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Medical Device New – February 2023 Regulatory Update

#easymedicaldevice #medicaldevice #regulatorycompliance

— Annual review of tools based on the scientific Evaluation Consultation Procedure (CECP):

— Vote:

— Swiss– FAQ on Medical Devices:

– EU MDR Nando:
— Notified Bodies SLG Prüf und Zertifisierungs:
– EU IVDR Nando:

— UK MHRA raises UK analysis ability for In-Vitro analysis gadgets:

— EU Delegated instruction for exception for the lead as a thermal stabilizer in Polyvinyl Chloride utilized as the base product in sensing units utilized in in-vitro analysis clinical tools:

— EU change of the EU MDR and also IVDR:

■ Monir El Azzouzi Linkedin:
■ Twitter:
■ Pinterest:
■ Instagram:

— Q&A:

— MDCG 2023-1 Guidance on the wellness organization exception under Article 5( 5) of EU MDR as well as IVDR:

— Saudi Arabia: Guidance AI/ML Software based:

– Podcast episodes:

— General Secretariat:

— Leading Voices in Medtech:

— Training EU MDR 2017/745:

Right here is your Regulative Update for the month of February 2023. Inspect all the web links listed below

— EU checklist of Standard Fees for Notified Bodies:

► Social Media to comply with

— UK federal government feedback to the appointment on Medical Device Regulation:

— EU Coverage of MDR code:

— Proposal for expansion assessment: