Barco Nv · EURONEXT:BAR
Barco Nv — Master the new MDR regulation webinar (May 2023)
31 slides from Barco Nv's conference presentation, May 16, 2023
Slide 1: Master the new MDR regulation
Master the new MDR regulation Webinar 16th of May 2023
Slide 2: Introducing the Barco webinar hosts
Katrien Cardoen Healthcare Compliance Director Introducing the Barco Joerg Herrmann Sales Director EMEA webinar hosts Diagnostic Imaging Julie Vandecandelaere Regulatory Officer 2 ● Webinar master the new MDR regulation
Slide 3: Pushing the world forward through innovation
Pushing the world forward through innovation 1930s 1950s 1980s 2010s 1940s 1960s 2000 2020s 3 ● Webinar master the new MDR regulation
Slide 4: We are closer to you than you think
We are closer to you than you think Enterprise Entertainment Healthcare 4 ● Webinar master the new MDR regulation
Slide 5: Enabling quality care for more people
Enabling quality care for more people Dentistry Breast Imaging Teleradiology Surgery Dermatology Interventional radiology Digital Pathology Radiology Auditorium Lobby Boardroom & meeting room 5 ● Webinar master the new MDR regulation
Slide 6: Poll 1: Do you know what has changed from MDD to MDR?
Poll 1 Do you know what has changed from MDD to MDR? 6 ● Webinar master the new MDR regulation
Slide 7: Answer Poll 1
Answer Poll 1 • Applicable and binding in all EU • New guidance documents member states • Increased evidence of compliance • No grandfathering • Traceability • Applies to all economic operators • Increased focus on feedback loops • Life-cycle approach • State of the Art • Updated classification rule
Slide 8: Answer Poll 1
Answer Poll 1 ✓ Applicable and binding in all EU ✓ New guidance documents member states ✓ Increased evidence of compliance ✓ No grandfathering ✓ Traceability ✓ Applies to all economic operators ✓ Increased focus on feedback loops ✓ Life-cycle approach ✓ State of the Art ✓ Updated classification rule
Slide 9: EU Medical Device Regulation 2017/745
EU Medical Device Regulation 2017/745 Increasing patient safety through transparency, documentation and scientific evidence Why a new regulation? 2017 the EU MDR was issued • Several scandals showed that the • A state-of-the-art regulation: EU directive did not protect the impacting all Medical Devi
Slide 10: Impact on the EU market
Impact on the EU market There are more than 500 000 Product need to be medical devices safe for the patient no matter where they placed on the market within are designed or EU with a very broad range produced of application 10 ● Webinar master the new MDR regulation
Slide 11: Poll 2: What is driving the classification of medical devices?
Poll 2 What is driving the classification of medical devices? 11 ● Webinar master the new MDR regulation
Slide 12: Poll 2
Poll 2 A The classification assigned to similar products on the market B The intended purpose assigned by the legal manufacturer C The usage within a hospital environment 12 ● Webinar master the new MDR regulation
Slide 13: Answer Poll 2
Answer Poll 2 A The classification assigned to similar products on the market B The intended purpose assigned by the legal manufacturer C The usage within a hospital environment 13 ● Webinar master the new MDR regulation
Slide 14: What is a medical device?
What is a medical device? The intended purpose assigned by the legal manufacturer A B A B 14 ● Webinar master the new MDR regulation
Slide 15: Increasing risk
High risk Medical devices Class III Notify Body Classification approval Class IIb Increasing risk required and conformity assessment Class IIa Self-assesment Class I Low risk 15 ● Webinar master the new MDR regulation
Slide 16: How existing displays are affected
How existing displays are affected Classification What is the Medical based on ALL intended device 22 rules purpose? or not? RULE 10 YES applies Class IIa 16 ● Webinar master the new MDR regulation
Slide 17: The significance of rule 10 of the MDR
Class IIa The significance of rule 10 of the MDR Rule 10 covers a whole A diagnostic display is A diagnostic display is range of equipment in an active device and is intended to allow various fields for intended for direct diagnosis capture of physiological diagnosis because the because it provides
Slide 18: Portfolio
Class IIa Portfolio QAWeb Enterprise Breast imaging Radiology display systems display systems Intuitive workflow tools Spotview, I-Luminate, AAM, Digital Pathology Dental Filmclip displays displays 18 ● Webinar master the new MDR regulation
Slide 19: How does it affect our IWT software solution?
How does it affect our IWT software solution? Classification What is the Medical device based on ALL intended or not? 22 rules purpose? RULE 11 YES applies Class IIa 19 ● Webinar master the new MDR regulation
Slide 20: How does it affect our QAWeb Enterprise software solution?
Class IIa How does it affect our QAWeb Enterprise software solution? What is the Accessory to a Driving or Accessory intended medical device influencing? to medical purpose? or not? device YES YES Following class of the devices supported 20 ● Webinar master the new MDR regulation
Slide 21: Barco classification summary
Class IIa Barco classification summary Diagnostic display Intuitive Workflow Tools QAWeb Enterprise 21 ● Webinar master the new MDR regulation
Slide 22: Displays with similar intended purpose are classified as class I
Class I Displays with similar intended purpose are classified as class I Other manufacturer • This product is intended to be used in displaying and use ± the same viewing digital images for review, analysis and intended purpose diagnosis by trained medical practitioners. It does not support the disp
Slide 23: What it takes to receive class IIa certification
Class IIa What it takes to receive class IIa certification Class I devices are Class IIa devices are • Quality Management System placed on the placed on the market after a is audited to be in line with EU market after self- notified body assessment MDR certification by the and certification • Techni
Slide 24: The hidden risks that class I presents in diagnostic environments
The hidden risks that class I presents in diagnostic environments Class I devices without the involvement of a notified body • They are not being scrutinized, have no medical device file reviews • Have no EU MDR audits – no check on compliance to MDR (is different than ISO 13485) • Nobody is reviewi
Slide 25: How can you recognize a class IIa device?
How can you recognize a class IIa device? EU Declaration of Label Scope MDR certificate Conformity (DoC) 25 ● Webinar master the new MDR regulation
Slide 26: Poll 3: Which of the following statements is not correct?
Poll 3 Which of the following statements is not correct? 26 ● Webinar master the new MDR regulation
Slide 27: Poll 3
Poll 3 A B C D Class I medical Only products On the product Manufacturers of devices can be designed and/or label of a class IIa class IIa devices self-certified whilst manufactured product, the CE can only make class IIa medical in the EU need to Mark is always claims when they devices need a compl
Slide 28: Answer Poll 3
Answer Poll 3 A B C D Class I medical Only products On the product Manufacturers of devices can be designed and/or label of a class IIa class IIa devices self-certified whilst manufactured product, the CE can only make class IIa medical in the EU need to Mark is always claims when they devices need
Slide 29: Barco.com/healthcare
Barco.com/healthcare Our newsletter BarcoHealth on LinkedIn & Twitter 29 ● Webinar master the new MDR regulation
Slide 30: Any questions?
Any questions? 30 ● Webinar master the new MDR regulation
Slide 31: Visioneering a bright tomorrow
Visioneering a bright tomorrow
Barco — Master the new MDR regulation webinar (May 2023) on 6ix