Medical Device NewsMAY 2024 Regulatory Update Medical Device made Easy Podcast

EU

Notified Bodies

TUV SUD Denmark under MDR –Welcome to the Brother or Sister: https://api.tech.ec.europa.eu/nando-prod/files?repo=nando&id=150a0abbc0d4397086d648963fc940a321e02c11&group=NOTIFICATION&download=true

AFNOR 46th NB under MDR –Finally a second one for France: https://webgate.ec.europa.eu/single-market-compliance-space/#/notified-bodies/notifications?organizationRefeCd=EPOS_43655&filter=notificationStatusId:1

MDCG 2024-4 Guidance–Safety reporting in Performance Studies or IVD: https://health.ec.europa.eu/document/download/5cc894e0-331d-4fa2-8ab3-cdd4437c48fc_en?filename=mdcg_2024-4_en.pdf

Form: https://view.officeapps.live.com/op/view.aspx?src=https%3A%2F%2Fhealth.ec.europa.eu%2Fdocument%2Fdownload%2F54cbbfd4-5808-4560-93ef-017f2a3b0f41_en%3Ffilename%3Dmdcg_2024-4_appendix_en.xlsm&wdOrigin=BROWSELINK

MDCG 2024-5 Guidance – SInvestigator's Brochure for Clinical Investigation: https://health.ec.europa.eu/document/download/ee7ee8eb-841a-4085-a8dc-af6d55ebf1bd_en?filename=mdcg_2024-5_en.pdf

Checklist 2024-5 https://health.ec.europa.eu/document/download/a387e3e7-65e3-4af5-bb98-2281949feded_en?filename=mdcg_2024-5-appendix-a_en.docx

 Survey Article 17 – Reprocessing of single use devices: https://op.europa.eu/o/opportal-service/download-handler?identifier=35ea0c60-e82c-11ee-9ea8-01aa75ed71a1&format=pdf&language=en&productionSystem=cellar&part=

 

 

 Team-NB: ESMINT initiative –  Call for expert: https://www.team-nb.org/esmint-initiative/

 Spain AEMPS Bulletin on Health Products –  From Jan - March 2024: https://www.aemps.gob.es/informa/boletin-sobre-productos-sanitarios-enero-marzo-de-2024/#vigProdSan

 Germany: Classification - Bfarm to help you classify your device: https://www.bfarm.de/DE/Medizinprodukte/Antraege-und-Meldungen/Antrag-auf-Klassifizierung/_artikel.html

 Swiss: SaMD –  information sheet to help Software companies: https://www.swissmedic.ch/dam/swissmedic/en/dokumente/medizinprodukte/mep_urr/bw630_30_007d_mbmedizinprodukte-software.pdf.download.pdf/BW630_30_007e_MB%20Medical%20Device%20Software.pdf

Turkey: 26 May 2024 –  Reminder of the May 26th, 2024 deadline for EU MDR https://titck.gov.tr/duyuru/imalatcisi-tarafindan-sure-uzatimindan-faydalanmayacak-urunlerin-uts-surecleri-24042024160706

 

Article to read

European Medical Writers Association – Focus on Translation: https://journal.emwa.org/media/5111/mew-331-final.pdf

 

Training

Training EU MDR –  Green Belt Certification Program GB31 May 2024: https://school.easymedicaldevice.com/course/gb31/

 Malaysia training –  Calendar 2024: https://portal.mda.gov.my/index.php/doclink/mda-core-training-list-2024-latest-nur-izzati-adha-binti-zuman-mda-pdf/eyJ0eXAiOiJKV1QiLCJhbGciOiJIUzI1NiJ9.eyJzdWIiOiJtZGEtY29yZS10cmFpbmluZy1saXN0LTIwMjQtbGF0ZXN0LW51ci1penphdGktYWRoYS1iaW50aS16dW1hbi1tZGEtcGRmIiwiaWF0IjoxNzE0MDEwNjUyLCJleHAiOjE3MTQwOTcwNTJ9.1KCY_1RCNi1mnJSCP30llN8kaBvcBJU6G_JMpc-OttI

Team-NB training  -  IVDR technical Documentation July 3rd, 2024: https://www.team-nb.org/fourth-session-ivdr-technical-documentation-training-for-manufacturers/

 

Events

 Events –  Check Medtech Conf: https://MedtechConf.com

 

Rest of the world

 South Korea: Certificate Check –Verifying authenticity of certificates issued by MDFS: https://emedi.mfds.go.kr/msismext/emd/uif/issuDocTruflsEngView.do

 South Korea: IVD method –How to register IVD in South Korea: https://www.law.go.kr/%EB%B2%95%EB%A0%B9/%EC%B2%B4%EC%99%B8%EC%A7%84%EB%8B%A8%EC%9D%98%EB%A3%8C%EA%B8%B0%EA%B8%B0%EB%B2%95/(19695,20230816)

 South Korea: UDI rules to follow –Same but not the same: https://www.mfds.go.kr/eng/brd/m_40/down.do?brd_id=eng0011&seq=72636&data_tp=A&file_seq=1

 Mexico: Draft Mexican official standard –Labelling of Medical Devices: https://www.dof.gob.mx/nota_detalle.php?codigo=5724246&fecha=23/04/2024#gsc.tab=0

 Australia: Consultation on IFU –  Call for more flexibility: https://www.tga.gov.au/resources/cons