Medical Device News – December 2022 update

Training.
December 12th till December 16th https://school.easymedicaldevice.com/product/gb.

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#easymedicaldevice #medicaldevice #regulatorycompliance.

► Rest of the globe.
USA: EUA Template for Developers of Antigen Diagnostic Tests (MonkeyPox).
– https://www.fda.gov/medical-devices/emergency-use-authorizations-medical-devices/monkeypox-emergency-use-authorizations-medical-devices#templates.
USA: MedSun Newsletter – November 2022.
– https://www.fda.gov/media/162771/download.
Canada: List of identified criteria for clinical tools:.
– https://www.canada.ca/content/dam/hc-sc/documents/services/drugs-health-products/medical-devices/standards/list-recognized-standards-medical-devices-guidance/list-recognized-standards-medical-devices-guidance.pdf.
Canada: November 8, 2022 updates to listing of clinical tools for compulsory lack as well as discontinuation coverage.
– https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/establishment-licences/medical-devices-compliance-bulletin/11-08-changes-reporting-medical-device-shortage.html.
Barhain: Reminder Regarding Deadline for Medical Devices as well as Supplies Authorized Representatives Registration.
– https://www.nhra.bh/Media/Announcement/MediaHandler/ImageHandler/documents/Announcements/Announcement2022_Circular No. (35) 2022_To Medical Devices Importers and also Suppliers_Deadline for Medical Devices Supplies Authorized Reps Registration_20221124. pdf.

Call us at EO@easymedicaldevice.com if you look for an Authorized Representative or Importer in the European location.

■ 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.

– https://www.nhra.bh/Media/Announcement/MediaHandler/ImageHandler/documents/Announcements/Announcement2022_Circular No. (35) 2022_To Medical Devices Importers as well as Suppliers_Deadline for Medical Devices Supplies Authorized Reps Registration_20221124. – Episode 206: ** Regulatory Pathway: How to get to the United States market?

► PODCASTS:.
– Episode 205: ** Your Software/IVD medical record is totally WRONG! https://podcast.easymedicaldevice.com/205/.
– Episode 206: ** Regulatory Pathway: How to get to the United States market?
– Episode 207: ** Why Risk Management is essential to Medical Device advancement? https://podcast.easymedicaldevice.com/207-2/.
Episode 208: ** How to select the very best Sterilization Method for Medical Devices? https://podcast.easymedicaldevice.com/208-2/.

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► Social Media to adhere to.

► HOT TOPICS
Europe
Usual specs for the teams of items without a desired clinical objective noted in Annex XVI to Regulation (EU) 2017/745
– https://webgate.ec.europa.eu/regdel/#/implementingActs/7377?lang=en
– https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32022R2346
Reclassification of teams of specific energetic items without a desired clinical objective
– https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=celex%3A32022R2347
Upgraded info pack for prospect EU referral research laboratories released
– https://health.ec.europa.eu/latest-updates/updated-information-pack-candidate-eu-reference-laboratories-published-2022-11-30_en
51th CAMD Meeting Statement (The European Competent Authorities for Medical Devices (CAMD)).
– https://www.camd-europe.eu/other/51th-camd-meeting-statement/.
MDCG 2022-16: Guidance on Authorised Representatives Regulation.
– https://health.ec.europa.eu/system/files/2022-10/mdcg_202216_en.pdf.
New Notified Body EU MDR: INSTITUT PRO TESTOVÁNI A CERTIFIKACI, a. s (Czech Republic).
– https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=notification.html&ntf_id=320100&version_no=24.

UK MHRA: Borderline items: just how to inform if your item is a clinical gadget: New area included ‘Risk category of clinical tools’.
– https://www.gov.uk/guidance/borderline-products-how-to-tell-if-your-product-is-a-medical-device#risk-classification-of-medical-devices.
Swissmedic: Plan to approve FDA items in Switzerland.
– https://www.swiss-medtech.ch/en/news/politicians-decide-favour-patient-care.
– https://par-pcache.simplex.tv/subject/?themeColor=AA9E72&subjectID=58905&language=de.
Finland: Power power outages do not call for unique readiness steps from the customers of medications and also clinical gadgets.
– https://www.fimea.fi/web/en/-/power-blackouts-do-not-require-special-preparedness-measures-from-the-users-of-medicines-and-medical-devices.