CEMD
Impact of the new European regulation on medical devices on clinical data
Impact of the new European regulation on medical devices on clinical data
Training distributed with our partner Neomed Services.
Objectives :
To raise awareness of the teams in charge of activities involving clinical evaluation and clinical studies (CE marking, PMCF,…) of medical devices to the impact of new regulations (MDR 2017/745, ISO 14155, MEDDEV 2.7/1 rev4).
This training will allow you to have a broad understanding of the new regulatory context related to the implementation of clinical investigations and the management of the data involved. A perspective on the current regulatory context in France will also allow you to better define your clinical development strategies.
Level of trainees :
This training is addressed to engineers, project managers and managers whose activity leads to set up clinical investigations and/or carry out clinical evaluations of DM (quality assurance, regulatory affairs…).
No prerequisite required.
Duration and location :
- Duration : 7 hours over 1 day
- Location :Soladis training center in Paris or Lyon (to consult the calendar, click on “Sign up”) or directly in your office (minimum of 4 people)
Training fee :
- In Soladis office : 850€ HT per trainee
- Other : Contact us for an offer adapted to your company.
Pedagogical Manager : Yann FARDINI
“The evolution of European regulations imposes new requirements in terms of clinical evaluation, production of clinical data and their integration into the life cycle of present and future medical devices. This constitutes a real change and new constraints generating questions for many actors in the Life Science field. We will discuss this during this training to give you the keys to understanding and promote the proper development of your DM. “
The training will be given by two consultant trainers who share their expertise in clinical evaluation and clinical investigation.
Regarding inter-company trainings, the following program will be delivered:
IMPACT OF THE REGULATION ON CLINICAL EVALUATION
- Background and general information
- Focus on Article 61 and Annex XIV – Part A
- Introduction to the summary of safety characteristics and clinical performance.
IMPACT OF THE REGULATION ON CLINICAL INVESTIGATION
- Presentation of the general requirements for clinical investigations
- Focus on Annex XV
- How to apply for and conduct a clinical investigation according to the Regulation
- Confrontation of the requirements of the Regulation with the current modalities of implementation of clinical investigation in France: study documents and procedure according to the Jardé Law
CLINICAL EVALUATION ACCORDING TO MEDDEV 2.7/1 REV4
- Context/General information
- Scope of the clinical evaluation (stage 0)
- Clinical history, current knowledge, state of the art (Stage 1)
- Identification of clinical data (Stage 1)
- Evaluation of clinical data (rotation 2)
- Analysis of clinical data (rotation 3)
- Clinical evaluation report (stage 4)
IMPACT OF THE REGULATION ON POST-MARKET CLINICAL FOLLOW-UP
- Focus on Annex XIV – Part B
- Periodic safety update report
- How to set up a SCAC study according to the Regulation
- Putting into perspective the requirements of the Regulation with the modalities of setting up a SCAC study in France according to the Jardé Law
In intra-company, this program will be modulated and adapted to your issues. Discussion time around questions specific to your product and your context can also be scheduled during this day.
EXAMPLES OF QUESTION AND ANSWER SESSIONS AND DISCUSSION ON CASE STUDIES :
- Clinical strategy to be adopted according to the products in development or on the market
- The issue of equivalence in clinical evaluation
- Answers to various practical questions
Soladis - France (headquarter)
6-8 rue Bellecombe
69006 LYON - FRANCE
Tél: +33(0)4.72.83.86.70
Soladis GmbH - Switzerland
Lange Gasse 15
CH-4052 Basel
Phone: +41(0)58.258.15.80
Soladis Inc. - USA
185 Alewife Brook Pkwy, Unit 210
Cambridge, MA 02138-1100
Phone: (+1)857.675.1189
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