Kiwa Medical confirms participation at RAPS Europe 2026 in Lisbon
From 5 to 8 May 2026, Lisbon will host a new edition of RAPS Europe, one of the leading European events dedicated to Regulatory Affairs in the life sciences and medical devices sector.
Also in 2026, Kiwa Medical confirms its participation, reaffirming its commitment to supporting companies and manufacturers throughout the certification process and in achieving regulatory compliance.
RAPS Europe is an international benchmark event for healthcare regulatory professionals, offering regulatory updates, opportunities for discussion, and in depth insights into the key challenges affecting the European medical device market.
Kiwa Medical: expertise and support in Medical Device Certification
With over twenty years of experience in medical device certification, Kiwa Medical is recognized as one of the leading international players supporting companies throughout the entire product lifecycle.
During RAPS Europe 2026, the Kiwa Medical team will be available to share its expertise and provide up to date information on:
- Medical device certification under MDR and IVDR
- Clinical and technical evaluations
- Post market surveillance
- Audits and regulatory compliance activities
Participation in the event will be a valuable opportunity to gain deeper insight into certification processes and engage directly with industry experts on continuously evolving regulatory requirements.
Kiwa Medical presentations
As part of the RAPS Europe 2026 program, Kiwa Medical will actively contribute with three presentations, delivering technical and scientific insights on key MDR and IVDR regulatory topics.
“Clinical Evidence beyond Clinical Data: a practical approach considering current legislation and future outlook”
The first session will take place on Wednesday, 6 May 2026, from 12:00 to 13:00.
The presentation will be delivered by Natascha J. Cuper, Product Reviewer / Internal Clinician at Kiwa Assurance, and will offer a practical approach to clinical evidence that goes beyond clinical data alone, considering the current regulatory framework and future perspectives.
“Clinical Evidence as the Cornerstone of MDR Compliance: Lessons, Challenges, and the Road Ahead”
The second session will also be on Wednesday, 6 May 2026, from 14:30 to 15:30.
This will be presented by Marianna Mastroroberto, Clinical Expert Manager at Kiwa Italy. The session will explore the central role of clinical evidence in MDR compliance, focusing on lessons learned, key challenges, and expected regulatory developments.
“Change management: NBCG MED document on procedures and criteria for notification of changes under MDR/IVDR”
The third presentation will be on Thursday, 7 May 2026, from 14:00 to 14:25.
The presentation, hosted by Pietro Iannì, Sales Account Manager at Kiwa Italy, will introduce the new NBCG MED document on procedures and criteria for the notification of changes under MDR and IVDR, highlighting a harmonized approach to change management among Notified Bodies. This approach aims to improve consistency, predictability, and regulatory alignment across the European Union.
Regulatory affairs and innovation at the heart of RAPS Europe 2026
The RAPS Europe 2026 programme will focus on key European regulatory topics, including MDR/IVDR implementation, device change management, clinical evaluation, and the use of post market data to support compliance.
Within this context, Kiwa Medical’s presence and active contribution further demonstrate the company’s commitment to maintaining a leading role in the international regulatory dialogue.
A strategic event for the Medical Devices sector
For many years, RAPS Europe has represented a central hub for discussion and updates for all stakeholders involved in healthcare regulation. Kiwa Medical’s participation in 2026 confirms its ongoing commitment to providing high quality technical and scientific support and practical solutions to successfully address the regulatory challenges of the European market.
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Contact us for more information on Medical Device Certification services.