| 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 |
| MDR Factsheet | The EU’s Medical Devices Regulation | TUV |
| 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 |
| 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 | An introductory guide to the medical device regulation (MDR) and the in vitro diagnostic medical device regulation | MHRA |
| Planning for implementation of the European Union Medical Devices Regulations – Are you prepared? | BSI |
| IVD Manufacturers step by step | Implementation Model for In-Vitro Diagnostic Medical Devices Regulation Step by Step Guide | EC |
MD
Classification | MDR Classification
Annex VIII | BSI |
| Classification changes | BSI |
| IVD Classification | Explaining IVD classification issues | BSI |
| European Medical Device Nomenclature (EMDN) | The European Medical Device Nomenclature (EMDN) – the nomenclature of use in EUDAMED | EC |
| The CND Nomenclature | EC |
| Labelling | Principles of Labelling – IMDRF/GRRP WG/N52 FINAL:2019 | IMDRF |
| UDI | Unique Device Identification (UDI) System – FAQs | EC |
| UDI Implementation Update | MHRA |
| Udi_in_europe | GS1 |
| 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 |
| UDI system – IMDRF/UDI WG/N48 FINAL: 2019 | IMDRF |
| UDI Guidance – IMDRF/UDI WG/N7 FINAL:2013 | IMDRF |
| Guidance on UDI for systems and procedure packs – MDCG 2018-3 Rev.1 | EC |
| UDI compliance | BSI |
| What you need to know about the FDA’s UDI system final rule | BSI |
| 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 |
| Drug-device combinations | Guideline quality requirements drug-device combinations_en-1.pdf | EMA |
| Sterilization | Sterilization – Regulatory requirements and
supporting standards | BSI |
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 Route | MDR Conformity Assessment Routes Guidance | BSI |
| MDR Documentation | MDR Documentation Submissions Best Practice Guidelines | BSI |
| MDR Mapping Guide | BSI |
| IVDR Documentation | IVDR Documentation Submissions Best Practice Guidelines | 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 |
| IVDR Transition | IVDR Readiness Review | BSI |
| Developing and maintaining a quality management system for IVDs | BSI |
| MDR FAQ | MDR Frequently Asked Questions | BSI |
| CAMD Transition Sub Group FAQ – MDR Transitional provisions | EC |
| IVDR FAQ | IVDR Frequently Asked Questions | BSI |
| Notified Body | BSI Guide to Notified Body | BSI |
| 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 |
| 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 |
| Cybersecurity | MDCG 2019-16 – Guidande on Cybersecurity for medical devices | EC |
| Principles and Practices for Medical Device Cybersecurity – IMDRF/CYBER WG/N60FINAL:2020 | IMDRF |
| Cybersecurity of medical devices -Addressing patient safety and the security of patient health information | BSI |
| 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 |
| Clinical Evaluation – IMDRF MDCE WG/N56FINAL:2019 | IMDRF |
| Clinical Investigation – IMDRF MDCE WG/N57FINAL:2019 | IMDRF |
| Clinical Evidence – IMDRF MDCE WG/N55 FINAL:2019 | IMDRF |
| Medical device clinical investigations – What’s new under the MDR? | BSI |
| MDSAP | MDSAP Assessment and Decision Process – IMDRF/MDSAP WG/N11 FINAL:2014 | IMDRF |
| 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 |
| Surveillance & Vigilance | Manufacturer incident report 2020 | EC |
| 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 |
| 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 |
| 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 |