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Home > Medical Device made Easy Podcast > Medical Device News – December 2022 Regulatory Update


	Podcast:		Medical Device made Easy Podcast
	Episode:		Medical Device News – December 2022 Regulatory Update
	Category:		Business
	Duration:		00:00:00
	Publish Date:		2022-12-06 07:29:58
	Description:		HOT TOPICS Europe Common specifications for the groups of products without an intended medical purpose listed 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 groups of certain active products without an intended medical purpose https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=celex%3A32022R2347 Updated information pack for candidate EU reference laboratories published 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 Training December 12th until December 16th https://school.easymedicaldevice.com/product/gb UK MHRA: Borderline products: how to tell if your product is a medical device: New section added ‘Risk classification of medical devices’ 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 accept FDA products 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 blackouts do not require special preparedness measures from the users of medicines and medical devices https://www.fimea.fi/web/en/-/power-blackouts-do-not-require-special-preparedness-measures-from-the-users-of-medicines-and-medical-devices Rest of the world United States: 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 United States: MedSun Newsletter – November 2022 https://www.fda.gov/media/162771/download Canada: List of recognized standards for medical devices: 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 Interesting as ISO 13485:2016 is not included. Canada: November 8, 2022 updates to list of medical devices for mandatory shortage and discontinuation reporting 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 Bahrain: Reminder Regarding Deadline for Medical Devices and Supplies Authorized Representatives Registration https://www.nhra.bh/Media/Announcement/MediaHandler/ImageHandler/documents/Announcements/Announcement2022_Circular No. (35) 2022_To Medical Devices Importers and Suppliers_Deadline for Medical Devices Supplies Authorized Reps Registration_20221124.pdf If you are looking for an Authorized Representative or Importer in the European area, contact us at EO@easymedicaldevice.com PODCASTS: Episode 205: **Your Software/IVD clinical report is completely WRONG! https://podcast.easymedicaldevice.com/205/ Episode 206: **Regulatory Pathway: How to reach the US market? [510k exempt] https://podcast.easymedicaldevice.com/206-2/ Episode 207: **Why Risk Management is important to Medical Device development? https://podcast.easymedicaldevice.com/207-2/ Episode 208: **How to choose the best Sterilization Method for Medical Devices? https://podcast.easymedicaldevice.com/208-2/ The post Medical Device News – December 2022 Regulatory Update appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
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