Emergency Line: (002) 01061245741
Mon - Fri: 8.00am - 7.00pm

Get In Touch:

Get In Touch:

Regulation (EU) 2017/746 (IVDR): MDR IVDR Amendment Jan. 2023 

Introduction

Paragraph 3 Amendments

3a. Derogation and Conditions

3b. Placing Devices with Certificates

3c. Conformity Assessment Procedure

3d. Conditions for Placement

3e. Application of MDR Requirements

3f. Responsibilities of Notified Bodies

3g. Derogation for Class III Custom-made Implantable Devices

Paragraph 4 Replacement

Article 122 Amendments

Article 123 Amendments

Regulation (EU) 2017/746 Amendments

Article 110 Amendment

Article 112 Amendment

Conclusion

Prev post
Next post

Leave A Reply