Training information

Category Medical Device and Compliance

IMPLEMENTING NEW EU MEDICAL DEVICES REGULATORY FRAMEWORK

Steps for certification under the new Regulations (MDR and IVDR)

IMPLEMENTING NEW EU MEDICAL DEVICES REGULATORY FRAMEWORK

Date: 5-6 October 2017 | 9.00-18.00

Location: Hotel H10 Catalunya Plaza Boutique - Barcelona

Language: English

Lecturer/s: Lidia Canovas and Dominique Monferrer

*Registration fee: € 1570,00

*Early bird: 07/09/2017


Registration

Brochure

Why take this course?

The New Medical Devices Regulations (MDR and IVDR) entail a new approach on the product development and lifecycle maintenance as well as on the milestones for product recertification (i. e. Technical File Update), for both Medical Devices and In Vitro Diagnostic products.
The course has been designed to get an advanced introduction and insight in the new challenging environment of EU regulatory legislation for medical devices and practical advices for working in the future. In addition, an update on the latest developments and impact on the daily activities of a medical devices company will be provided.
After the training, participants should be able to avoid pitfalls and compliance issues with the latest European regulations on Medical Devices and optimize the effectiveness of the Vigilance and Market Surveillance system.

What will we do in the workshop?

This is a 2 -day interactive training where presentation alternate with practical sessions, discussion of business cases and audience questions.

Who is the course for?

This course is for anyone who deal with Medical Devices working in the following departments:

  • Regulatory
  • Quality Assurance
  • Vigilance
  • Compliance
  • Medical Affairs
  • Clinical Operations

Programme

New regulatory Framework and Development Milestones for Recertification

1. New Regulatory Framework (MDR – IVDR)
a. New Regulations presentation
b. New Regulation most important changes
c. Upcoming challenges
2. Implementation Strategy – Recertification plan
Discussion – Q&A

3. Development milestones, steps to MDR certification
a. Classification and scope of the New MD Regulation
b. Routes of Conformity
Practical Cases – Q&A

Technical File Updates; placing on the market and maintenance of devices

4. Technical File Updates for MDR compliance
a. Updated Technical File Compilation (Part I)
b. Updated Technical File Compilation (Part II)
Discussion – Q&A

Impact into In Vitro Diagnostic products

5. In Vitro Diagnostic Regulations impact
a. Classification and scope of the New IVD Regulation
b. Updated Technical File Compilation
Discussion and Practical Cases – Q&A
Closing remarks – Q&A

Technical File Updates; placing on the market and maintenance of devices

6. Operators Requirements (MAID)
7. Notified Bodies Requirements and Assessment
Discussion and Practical Cases – Q&A

At the end of the training you will be able to:

Understand the complete New Medical Devices Regulations, the increased requirements and upcoming challenges to ensure compliance in the future.

Lecturer’s bio

Lidia Canovas, Director of Regulatory Affairs, Asphalion S.L.
Lidia has a Pharmacy and MBA degree. She has fifteen years overall experience in pharmaceutical industry, ten years as Regulatory Affairs Director and four years as Vice-Director for Research and Development. She has been working at Asphalion for ten years as General Manager and Director of Regulatory Affairs. As director of Regulatory Affairs at Asphalion, Lidia is responsible for the overall quality of the Regulatory and Scientific services that Asphalion provides to a large number of international and national clients.

Dominique Monferrer, Scientific & Regulatory Affairs Associate Director, Asphalion S.L.
Dominique has a Degree in Human Biology and a PhD in Protein X-Ray Crystallography. After 6 years in academic research, she joined Asphalion in 2011, where she has been working in different aspects of regulatory affairs. As Regulatory Affairs Associate, she leads a team focused on strategy of new submissions and CMC writing for medicinal products, as well as development and registration of medical devices and in vitro diagnostics. In particular, her expertise in medical devices is based on numerous consultancy projects including the design of customized regulatory roadmaps, the definition of viability scenarios for borderline products and the assessment of the best regulatory strategy for CE marking and FDA clearance.