MEDICAL DEVICES

Regulatory / Classification of DM / Pre-clinical & clinical evaluation procedure

Location
Online

Date

May 26th and 27th, 2021

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Format

Visioconferences

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Programme

26th May 2021 is an important date for all stakeholders in the medical device industry in Europe.
This date represents the date of application of the MDR: Medical Device Regulation (EU) 2017/745.

Initially scheduled for 26 May 2020, the European Commission decided to postpone this date by one year due to the COVID-19 health crisis.
26th May 2021 will also be the date on which we propose to meet you for the opening of the new A3P DM day.

This day will be divided into two half-days on 26 and 27 May 2021 in the morning in order to carry out this forum remotely (due to the health crisis):

The first half-day will be devoted to news related to this new regulation with a focus on feedback from VSEs/SMEs on their concrete implementation of the new regulation.

The second half-day will be more focused on the evaluation of medical devices and their performance and will end with a Q&A session with all the speakers of the 2 half-days.

As in the past two years, we look forward to seeing many of you at this event, even if the conditions are a bit special this time.

✻

Wednesday 26th May

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8.45 am
Notified Agencies & Assessment Procedures
GMED
to come...
9.00 am
Devices and substances: classification and impacts
Christophe MACRET - SNITEM
Devices and substances: classification and impacts Regulation (EU) 2017/745 brings new classification rules and strengthened requirements for devices composed of substances. Which devices may be affected? What future for devices placed on the market under Directive 93/42/EC? What impact on technical documentation?
09.30 am
Break
10.00 am
Importance d’une identification précise pour les dispositifs avec stérilisation terminale
Yann PUIGMAL - CHARLES RIVER
To come...
10.10 am
Implementation of the Regulation: feedback from DM Experts on SMEs and VSEs
Lam-Xé NOEL & Jean-François BIRON - DM EXPERTS
These feedbacks are the result of field feedbacks in relation to the concrete implementation of the regulation (EU 2017/745), between industrialists and the DM Experts network. They are classified by theme, will focus on the main difficulties encountered by economic operators in applying the new regulation. Our experience in applying the regulation has forced us to find concrete solutions that correspond to their structure and means. - Introduction: analysis methodology used by DM Experts - Feedback from experiences classified by theme / analysis of each issue and response from the various economic operators - Conclusions: strategic points to consider
10.40 am
Assess suitability for use
Julien ALDEGHERI - USECONCEPT
Usability of its medical device (which methods at which time for which benefit?).
11.10 am
End of the webinar
11H40

Thursday 27th May

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08.45 am
Pre-clinical evaluation & bioaccountability
Abdess NAJI - MATIERE & SANTE
Without calling into question the approach to biological risk assessment described in ISO10993-1, Regulation (EU) 2017/745 raises other well-known issues to be taken into account in the biological assessment, such as combination products, devices containing materials of biological origin, absorption, distribution, metabolism and excretion phenomena, information to be communicated in package leaflets and/or labels in relation to toxicological risk.
09.00 am
Clinical evaluation
GMED
to come...
09.30 am
Implementing MDR - a report from the machine room
Alexandre KENT - BBRAUN
The implementation of the MDR is a journey. From planning the first milestones to the steps leading up to 2023. Rich in experience so far.
10.00 am
Break
10.30 am
Partner Session
AMSONIC HAMO
to come...
10.40 am
Round Table Discussion
Q&A session with the speakers Feedback and sharing of good practices
11.10 am
End of the event
11.55 am
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♦ Speakers ♦

NOM & PRENOM / ENTREPRISE

Registration

Registration Form

Medical Device Webinar – May 26th & 27th

Practical Informations

Contact

Depending on your requirements and preferences, you can contact Natalina Semedo or Florian Canuto. :

Phone : +33 7 58 69 26 30 // +33 7 61 55 24 36
Fax : +33 (0)4 37 28 30 60
Email : nsemedo@a3pservices.com // fcanuto@a3pservices.com
Adress : A3P, 30 rue Pré-Gaudry – Lyon 69007
On-site : 30 rue Pré-Gaudry, à Lyon, du lundi au vendredi

Webinar Advices

We use TEAMS (Microsoft Office) or ZOOM software to deliver our events in digital format. These secure and free collaborative platforms allow you to follow and interact with our experts, guests and other participants in the best conditions. This software is compatible with all operating systems (Windows / IOS) and offers an online version compatible with all browsers (Internet Explorer, Chrome, Firefox, Safari, …).

Some companies, for security reasons, forbid the installation of the ZOOM application. No worries, you can join the webinar and follow the presentation directly from your browser. If you do not have any restrictions, we invite you to install the application for free on your computer.

In the event registration confirmation email, we will provide you with the link to access the session via the selected platform (TEAMS or ZOOM) that you will need to follow on the day.

We invite you to plan a quiet and comfortable place to follow the sessions in the best conditions. The A3P team is at your disposal to accompany you and to ensure the proper functioning of your remote system.