The February 2022 Regulatory Update contains a lot of information that may help you to maintain your team up-to-date with the new requirements.

► Agenda:
- IVDR news on transition, Expert Panel, and Finland reminder
- Clinical Trial Regulation in EU and UK
- Training EU MDR 2017/745
- EUDAMED Certificate module
- EU Reinforced role for EMA on medical device and medicinal product shortage
- Harmonized Standards
- Annex XVI Draft
- Switzerland Good Reprocessing Practices
- Re-registration within MHRA
- Bahrain medical device that doesn’t need registration
- Newsltetter: FDA Medsun and Japan PMDA
- MDCG guideline
- Notified Body situation
- EMD Podcast

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LINKS

► IVDR
■ IVDR: (EU) 2022/112 : [ Ссылка ]
■ Expert Panel: Performance Evaluation: [ Ссылка ]
■ Finland – FIMEA: At home-test Covid 19: [ Ссылка ]

► Clinical
■ Regulatory harmonization of clinical trials in the EU: Clinical Trials Regulation to enter into application and new Clinical Trials Information System to be launched [ Ссылка ]
■ UK: Consultation on proposals for legislative changes for clinical trials [ Ссылка ]

► Training
■ Green Belt Certification Program Edition 16: February 21st to February 25th: [ Ссылка ]

► Divers
■ EUDAMED Certificates module: [ Ссылка ]
■ Podcast episode 111 with Leon Doorn: [ Ссылка ]
■ EU – REINFORCED ROLE FOR THE EUROPEAN MEDICINES AGENCY IN CRISIS PREPAREDNESS AND MANAGEMENT FOR MEDICINAL PRODUCTS AND MEDICAL DEVICES [ Ссылка ]
■ Harmonized Standards (New Webpage): [ Ссылка ]
■ European Commission: Draft Common Spec Annex XVI Consultation page: [ Ссылка ]
■ Switzerland: Good Reprocessing Practices: [ Ссылка ]
■ UK Responsible Person: Re-registration of MHRA accounts: [ Ссылка ]
■ Bahrain: Which Medical Device should not be registered: [ Ссылка ]%202022_T0%20All%20Medical%20Devices%20Companies%20and%20Healthcare%20Facilities_Cases%20that%20Will%20Not%20be%20Included%20in%20Medical%20Devices%20Regulation_20220119.pdf

► Newsletter
■ USA: Medsun Newsletter January 2022: [ Ссылка ]
■ PMDA Japan: [ Ссылка ]

► Guidance:
■ MDCG 2022-1: Notice to 3rd country manufacturers of SARS-CoV-2 in vitro diagnostic medical devices [ Ссылка ]
■ MDCG 2022-2 General principle of Clinical Evidence for IVDs: [ Ссылка ]

► NB:
■ ITALCERT SRL EU MDR: [ Ссылка ]

► PODCAST:
■ Episode 162: How to accelerate your laboratory test results? [ Ссылка ]
■ Episode 163: How to interview a QA RA Candidate? [ Ссылка ]
■ Episode 164: MDCG 2021-27: [ Ссылка ]

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► Social Media to follow

■ Monir El Azzouzi Linkedin: [ Ссылка ]
■ Twitter: [ Ссылка ]
■ Pinterest: [ Ссылка ]
■ Instagram: [ Ссылка ]

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