMDRF MDCE WG/N56FINAL:2019IMDRF
Clinical Investigation – IMDRF MDCE WG/N57FINAL:2019IMDRF
MDSAPMDSAP Assessment and Decision Process – IMDRF/MDSAP WG/N11 FINAL:2014IMDRF