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 ONE | WEDNESDAY, NOVEMBER 13

7:45 REGISTRATION & WELCOME COFFEE

8:30 CHAIRPERSON’S OPENING REMARKS
Michel Marboeuf, Senior Director Corporate Regulatory Affairs, STRYKER

8:40 OPENING ICE BREAKER: SHARING VALUABLE LESSONS LEARNED IN MANAGING THE MDR REGULATORY TRANSITION
The opening ice breaker will kick-off the event with an opportunity for all participants to move around the conference room to meet new delegates and engage in short and targeted discussions focused on insights into current levels of advancement in the regulatory transition towards the new rules, and sharing 2 important lessons learned so far. Furthermore, participants in this warm-up session have the chance to build contacts with industry peers at the very start of the event, kicking off the program networking platform.

 

9:00 KEYNOTE: STATE OF MDR IMPLEMENTATION & RELATED GUIDANCE RELEASE
With 6 months available to finalize a continent-wide update to the MDR, medical device professionals are anxious for increased insight into new developments that will influence industry’s as well as regulators’ strategies for implementation. Many questions remain, in particular for implementing and delegated acts, and the impact on member state implementation of new rules. Furthermore, insight from MDCG guidance is much anticipated, in order to rapidly draft an efficient approach to EU provisions. Finally, recent developments in member states such as the Netherlands shed additional light on enhanced and new requirements for the industry to comply with in limited time.

Dr Matthias Neumann, Deputy Head, Medical Devices Safety Unit
BMG, GERMAN FEDERAL MINISTRY OF HEALTH

 

9:45 COFFEE & NETWORKING BREAK

 

10:15 INTERVIEW: COMPETENT AUTHORITY INSIGHTS IN MDR INTERPRETATION & IMPLEMENTATION
As the medical device industry continues to prepare for the MDR implementation deadline in May of 2020, lingering questions and areas of uncertainty persist with differing interpretations of the rules by member states. Regulatory affairs executives strive for clarity and a unified approach of competent authorities towards the practical implementation of the regulation, in order to efficiently structure corporate plans for compliance. This interview session led by an industry representative will enable the audience to address specific questions to competent authority members, with the aim of unveiling timely and helpful information, all while clarifying areas of divergence among European regulators.

INTERVIEWER: Rita Peeters, Sr Director Regulatory Affairs Policy & Intelligence EMEA
JOHNSON & JOHNSON

INTERVIEWEES: Valérie Nys, MDR Program Manager
FAMHP – FEDERAL AGENCY FOR MEDICINES & HEALTH PRODUCTS, BELGIUM

Dr Matthias Neumann, Deputy Head, Medical Devices Safety Unit, BMG, GERMAN FEDERAL MINISTRY OF HEALTH

 

11:15 INFLUENCE OF NOTIFIED BODY READINESS ON MANUFACTURERS’ PREPARATION FOR MAY 2020
As the compliance date of May 2020 rapidly approaches, the medical device industry raises pressing concerns with a decreasing number of notified bodies applying for a full scope of product code designation under the MDR. Regulatory teams are challenged by the lack of ability to objectively forecast whether existing NB partners will remain available in the months to come, which families of products the notified body will certify under the MDR and in which timeframe before the deadline. In an effort to ensure MDR preparedness in manufacturing organizations all while taking into account ongoing areas of uncertainty, regulatory professionals aim to design plans of action adaptable to a variety of likely notified body outcomes.

PART 1 – PANEL DISCUSSION: NB REDESIGNATION & PRODUCT CERTIFICATION CAPACITY STATUS

  • Perspectives on expected number of NBs by May 2020
  • Product review capacity by family of medical devices
  • Certification timelines & potential review congestion

Bassil Akra, TÜV SÜD

Bart Mersseman, SGS BELGIUM

Michael Bothe, DQS MEDIZINPRODUKTE

 

12:00 LUNCHEON FOR ALL PARTICIPANTS

 

1:00 INFLUENCE OF NOTIFIED BODY READINESS ON MANUFACTURERS’ PREPARATION FOR MAY 2020 – Continued

PART 2 – WORKSHOP: PROACTIVE SUBMISSION PLANNING TO OVERCOME EXPECTED NB CERTIFICATION CHALLENGES
With ongoing concerns in notified body readiness and difficulties in forecasting timely certification capabilities, structuring a regulatory strategy that factors in unknowns is critical. Focusing on scenario planning, and the possibility of having a limited number of notified bodies available by May 2020, this workshop targets calculated preparation of submissions in light of restricted notified body capacity. The audience will engage in interactive brainstorming and debating of solutions to best plan for each scenario presented, diving into a practical approach to product line and operations prioritization to ensure preparedness regardless of current uncertainties.

Erik Raadsheer, ALIGN TECHNOLOGY

 

2:00 PART 3 – CASE STUDY: CHANGING NOTIFIED BODIES ALL WHILE TRANSITIONING TO THE MDR

  • Rationale for moving from one NB to another
  • Optimizing resource allocation:
    • Team management
    • Splitting time
    • Financial impact
  • Prioritization of regulatory operations
  • Challenges overcome & lessons learned

Andrea Sparti, Regulatory Affairs Manager, CENDRES+MÉTAUX

 

2:30 EFFICIENT MANAGEMENT OF DEVICE SIGNIFICANT CHANGES ACCORDING TO MDR ARTICLE 120(3)
While Article 120(3) of the MDR allows for devices with MDD or AIMD certificates to be placed on the market after May 2020, eligible products must fit a number of conditions. At this time, many regulatory affairs teams raise questions pertinent to the exact definition of “significant changes”, to ensure a sound approach to the need to recertify under the MDR. Additionally, concerns lie in the capacity of notified bodies to review such files and provide necessary responses to manufacturers in due time.

  • Review & simplification of MDR Article 120(3)
  • Practical examples of device “significant changes”
  • NB assessment of changes & compliance timeline

PART 1 – NB PERSPECTIVE:
Bassil Akra, VP Global Strategic Business DevelopmentTÜV SÜD Product Service

 

3:00 COFFEE & NETWORKING BREAK

 

3:30 EFFICIENT MANAGEMENT OF DEVICE SIGNIFICANT CHANGES ACCORDING TO MDR ARTICLE 120(3) – Continued

PART 2 – INDUSTRY PERSPECTIVE:
Frank Matzek, VP Regulatory & Governmental Affairs, BIOTRONIK

 

4:00 PANEL DISCUSSION: COMPARING INTERPRETATIONS IN THE NATURE & VOLUME OF DATA TO ACHIEVE SUFFICIENT CLINICAL EVIDENCE
The MDR introduces enhanced requirements for clinical research, including the need for manufacturers to provide sufficient clinical evidence to authorities in both the pre and post-market setting. When developing a comprehensive clinical evaluation plan that will fulfill new provisions, regulatory teams strive to design a strategy targeting the right quantity and quality of evidence, and are confronted with varying interpretations. While reaching a general consensus on the definition of “sufficient” clinical evidence is greatly desired at this time, it is also pivotal to consider the influence of the device design and functionalities to carve an accurate plan, ultimately enabling a clearer picture of the nature and volume of data to generate, collect and submit for compliance.

  • Evidence targets based on clinical study type
  • Means of relevant data generation & collection
  • Examples of acceptable data based on device class
  • Collection sources for post-market information
  • Influence of product maturity on the type of evidence

Bassil Akra, TÜV SÜD PRODUCT SERVICE

Carine Cochereau, INTEGRA LIFESCIENCE

Kemine Hale, ADVANCED BIONICS

 

4:45 PRACTICAL EUDAMED INSIGHTS: PORTAL LAUNCH STATUS & REQUIRED DATA ENTRIES

  • Current status & forecast of EUDAMED launch
  • Clarification of necessary data to enter & timelines
  • Differences with further international databases
  • Addressing technical requirements for UDI entries
  • Preparing for compliance despite EUDAMED delays

Mary Gray, Associate Director EU MDR UDI, JOHNSON & JOHNSON

 

5:30 CLOSING REMARKS & DAY 1 CONCLUSION

 

6:30 CONTINUED NETWORKING: FACILITATED GROUP DINNER
With the immense value in peer-to-peer interaction and experience sharing, we wish to provide attendees with an opportunity to continue networking after the first day of the conference. Q1 Productions will arrange dinner reservations at local restaurants close to the conference hotel for those interested in joining a group of fellow participants for dinner on November 13th. Please note that dinner expenses must be covered by each participant individually.

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We hope to see you at the conference!

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