The Medical Devices Regulation (MDR)

• MDR Conformity Assessment Routes in the AIMD space
• Extension to the MDR transition timelines
• Understanding Periodic Safety Update Reports and submitting to BSI
• Preparing a Summary of Safety and Clinical Performance (SSCP)
• Preparing a Post Market Clinical Follow Up Plan & Evaluation Report
• Preparing a Clinical Evaluation Report (Part 2)
• Preparing a Clinical Evaluation Report (Part 1)
• Preparing a Clinical Evaluation Plan
• Article 54 Understanding the Clinical Evaluation Consultation Process
• Post market clinical follow up under MDR
• Clinical evaluation for medical software & AI devices
• Claiming equivalence under the MDR – regulatory considerations
• Understanding Article 61 (10) – When Clinical Data is not deemed appropriate
• Well-established technologies - defining the criteria from MDCG 2020-6
• AIMDD to MDR transition - what you need to know
• Active Implantable Medical Devices under the EU MDR at MedTech Summit 2021
• Personalised Medical Devices - what you need to know
• The Periodic Safety Update Report (PSUR) & Vigilance under the MDR
• MDR Rule 14 Devices – conformity assessment process and submissions
• MDR lessons learnt
• Clinical evaluation under the MDR – do you understand the requirements?
• Hear BSI’s Dr Jayanth Katta talk at the MedTech Digital Week
• BSI’s perspectives on Article 117 and drug-device combinations
• MDR - What we currently know
• Article 120 - What is due in 2020?
• MDR Conformity Assessment Routes
• Medicines and Biologics
• MDR Article 18 Implant Card
• Update to the regulatory implications of Brexit
• Medical devices incorporating biological tissue: MDR requirements
• QMS aspects of the MDR (& IVDR)
• EU Harmonization – MDR Requirements & progress on key standards & labelling
• General Safety and Performance Requirements in the New MDR
• Technical Documentation requirements under MDR, including requirements for legacy files
• Medical Device Regulation - what you need to know
• MDR & IVDR - Roles in the regulatory system
• New version of MEDDEV 2.7.1 Revision 4: Key changes and clarifications

The In Vitro Diagnostic Regulation (IVDR)

• Pathways to IVDR compliance
• Navigating the complex IVDR landscape
• IVDR Lessons Learnt
• ISO 20916 IVD — Clinical performance studies
• Maintaining your CE Certification under the IVDR, a Lifecycle approach
• Performance Evaluation under the In Vitro Diagnostic Regulation (IVDR) – Part 2
• Performance Evaluation under the In Vitro Diagnostic Regulation (IVDR) – Part 1
• Understanding the QMS requirements under the IVD Regulation
• In Vitro Diagnostic Regulation (IVDR) Conformity Assessment Routes
• In Vitro Diagnostic Regulation (IVDR) Application Process
• How ready are you for the IVD Regulation?
• Update to the regulatory implications of Brexit
• General Safety and Performance requirements of the IVDR
• MDR & IVDR - Roles in the regulatory system
• QMS aspects of the MDR (& IVDR)
• In Vitro Diagnostic Regulation - what you need to know

QMS, ISO 13485, MDSAP and medical device standards

• Symbols to be used on labelling (ISO 15223) and information from manufacturer (ISO 20417)
• ISO 14971:2019 Risk Management for Medical Devices
• Update to the regulatory implications of Brexit
• QMS aspects of the MDR (& IVDR)
• EU Harmonization – MDR requirements & progress on key standards & labelling
• Critical update on Medical Device Single Audit Program (MDSAP): Countdown for Canada
• Are you ready for the Medical Device Single Audit Program (MDSAP)?
• New versions of ISO 13485:2016 and ISO 9001:2015
• ISO 13485:2016 publication

Market access requirements

• Hybrid audits the new way of working post pandemic
• UKCA Medical Devices - are you ready for the future?
• Person Responsible for Regulatory Compliance
• UKCA for Medical devices and IVDs, are you ready?
• BSI update on the new UKCA and future UK regulation for Medical Devices and IVDs
• Post Market Surveillance and Vigilance - do you know the requirements?
• Usability engineering, a new focus: Do you understand the requirements?
• Nanomaterials and Medical Device Regulations
• Validation and Verification, are you clear on the requirements?
• Electro-Medical Device Market Access: Frequently Asked Questions