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Technical Documentation to Comply with the MDR and IVDR Training Course

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.

29-30 Sep 2020

& 8-9 Mar 2021 , 10-11 Mar 2021 , 22-23 Nov 2021 , 24-25 Nov 2021

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Details

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

Programme

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

Presenters

Will Burton (More...)

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.

Paul Sim (More...)

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.

Book now

Book now

29-30 Sep 2020
Live webinar
29-30 Sep 2020
Live webinar
GBP 1,099.00
EUR 1,579.00
USD 1,786.00
Until 18 Aug*
Enrol now
to attend
Live webinar
8-9 Mar 2021
Face-to-face, (venue not yet confirmed)
8-9 Mar 2021
Face-to-face
(venue not yet confirmed)
GBP 1,299.00
EUR 1,819.00
USD 2,026.00
Until 25 Jan 21*
Enrol now
to attend
Face-to-face
(venue not yet confirmed)
  • 2 days of classroom-based training
  • Meet presenters and fellow attendees in person
  • Lunch and refreshments provided
  • Download documentation and certification of completion
  • Fair transfer and cancellation policy
10-11 Mar 2021
Live webinar
10-11 Mar 2021
Live webinar
GBP 1,099.00
EUR 1,579.00
USD 1,786.00
Until 27 Jan 21*
Enrol now
to attend
Live webinar
22-23 Nov 2021
Face-to-face, (venue not yet confirmed)
22-23 Nov 2021
Face-to-face
(venue not yet confirmed)
GBP 1,299.00
EUR 1,819.00
USD 2,026.00
Until 11 Oct 21*
Enrol now
to attend
Face-to-face
(venue not yet confirmed)
  • 2 days of classroom-based training
  • Meet presenters and fellow attendees in person
  • Lunch and refreshments provided
  • Download documentation and certification of completion
  • Fair transfer and cancellation policy
24-25 Nov 2021
Live webinar
24-25 Nov 2021
Live webinar
GBP 1,099.00
EUR 1,579.00
USD 1,786.00
Until 13 Oct 21*
Enrol now
to attend
Live webinar

Learn more about our face-to-face and webinar training formats.

* Note the early booking discount cannot be combined with any other offers or promotional code

Customised in-house training

We can customise this course to meet the requirements of your organisation and deliver it at your location and/or online.

Contact us

Previous customers include...

  • Bayer AG
  • CSL Behring AG
  • Halyard Belgium BVBA (Avanos)
  • Medigen Regulatory Limited
  • Presspart
  • Ramsay MD-Regs Ltd
  • Saudi Food and Drug Authority

The content, presentations and workshops were delivered by experts in the field, who engaged the delegates and involved them in discussions.

Tina Aspinall, Consultant, Medigen Regulatory Limited, May 19

Very good speaks with a lot of experience.

Jens Martens , Regulatory Affairs Officer , Halyard Belgium BVBA (Avanos), May 19

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.

Paul Fitton, Regulatory Affairs Specialist, Presspart, May 19