18:00 – 18:30
Light refreshments (sandwiches and drinks)
18:30 – 18:35
Introduction
Margareth Jorvid,
Methra Uppsala AB, LSM group
18:35 – 19:05
How has the MDR/IVDR changed the work at the Medical Products Agency
•
Experiences
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EUDAMED
•
Combination products
Lilian Nilsson, Medical Products Agency
19:05 - 19:35
How has MDR/IVDR changed the work at the company
•
Experience implementing MDR/IVDR
•
Combination products
•
MDR Art 117
Ann-Cathrin Jareman, Scandinavian Regulatory Services
Short break
19:45 - 20:15
Clinical testing of medical devices/combination products
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Application
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Safety reporting
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Experiences
Elin Karlberg, Medical Products Agency
20:15 – 20:45
Consultation for medical devices with medicinal substance
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Documentation requirements, what does MPA review?
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Transition to MDR for MDD products
Johan Sällström/Katarina Sundberg, Medical Products Agency
20:35 - 21:00
Time for questions and networking.
Pricing
TOPRA Members: Free [MPA employees - Free. Use code MPA200]
Non-member: £45 (includes 2 months TOPRA membership)
Contact us
Contact membership@topra.org or Margareth Jorvid at margareth.jorvid@lsmgroup.se, if you want to become TOPRA member.
Questions: toprainsweden@topra.org
How to register
Members:
- Use the 'Register now' form above to log in to the site with your TOPRA Member username and password.
- Once logged in click the 'Register Myself' button that will appear below.
Non-members:
- If you already have non-member account for this site, log in and then click the 'Register Myself' link that will appear below.
- If you do not have an account, create an account, then log in and click the 'Register Myself' link that will appear below.
Any questions, contact: toprainsweden@topra.org.