Medical Devices (includes IVDs)

Lessons Learned From First MDR/IVDR Certifications

Tuesday, September 15, 2020

9:35 AM – 10:30 AM EDT

Moderator(s)

Suzanne Elizabeth Halliday, MSc. D.Phil.

Head of Notified Body
BSI - ENTERPRISE

Slides

Speaker(s)

JB

Johnathon William Bis

Vice President Sales
BSI (London)
Erica Conway, PhD

Global Head - In Vitro Diagnostic Medical Devices
BSI (London)
Royth Philippp von Hahn, PhD

Senior Vice President of Medical Health Services (global)
TUV SUD Product Services

Applications to the MDR/IVDR are very prescriptive and submitting the correct information can ensure that no applications are refused. This presentation will start by explaining the requirements of Annex IX Clause 2.1.
One of the most crucial aspects of the application is a list of the devices to be covered by the CE certificates. Ensuring complete classification rationales will avoid the need for the classification dispute process described by Article 51/Article 47.

Although the MDR indicates there are four classes of device, there are actually eleven different conformity assessment pathways that could be followed. This presentation will explain why reading Annexes IX, X and IX are not enough.

Finally this presentation will show some example CE certificates that meet the requirements of Annex XII and all of EUDAMEDs requirements.

Learning Objectives:

Upon completion, participants will be able to classify or understand classification disputes in the EU. After classification the route of conformity can be chosen.
After classification and choosing Annex IX, X or XI, conformity assessment is divided into QMS assessment and Product Verification (Technical Documentation Review, Type Exam, Verification). Lessons learned to be shared.
After obtaining certificates, participants will learn what post market surveillance activities occur. Lessons learned on certificate format facilitating post-market requirements to be shared.