MDR 2017/745 course
Course description
This 1 day training course gives participants an in-depth knowledge of MDR 2017/745 requirements and its application.
It guides organisations through the regulatory requirements all type of devices, active or non-active sterile devices.
It is explaining how to comply with EU MDR requirements and explains how businesses can guarantee safety claims of medical devices to keep the CE mark on their device.
Learning objectives / course outcomes
By the end of the course, participants will be able to:
Identify the EU MDR requirements and how to transition from MDD:
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Explain how to define the classification of the device
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Which annex I requirement is applicable
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Define the structure and content of your technical file
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Define the role and responsibilities of PRRC
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Define the clinical evaluation activities and their frequency
Who is the course suitable for?
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Regulatory quality managers and personnel
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Design and development managers and personnel
Course outline
I- Introduction
a. Objectives of the course
b. Structure
c. Introduction and international context of application
II- Core definitions, qualifying medical devices, and applying Annex VIII classification rules (Class I, IIa, IIb, III).
a. Requirements
b. Content of the description of the product
c. Classification of the product
d. declaration of conformity
III- Navigating Annex I requirements, risk management integration (ISO 14971), and technical documentation structure (Annex II & III).
a. Identification of the annex I requirements applicable
b. How to link to the risk management documentation
c. Structure of the technical documentation
d. What to provide if you device is sterile
e. What to provide if your device is a software
f. Marketing documentation
IV- Clinical Evaluation Plans & Reports (CEP/CER), clinical data requirements, equivalence criteria, and PMCF planning.
a. PMS plan
b. PMCF plan
c. PMCF report
d. Clinical evaluation plan
e. Clinical evaluation report
f. PSUR plan and report
V- Manufacturer, Importer, Distributor, and Authorized Rep duties; Role of the PRRC (Article 15);
a. Roles, responsibilities and agreements
b. role and responsibilities of PRRC
VI- UDI system and EUDAMED registration.
a. How to define UDI and to document it
b. Registration in Eudamed (economic operator and device)
VII- Notified Body selection, conformity assessment routes
a. How to check if the notified body is qualified for your device
b. How to choose the conformity assessment route
VIII- Conclusion
Prerequisites
Participants should have a basic knowledge of:
- quality management systems and/or
- the medical device industry
What format does the training take?
MDSSPRO uses interactive teaching techniques, keeping the course varied and stimulating through exercises, working applications and case studies. Experienced and knowledgeable industry-leading tutors ensure individuals stay engaged throughout the course and that the learning objectives are met.
The course can be run online or onsite at company offices.
MDSSPRO’s online training course is powered through a Performant Software platform. Online tutors are available throughout the length of the course offering full support to course participants, answering questions, offering advice and explaining course material as required.
Price
We are providing online training course for £500 per person on our platform https://mdsspro.talentlms.com/index. The content is available for 3 months after registration.
A certificate is delivered after completion of the training. Want to start now? Press the button
On site training is tailored by on your needs. For more details contact office.mdsspro@gmail.com