Medical Device News – December 2022 Regulatory Update

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/