This site is part of the Informa Connect Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC's registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 3099067.

18 - 22 October 2021
Virtual EventDelivered in CEST time zone
keyboard_arrow_left
Hide

Day 1

List View
view_list
keyboard_arrow_right
keyboard_arrow_leftSearch & Filter
European Medical Device Regulations and Legal Adviceabout eventkeyboard_arrow_right
ON DEMAND: European Medical Device Regulations
ON DEMAND: Legal Advice for Medical Device Regulations
LIVE: European Medical Device Regulations
LIVE: Legal Advice for Medical Device Regulations
11:45 - 12:00
Chairpersons Opening Remarks
Chairpersons Opening Remarks
14:50 - 15:30
Virtual Audits: Why the Challenge?
Virtual Audits: Why the Challenge?
13:30 - 14:10
Spotlight Session
Spotlight Session

Navigate EU MDR regulatory compliance with expert guidance

14:50 - 15:30
Legal Perspective on New Medical Device UK Market Regulations
Legal Perspective on New Medical Device UK Market Regulations
Alex Denoon - Partner, Bristows LLP
14:45 - 14:50
Chairpersons Opening Remarks
Chairpersons Opening Remarks
14:10 - 14:45
Meet the on-demand speakers on the hub
Meet the on-demand speakers on the hub
10:00 - 10:20
Economic Operators: From Perfect Contracts to Contract Implementation - How to Avoid Pitfalls
Economic Operators: From Perfect Contracts to Contract Implementation - How to Avoid Pitfalls
Erik Vollebregt - Partner, Axon Lawyers, The Netherlands
10:20 - 10:40
Assessing Early Experiences with Economic Operators
Assessing Early Experiences with Economic Operators
Breskella Halteh - Sr. Manager, RAQA Compliance, Stryker
15:35 - 16:15
Spotlight Session
Spotlight Session

Please contact Linda Cole at: linda.cole@informa.com
+44 (0) 7990 006 998
if you are interested in participating as a sponsor and speaker, moderator or hosting a webinar.

17:45 - 18:00
Tech Tours
Tech Tours
15:35 - 16:15
Legal Perspective on Regulations for Digital Health and AI
Legal Perspective on Regulations for Digital Health and AI
Michaela Herron - Partner, Mason, Hayes & Curran
16:20 - 17:00
Contract Management for Acquisitions and Disposals of Assets
Contract Management for Acquisitions and Disposals of Assets
Alison Dennis - Partner, Taylor Wessing, UK
17:05 - 17:45
Legal Approaches to Companion Diagnostics and Combination Products
Legal Approaches to Companion Diagnostics and Combination Products
Peter Bogaert - Partner, Covington & Burling LLP, Belgium
10:20 - 10:40
PRRC Rules: Practical Advice on Responsibilities, Liabilities and Navigating ‘Grey Areas’
PRRC Rules: Practical Advice on Responsibilities, Liabilities and Navigating ‘Grey Areas’
12:45 - 13:25
Notified Body Feedback: Insight from EU MDR Implementation
Notified Body Feedback: Insight from EU MDR Implementation
Ella Helgeman - Regulatory and Quality Manager, Intertek
10:00 - 10:20
Lessons Learnt While Implementing the EU MDR
Lessons Learnt While Implementing the EU MDR
Juliette Cook - Regional Regulatory Director EMEA, Cochlear AG, Switzerland
18:00 - 18:05
End of Conference Day 1
End of Conference Day 1
10:40 - 11:00
Experiences with EU MDR Audits
Experiences with EU MDR Audits
12:00 - 12:40
Competent Authority Feedback: First 5 Months of the EU MDR
Competent Authority Feedback: First 5 Months of the EU MDR
Matthias Neumann - Senior Executive, Medical Device Safety Unit, German Federal Ministry of Health
11:00 - 11:45
Roundtables
Roundtables

Join this immersive roundtable session where thought-leaders will share their insights, knowledge and discuss the hottest MedTech topics

17:05 - 17:45
MDR Readiness: Where are we now and what is the impact on HCPs and Patients
MDR Readiness: Where are we now and what is the impact on HCPs and Patients
16:20 - 17:00
Industry Panel: Sharing Experiences with the EU MDR
Industry Panel: Sharing Experiences with the EU MDR
Juliette Cook - Regional Regulatory Director EMEA, Cochlear AG, Switzerland
Breskella Halteh - Sr. Manager, RAQA Compliance, Stryker
Robert van Boxtel - Principal Consultant, Medical Device Project B.V., The Netherlands
European Medical Device Regulations and Legal Advice - ON DEMAND: European Medical Device Regulations
10:00 - 10:20
Lessons Learnt While Implementing the EU MDR
  • Real experience with implementing the EU MDR  

  • Which processes worked as planned and which didn’t? 

  • Did the resource requirements (e.g. time, money and staff) match expectations?  

Juliette Cook - Regional Regulatory Director EMEA, Cochlear AG, Switzerland
10:20 - 10:40
Assessing Early Experiences with Economic Operators
  • First feedback on Economic Operators: How  does this work in reality?  

  • Early experiences with audits of Economic Operators  

  • Practical experiences with the impact on labelling and Economic Operators  

Breskella Halteh - Sr. Manager, RAQA Compliance, Stryker
10:40 - 11:00
Experiences with EU MDR Audits
  • Outlining expectations for an EU MDR audit 

  • Best practices to prepare for an audit 

  • Assessing feedback received from a Notified Body during an audit   

European Medical Device Regulations and Legal Advice - ON DEMAND: Legal Advice for Medical Device Regulations
10:00 - 10:20
Economic Operators: From Perfect Contracts to Contract Implementation - How to Avoid Pitfalls
  • Legal view on roles different players in field – distributors, NB, Manufacturers  

  • New obligations for economic operators and manufacturers supervisory requirements 

  • Troubleshooting common legal pitfalls for effective economic operator oversight  

  • Challenges when your EOs and distributors are within the same group of companies  

  • Key considerations around free movement of good and parallel trade of medical devices within the EU 

Erik Vollebregt - Partner, Axon Lawyers, The Netherlands
10:20 - 10:40
PRRC Rules: Practical Advice on Responsibilities, Liabilities and Navigating ‘Grey Areas’
European Medical Device Regulations and Legal Advice - LIVE: European Medical Device Regulations
11:45 - 12:00
Chairpersons Opening Remarks
12:00 - 12:40
Competent Authority Feedback: First 5 Months of the EU MDR
  • First experiences with the EU MDR  

  • Outlining what’s working well  

  • Addressing the common pitfalls with the EU MDR 

Matthias Neumann - Senior Executive, Medical Device Safety Unit, German Federal Ministry of Health
13:30 - 14:10
Spotlight Session

Navigate EU MDR regulatory compliance with expert guidance

14:10 - 14:45
Meet the on-demand speakers on the hub

Meet the on-demand speakers in the networking hub and ask your burning questions.


14:45 - 14:50
Chairpersons Opening Remarks
14:50 - 15:30
Virtual Audits: Why the Challenge?
  • Outlining the requirements of virtual audits  

  • Discussing the lack of harmonised standards for virtual audits 

  • Do the challenges of securing virtual audits highlight bigger problems with the EU MDR?  

15:35 - 16:15
Spotlight Session

Please contact Linda Cole at: linda.cole@informa.com
+44 (0) 7990 006 998
if you are interested in participating as a sponsor and speaker, moderator or hosting a webinar.

16:20 - 17:00
Industry Panel: Sharing Experiences with the EU MDR
  • Sharing industry best practices 

  • A chance to ask questions from the On-Demand presentations  

  • Recommended viewing prior to panel:  

  • Assessing Early Experiences with Economic Operators 

  • Lessons Learnt While Implementing the EU MDR  

Juliette Cook - Regional Regulatory Director EMEA, Cochlear AG, Switzerland
Breskella Halteh - Sr. Manager, RAQA Compliance, Stryker
Robert van Boxtel - Principal Consultant, Medical Device Project B.V., The Netherlands
17:05 - 17:45
MDR Readiness: Where are we now and what is the impact on HCPs and Patients
  • Feedback from hospitals – are they still accepting MDD registered products?
  • Is there a danger of losing products from outside Europe?  
  • Are there concerns of a lack of, or reduced stock of certain medical devices – what are the next steps
17:45 - 18:00
Tech Tours

These short medtech product and service demos will provide you with insights into the latest solutions available.

European Medical Device Regulations and Legal Advice - LIVE: Legal Advice for Medical Device Regulations
11:00 - 11:45
Roundtables

Join this immersive roundtable session where thought-leaders will share their insights, knowledge and discuss the hottest MedTech topics

12:45 - 13:25
Notified Body Feedback: Insight from EU MDR Implementation
  • Addressing common issues with applications found in the first 5 months of the EU MDR 

  • Feedback on the bottlenecks  

  • Sharing early lessons learnt  

Ella Helgeman - Regulatory and Quality Manager, Intertek
14:50 - 15:30
Legal Perspective on New Medical Device UK Market Regulations
  • What the UKCA mark and the UK(NI) mark mean for manufacturers  

  • Similarities and divergences between EU, NI and UK: Will the UK become a dumping ground or a proving ground?  

  • Latest information on new rules and systems to obtain UK CA market  

Alex Denoon - Partner, Bristows LLP
15:35 - 16:15
Legal Perspective on Regulations for Digital Health and AI
  • EU regulatory framework for medical device digital health and UK/MHRA divergences  

  • Addressing the up classification of software: how do you deal with significant changes?    

  • Examining IP and data compliance considerations for healthcare data and AI 

Michaela Herron - Partner, Mason, Hayes & Curran
16:20 - 17:00
Contract Management for Acquisitions and Disposals of Assets
  • Divest, merge or acquire understanding requirements for transference of CE mark 

  • Practical guidance and legal considerations for contract management 

  • Legal troubleshoot and advice for practical scenarios and challenges 

Alison Dennis - Partner, Taylor Wessing, UK
17:05 - 17:45
Legal Approaches to Companion Diagnostics and Combination Products
  • Practical and commercial aspects for co-packaged devices  

  • MDR consequences for drug - device and device - drug combination products  

  • IVDR consequences for companion diagnostics  

Peter Bogaert - Partner, Covington & Burling LLP, Belgium
18:00 - 18:05
End of Conference Day 1
Filter
Type
Events