Presented by
Management Forum

Technical Documentation to Comply with the MDR and IVDR

This seminar will provide essential guidance on the content of the technical documentation file, the changes required and the practicalities of compiling and maintaining the technical file to comply with the MDR and IVDR.

25-26 May 2022 + 1 more date

Enrol now

  • Format: Live online
  • CPD: 12 hours for your records
  • Certificate of completion

Course overview

Before placing a medical device on the European market, manufacturers need to produce technical documentation providing evidence of conformity with the relevant legislation.

From the 26 May 2020, technical documentation needs to comply with the Medical Device Regulation (MDR) (EU) Regulation 2017/745. Manufacturers’ who already have products on the market under the MDD (Medical Device Directive) or AIMDD (Active Implantable Medical Device Directive) who wish to obtain or renew a CE certificate or issue a Declaration of Conformity (DoC), will eventually have to revise their technical documentation to comply with the MDR at the latest by 27 May 2024.

Furthermore, manufacturers of In-Vitro Diagnostic Devices will also need to revise their technical documentation to comply with the In-Vitro Diagnostic Regulation (IVDR) (EU) Regulation 2017/746 by the 26 May 2022.

The new MDR and IVDR impacts manufacturers, stakeholders, Competent Authorities (CAs) and Notified Bodies (NBs) on how the technical documentation should be developed and maintained. The requirements have been raised and will be subject to more scrutiny by the CA and NB.

This seminar will provide essential guidance on the content of the technical documentation file, the changes required and the practicalities of compiling and maintaining the technical file to comply with the MDR and IVDR. Our expert trainers will guide you through the requirements and give you practical advice on how to manage the life cycle of the technical file.

Who should attend?

  • Medical device regulatory affairs professionals
  • IVD regulatory affairs professionals
  • R&D personnel creating technical documentation
  • Quality managers/associates
  • Product managers
  • Business development managers

Enrol now

The Technical Documentation to Comply with the MDR and IVDR course will cover:

Overview of the MDR and IVDR

  • Key changes

Technical documentation/file content

Workshop: Compiling the technical documentation

Quality management system (QMS)

  • Design control
  • Risk management
  • User requirements specification
  • Functional requirement specification
  • Risk analysis
  • Clinical evaluation

Workshop: Quality management system (QMS)

Notified Body experience

  • Absorption substances
  • IVD reagent products
  • Other interested parties/stakeholders

Labelling

  • Unique device identifier (UDI)
  • Instructions for use (IFU)
  • Single use devices

Workshop: Labelling

Post market surveillance

  • Post market surveillance plan
  • PMS report
  • Periodic Safety Update Report (PSUR)
  • Post market clinical follow up (PMCF)

Conformity assessment

  • Review of technical documentation

Person responsible for regulatory compliance

Requirements related to authorised representatives

Check list for technical documentation

  • Summary of changes from the MDD to MDR  
  • Requirements for archiving technical documentation

Enrol now

Will Burton

Will Burton, Director of Russell Square Quality Representatives (RSQR) Ltd, is engaged in providing a range of consultancy and training services to the international medical device, pharmaceutical and biotechnology industry sectors. Prior to founding RSQA in 1995, Will was the Professional Services Manager of the Manufacturer Registration Scheme Business Unit of the UK Medical Devices Agency (now MHRA).

He is a Pharmacist, Medicinal Product Qualified Person, Medical Device Expert and registered international lead assessor. He managed the UK team of medical device expert assessors performing worldwide quality systems audits of medical device manufacturers against the requirements of the Department of Health’s Quality Systems Documents which formed the foundation for ISO 13485. He has very extensive auditing and quality systems experience and was closely involved in the selection, training and monitoring of UK Notified Bodies. He continues to perform QMS audits to ISO 13485 worldwide and has lectured internationally on related topics.

More details

Paul Sim

Paul Sim, Regulatory Affairs Manager, BSi Group. Paul has worked in the healthcare industry for 34 years and is currently Project Managing BSI’s implementation of EU Commission Recommendation 2013/473/EU dealing with Unannounced Audits. Joining BSI in August 2010 leading the BSI effort working with the Saudi Food & Drug Authority on the implementation of the SFDA Medical Device Interim Regulations.

Previously he held senior RAQA leadership positions at Spacelabs Healthcare, Teleflex Medical, Smiths Medical, Ohmeda (formerly The BOC Group healthcare business)

Medical Device experience is across a very broad range of devices including: anaesthesia systems, patient monitors, vapourisers, ventilators, breathing circuits, single use sterile disposables and devices for re-use, infant warmers, incubators, steralisers, autoclaves, operating tables, infusion pumps and associated disposables, urinary catheters, surgical instruments, diagnostic cardiology etc.

Paul is a member of the Association of British Healthcare Industries (ABHI) Technical Policy Group and is Convenor of the ABHI ISO TC 210 Mirror Group. Convenor of the BSI Committee, which monitors all of the work undertaken by ISO TC 210, and Convenor of the BSI Sub-committee dealing with Quality Systems. As UK Delegation Leader to ISO TC 210, Paul is also actively involved in the work of national, European and international standards’ committees, dealing with revisions to the ISO 9000 series, ISO 13485, ISO 14971, ISO 15223 and others. He is Deputy Chairman and Council Member of Barema (British Anaesthetic & Respiratory Manufacturers Association), also a Member of the Association of Anaesthetists of Great Britain and Ireland (AAGBI) Safety Committee.

More details

Book Technical Documentation to Comply with the MDR and IVDR Live online training

25-26 May 2022

Live online

09:30-17:00 UK (London) (UTC+01)
10:30-18:00 Paris (UTC+02)
04:30-12:00 New York (UTC-04)
Course code 11569

  • GBP 1,099 1,299
  • EUR 1,579 1,859
  • USD 1,786 2,098

Until 20 Apr

View basket 

22-23 Nov 2022

Live online

09:30-17:00 UK (London) (UTC+00)
10:30-18:00 Paris (UTC+01)
04:30-12:00 New York (UTC-05)
Course code 11772

  • GBP 1,099 1,299
  • EUR 1,579 1,859
  • USD 1,786 2,098

Until 18 Oct

View basket 

Reviews of IPI's Technical Documentation to Comply with the MDR and IVDR training course


Very good and would recommend. Paul and Will both had very good knowledge of the MDR and complimented each other very well. Paul and Will also took time to answer individual questions.

May 8 2019

Paul Fitton
Regulatory Affairs Specialist, Presspart

May 8 2019

Very good speaks with a lot of experience.

Jens Martens
Regulatory Affairs Officer , Halyard Belgium BVBA (Avanos)

UK

  • Medigen Regulatory Limited
  • Presspart
  • Ramsay MD-Regs Ltd
  • Teva Pharmaceuticals

Belgium

  • Halyard Belgium BVBA (Avanos)

Germany

  • Bayer AG

Saudi Arabia

  • Saudi Food and Drug Authority

Switzerland

  • CSL Behring AG

Enrol now

Multiple colleagues?
Talk to one of our training experts to discuss how to:

Run this course conveniently and cost-effectively in-house for your staff and colleagues

Aleksandra BEER
Training expert

+44 (0)20 7749 4749

inhouse@ipi.academy