Semi Annual EU Medical Device Regulatory Affairs Conference

November 13-14, 2019 | Brussels, Belgium

Park Inn by Radisson Brussels Airport

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DAY TWO | THURSDAY, NOVEMBER 14

7:30 REGISTRATION & COFFEE

8:00 CHAIRPERSON’S OPENING REMARKS
Annabelle Bruyndonckx, Counsel, SIMMONS & SIMMONS

8:15 PANEL DISCUSSION: COMPARING METHODS TO APPLY PROACTIVE POST-MARKET SURVEILLANCE & VIGILANCE

  • Defining a proactive approach for the product life-cycle
  • Special case of legacy devices with ongoing certificates
  • Organizing a comprehensive chain of requirements
  • Strategic planning when juggling multiple product lines

Fayez Abou Hamad, TERUMO EUROPE

Bart Mersseman, SGS BELGIUM

Kemine Hale, ADVANCED BIONICS

 

9:00 MASTERCLASS: DELVING INTO COMPLIANCE STRATEGIES TO FULFILL ECONOMIC OPERATOR REQUIREMENTS
Under the umbrella of economic operators, the MDR introduces new definitions and roles for individuals and organizations throughout the supply chain of a medical product. While roles are fairly straightforward, definitions are interpreted differently from one member state to the other, resulting in confusion as to whether certain organizations such as healthcare institutions are considered operators and must therefore be registered through EUDAMED, as well as how to establish a compliant partnership with the medical device industry. In addition, regulatory affairs teams ask how much control can be taken over the practical application of compliance verifications by importers and distributors, unsure how to best address the new task.

PART 1 – CLARIFYING GREY AREAS IN ECONOMIC OPERATOR ESTABLISHMENT

  • Mapping a comprehensive supply chain under the MDR
  • Impact on partnerships & EUDAMED registrations
  • Demystifying supply chain verification obligations
  • Specifics for non-EU manufacturing companies

Momchil Blagoev, Director Corporate Regulatory Affairs, EDWARDS LIFE SCIENCES

 

9:45 PART 2 – EXCHANGE GROUPS: PRACTICAL APPROACH TO SUPPLY CHAIN VERIFICATIONS BY COMPANY SIZE
As larger organizations commonly have direct representation in target markets while smaller companies partner with importers and distributors, structuring the most efficient and compliant plan to ensure all necessary verifications are conducted by operators is predominantly dependent on the manufacturing company size. Many involved in importer and distributor partnerships currently raise questions related to the limits of the manufacturer’s capacity to manage partners, which is unclear at this time. In order to avoid redundant controls within a same group, or with the aim to efficiently prepare economic operator partners for compliance, supply chain verification strategies will be compared and debated in small groups divided by company size, to ensure the most acute learning experience for all participants.

GROUP 1: Large (>500 employees)

GROUP 2: Medium (100 to 500 employees)

GROUP3: Small (<100 employees)

Michel Marboeuf, Senior Director Corporate Regulatory Affairs, STRYKER

 

10:15 COFFEE & NETWORKING BREAK

 

10:45 PRACTICAL INDUSTRY CASE STUDY: INSIDE LOOK INTO THE ONGOING MANAGEMENT OF THE REGULATORY SHIFT
With common areas of challenges pertinent to staffing, budgeting, planning operations in a time and resource-efficient manner, making decisions towards legacy product lines and more, device manufacturers of all classes have applied various methodologies to ensure a swift transition towards the regulation. While handling the update as a company-wide project has proven successful for many organizations, further areas of change must still be managed in limited time. With the goal of learning from peers’ experience, taking a practical dive into a regulatory teams’ from different company sizes state of advancement and how final operations are currently being organized promises insight into important benchmarks and techniques to organize remaining actions necessary to complete in order to reach compliance by the deadline.

Juliette Cook, Regional Regulatory Director EMEA, COCHLEAR

 

11:15 EXCHANGE GROUPS: PRIORITIZATION & REGULATORY MANAGEMENT OF PRODUCT LINES WITH STRICT MAY 2020 COMPLIANCE
While certain devices will benefit from a grace period for compliance with the MDR, thanks to MDD certificates extending beyond May of 2020, many others need to meet compliance by the deadline. Regulatory teams are focusing primarily on such product lines in order to achieve updates and align with new provisions, and are anxious to understand from peers’ similar experiences how to optimize the management and completion of remaining tasks in limited time. Enabling direct insight sharing and collection with other regulatory professionals, the exchange group format encourages participants to compare and debate strategies to learn from each other and take away practical information.

GROUP 1: Devices with certificates expiring close to May 2020:
Elizabeth Gfoeller, MED EL

GROUP 2: Devices with no prior certificates & class I up-classified:
Bassil Akra, VP Global Strategic Business DevelopmentTÜV SÜD Product Service

GROUP 3: Class Ir devices: Rita Peeters, JOHNSON & JOHNSON

 

12:00 OPEN FORUM: FIELDING QUESTIONS TO DIVE INTO SPECIFIC AREAS OF CONCERN
This interactive session will enable the audience to address questions pertinent to practical definitions and approaches to MDR implementation, in order to assist individual participants in obtaining clarity into more specific areas of ongoing uncertainty. Addressing a panel of regulatory experts from the industry, professionals are given the opportunity to submit questions during the first day and a half of the event, related to topics for which presentations are delivered, or different challenges that have not been discussed. Questions will be collected by the Q1 Productions Managers on site, before being submitted to the panel for analysis and review during the session.

MODERATOR: Jens Pfannkuche, PENUMBRA EUROPE

PANELISTS:
Momchil Blagoev, EDWARDS LIFE SCIENCES

Elizabeth Gfoeller, MED EL

Erik Raadsheer, ALIGN TECHNOLOGY

 

12:45 LUNCHEON FOR ALL PARTICIPANTS

 

1:45 PRAGMATIC FOCUS ON OUTLINING A COMPREHENSIVE QMS TO PREPARE FOR MDR AUDITS

  • Technical documentation compliance specifics:
    • Addressing risk in the product life-cycle
    • Insights into process manufacturing
  • ISO 13485:2016 relevance with MDR compliance
  • Objective forecast of MDR audit scenarios
  • Expected timeline for the first MDR audits

Hendrik Heinze, Director of Quality & Regulatory, BERLIN HEART

 

2:15 SHEDDING LIGHT INTO GREY AREAS FOR SOFTWARE COMPLIANCE WITH THE MDR

  • Determining whether software & apps are MDR regulated
  • Deciphering medical device software classification via rule 11
  • Clinical consequences

Koen Cobbaert, Chair Software Focus Group, COCIR
Senior Manager – Quality, Standards & Regulations, PHILIPS

 

3:00 CLAIMS UNDER THE MDR: FOCUS ON COMPLIANCE WITH ARTICLE 7
MDR Article 7 aims towards more substantiation of medical device product claims to avoid misleading consumer through unclear communications. Similar to the pharmaceutical industry, all product labelling materials including the instructions for use as well as promotional and marketing communications, must disclose likely risks in the use of the medical device in a clear and transparent manner. With potential differences in interpretation of the provision among member states, and challenges in reaching a consensus in defining “likely risk”, regulatory teams require clarification to ensure compliance.

  • Review of MDR Article 7 & related requirements
  • Insights into interpretation issues
  • Towards a definition of “likely risk”
  • Claims review process: practical advice
  • Sufficiently addressing risk in materials

Annabelle Bruyndonckx, Counsel, SIMMONS & SIMMONS

Vladimir Murovec, Associate, Life Sciences, SIMMONS & SIMMONS

 

3:45 CLOSING REMARKS & CONFERENCE CONCLUSION

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