Sponsor
Medboard: https://www.medboard.com/
Europe
Well-Established Technologies - Publication of the Delegated act: https://ec.europa.eu/newsroom/sante/newsletter-archives/77013
2 Delegated acts:
Class III and implantables: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=OJ:L_202601451
Class Iib implantables: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=OJ:L_202601359
In line with the Administrative Simplification Agenda
COMBINE Phase 2 - Increase of Scope : https://ec.europa.eu/newsroom/sante/newsletter-archives/76937
Incease of Scope:
Eligibility for multinational investigational medicinal product (IMP) clinical trials combined with:
Performance studies of IVDs or companion diagnostics requiring authorisation
Clinical investigations of medical devices requiring authorisation
Combined studies with Advanced Therapy Medicinal Products (ATMPs) possible
Options for single or separate sponsors
Procedure for substantial modifications in combined studies authorised in the pilot to be launched later in phase 2
Exploration of single protocols and joint documents
Austria: FSC deficiencies - Most issues identified: https://www.basg.gv.at/en/companies/medical-devices/certificate-of-free-sale/common-deficiencies
SSCP, Upload you should! - MDCG 2026-4 released: https://health.ec.europa.eu/document/download/a80332cf-e9f0-4d45-8863-3d96e8c2a675_en?filename=mdcg_2026-4_en.pdf
Start Date October 2026, Due date February 2027
Harmonized Standard update - A full list was disclosed: https://eur-lex.europa.eu/eli/dec_impl/2026/1231/oj
MDCG 2021-5 Rev 1 EU REP Symbol -Should you continue to use EC REP? https://health.ec.europa.eu/document/download/e10f7694-67b4-4093-a969-6f7e43747c44_en?filename=md_mdcg_2021_5_appendix_en.pdf
During the transition time, within a staggered approach for the implementation, it is acceptable to use one or both symbols ‘EC REP’ and ‘EU REP’ on different levels of packaging, as well
Team-NB- Micro Small Entreprise - Discount imposed https://www.team-nb.org/wp-content/uploads/2026/06/Team-NB-PositionPaper-Micro-Small-Entreprise-Initiatives-V1-20260616.pdf
UK
Update of UK Borderline Guide - Remove of antimicrobial substances as Medical Devices: https://www.gov.uk/government/publications/borderlines-with-medical-devices
The line: 'Alcohol-only pre-injection swabs and wipes are considered to be medical devices as are those containing anti-microbial substances such as chlorhexidine, cetrimide or iodine.'
has been changed to this:
Alcohol-only pre-injection swabs and wipes are considered to be medical devices.
Switzerland
Swissdamed: Registration
New option: M2M and Master UDI-DI: https://www.swissmedic.ch/swissmedic/en/home/medical-devices/medizinprodukte-datenbank/swissdamed-informationen/neu-online-editor-m2m-produktregistierung-master-udi.html
Swissdamed UDI User guide: https://www.swissmedic.ch/dam/swissmedic/en/dokumente/medizinprodukte/mep_urr/bw630_40_841e_hb_swissdamed_user_guide_udi_devices_module.pdf.download.pdf/BW630_40_841e_HB_swissdamed_User_Guide_UDI_Devices_Module.pdf
Medtech Conf: Medtechconf.com
Podcast
Episode 393 - Best of „AI CE marking“: https://podcast.easymedicaldevice.com/393-2/
Episode 394 - NC vs CAPA: Are You Opening the Wrong Records?: https://podcast.easymedicaldevice.com/394-2/
Episode 395 - “We’ve Never Had a Complaint” — The Most Dangerous Sentence in Medical Devices: https://podcast.easymedicaldevice.com/395-2/
Easy Medical Device
Consulting activities (CE marking, Clinical Evaluation, QMS creation…) https://easymedicaldevice.com/services/mdr-ivdr-technical-documentation/
BOSS Program: Back Office Services
eQMS: https://easymedicaldevice.com/smarteye-eqms/
EasyIFU: eIFU and Label creation: https://easymedicaldevice.com/easyifu/
Authorized Representative in EU, UK and Switzerland
Market access all over the world: https://easymedicaldevice.com/services/market-access/
Social Media to follow
Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
Twitter: https://twitter.com/elazzouzim
Pinterest: https://www.pinterest.com/easymedicaldevice
Instagram: https://www.instagram.com/easymedicaldevice
This podcast is hosted by Podcastics, the easiest platform to create and publish your podcast.
