As the summer draws to a close, we at Asphalion would like to share with you the latest regulatory updates that are shaping the MedTech landscape. Here’s a summary of the key changes and initiatives you should be aware of:
MDSAP: New Version of Audit Approach Document
Revision Date: 06-08-2024
Document: MDSAP AUDIT APPROACH – Document No: MDSAP AU P0002.009
Main Changes (Annex 5, page 160):
- Update/removal of certain Australian requirements linked to the Australian Sponsor.
- Ordinance MHLW MO169 references, aligned with ISO 13485:2003, have been fully removed, reflecting the March 2024 shift to solely acknowledge the 2021 amendment (in line with ISO 13485:2016).
Access the document here: MDSAP new version of audit approach
EUROPE – EMA’s New Pilot for Orphan Medical Devices
Published: 02-08-2024
EMA Pilot Program:
- Launch of a new pilot to support orphan medical devices.
- Medical device expert panels will offer free advice to manufacturers and notified bodies on these products.
Learn more: EMA’s New Pilot for Orphan Medical Devices
EUROPE – Survey on Electronic IFUs
European Commission (EC) Survey
- The EC is considering the expansion of electronic instructions for professional-use medical devices (currently limited to certain devices like implantable devices and software per Regulation 2021/2226).
- Healthcare professionals and others working in EU health institutions are encouraged to contribute their insights by responding to the survey before 11-10-2024.
Participate in the survey: Survey on Electronic IFUs
EUROPE – Renewal of UDI Issuing Entities
Decision Date: 30-07-2024
EC Decision: Implementation (EU) 2024/2120
- Renewal of the designation for four entities managing the UDI system for the next five years:
- GS1 AISBL.
- Health Industry Business Communications Council (HIBCC).
- International Council for Commonality in Blood Banking Automation (ICCBBA).
- Informationsstelle für Arzneispezialitäten (IFA) GmbH.
The decision is available here: Renewal of UDI Issuing Entities
SWITZERLAND – swissdamed Update
Effective: From 06-08-2024
- The ‘Actors’ module of swissdamed is now available for the registration of economic operators.
- Registrations must be applied for exclusively via https://www.swissdamed.ch/
Stay informed and compliant with Asphalion’s insights. For further assistance or queries on these updates, feel free to reach out to us.
Contact us at: [email protected]
