Are your medical devices compliant with EU MDR requirements? What steps we need to follow

steps to achieve EU MDR (2017/745) compliance:

Determine your device classification (Class I, IIa, IIb, or III)

Implement a Quality Management System (QMS) aligned with ISO 13485

Conduct a clinical evaluation and gather supporting data

Prepare technical documentation (as per Annex II & III of EU MDR)

Appoint a Person Responsible for Regulatory Compliance (PRRC)

Engage a Notified Body (for Class Is, Im, Ir, IIa, IIb, and III devices)

Ensure labeling and Unique Device Identifi

Would you be interested to Invest in CGM system production ? If yes, please read my articles on my profile page.

Curious to know what your stars or kundli say about you? Get your Free Kundali Online by Dr. Vinay Bajrangi, the most searched Vedic Astrologer. Understand your destiny, career, marriage, health prediction, and future with accurate predictions and simple remedies. Visit his website now and check your free Kundali today!

Following key steps, including product classification, conformity assessment, technical documentation preparation, clinical evaluation, registration with EUDAMED, and ongoing post-market surveillance.

If you're uncertain about the readiness of your EU MDR documentation, this article provides an overview of the essential steps to ensure you're on track.

Ensure compliance by classifying devices correctly, maintaining technical documentation, conducting clinical evaluations, and obtaining CE marking. Regular audits and post-market surveillance are also mandatory.