MedDev Day

With new regulations on IVDR and MDR, the regulatory system for medical devices has moved to a new level. The challenges differ for the industry, notified bodies, and competent authorities.

From a competent authority point of view Thomas’ presentation will address:

• The challenges seen from Competent Authorities in Europe
• Joint initiatives to improve the new regulatory system
• Market adjustment as a consequence of the new regulation
• Recent developments in Europe and future challenges

Under the European Commission website, a descriptive text under the Medical Devices Regulations reads as follows: “The new Regulations will create a robust, transparent, and sustainable regulatory framework, recognised internationally, that improves clinical safety and creates fair market access for manufacturers and healthcare professionals.”

Thus said, what is the status of implementation of these new regulations? Have any of these future visions already been achieved?

In this session, we will presenting last-minute updates from the MedTechEurope.

This presentation will focus on the notified capacity, will analyse the root causes and discuss the current state of play.

The relevant action points in the MDCG Position Paper 2022-14 “Transition to the MDR and IVDR
Notified body capacity and availability of medical devices and IVDs”, which was published in August 2022, will be discussed as well.

MED-EL is an Austrian manufacturer o class III, high risk devices. As a high risk medical medical device manufacturer based in the EU, we purposely determined an early adoption strategy to MDR, submitting our first MDR files and undergoing our initial MDR QMS audit in 2019. Consequently, we were among the very first to receive MDR certification in March 2020 for our Class III implantable systems and associated lower risk devices. Does this mean that we are done?

In this presentation I would like to share our learnings and challenges as we continue to transit the unpredictable and ever surprising MDR grace(less) period.

The EU MDR 2017/745 introduces new or updated consultation requirements during special conformity assessment processes. These consultations are adding complexity to the introduction of the regulation and require the involvement of designated authorities or EMA or the newly established EU expert panel to support the final certification decision of notified bodies.

During this session we will present examples of these critical consultation processes and share the initial learnings with regards to clinical evaluation consultation procedure, voluntary expert panel consultation and communications with medicinal agencies for the re-consultation of device drug combination products.

The presentation will review a manufacturer’s experience on navigating the transfer from MDD to MDR.

It focusses on requirements for legacy devices during the extended transition and the process of remediation of MDD to MDR.

Practical considerations and lesson learned will be given, as as implications for portfolio management.

With the gradual implementation of the EU MDR into reality, we slowly start seeing clarity in the actual expectations the notified bodies have towards the content of the medical device technical documentation. Some of the guidance is general, some is coming in second wave via harmonization between notified bodies, and some are notified bodies specific.

This presentation will help you maneuver these elements and clarify how you best prepare and ensure sufficient readiness for your documentation to withstand the scrutiny of the new notified bodies eyes.

How to go from gap assessment to reality; how to deal with the back and forth between various documents that need to be updated, but influence each other on claims, risks, clinical benefit etc. Strategies to include mock audits and mock dossier reviews.

The session will include some best practices as well as discussions with the audience to get all helpful insights shared between participants.

Moderated by Bassil Akra, Chief Executive Officer at AKRA TEAM GmbH

The perfect opportunity to discuss key issues with key industry experts.

Are you seeking assistance from a Medical Writer expert to address your questions and concerns about the State-of-the-Art of your device?

Secure a half-an-hour meeting with one of our Medical Writers by sending a request through ilaria.butta@lsacademy.com Katharina Friedrich and Laura C Collada Ali will be delighted to address your questions or concerns.