| 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 |