Medical Device News – December 2022 Regulatory Update

Medical Device made Easy Podcast

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 [e-mail]

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