. Short intro of SG as NB
. Technical documentation Requirements
. Main issue met during assessment
. Concrete example on Software
. Concrete example on legacy devices
. How to avoid issue during your Technical documentation assessment

Summary: This presentation shall give you an overview on how technical documentation assessment are conducted by SGS as Notified Body including the main issues identified by our assessors and how they can be avoid to get your MDR Certification.

The EU MDR 2017/745 was subject to many amendments since its official publication in 2017. Most of them were done to address the implications of this complex regulation on the various economic operators, notified bodies, authorities and most importantly on the access of patients to safe and well-performing medical devices. During this presentation, you will be able to hear a story about the challenges and opportunities during a conformity assessment process. The presentation will conclude with some recommendations towards achieving lean and less burdensome MDR Certification.

With the implementation of the IVDR, many new requirements are introduced and it remains challenging what is expected from a manufacturer. The latest IVDR extension ((EU) 2024/1860) has provided more time for IVDD manufacturers to prepare for the IVDR. However, to make use of this extension, certain requirements need to be met. This presentation will focus on what needs to be in compliance, to make sure your IVDD device can make use of the extension. One of these requirements is a post-market surveillance (PMS) process according to the IVDR. This will be discussed in more detail, covering the major differences between the IVDD and IVDR PMS process, and more information on the IVDR requirements.

– difference between distributor and importer under MDR / IVDR
– obligations of distributor and importer under MDR / IVDR
– practical aspects to keep the obligations
– red line between distributor / importer and manufacturer 

As indicated in Article 16(2) of MDR and IVDR, importers/distributors who conduct relabelling and/or repackaging activities on devices already placed on the EU market shall submit an Article 16(4) certificate to the Competent Authority of the EU Member State in which they plan to make the modified device available. Importers/distributors who require an Art 16(4) Certificate should apply for the Article 16(4) Certification Scheme with a Notified Body that is designated for the types of devices that are subject to relabelling and/or repackaging. The importer/distributor shall ensure they have in place a Quality Management System that includes procedures which ensure that they meet the requirements described in Art 16(3). The presentation at the EAAR Conference will provide information on BSI’s Article 16(4) certification Scheme and its Conformity Assessment and Certification Process Steps.

Difficulties encountered, lessons learned, and improvements achieved in the MDR implementation process. The presentation will focus on the key strategies and steps taken to ensure compliance with the MDR requirements to overcome challenges and achieve successful market authorization under the EU regulatory framework.