The Medical Devices Regulation (MDR) is the legislation detailing the requirements that manufacturers have to meet to place medical devices on the market in the European Union.

The Regulation will affect all medical device manufacturers, importers, distributors and EU Representatives. Subcontractors/suppliers will also be affected, as will manufacturers of some devices without a medical purpose (for example, devices used for esthetical body modification, contact lenses to change eye colour without correcting vision, etc.).

The MDR focusses on device safety and performance, emphasizing pre-market requirements, conformity assessment, quality management aspects, post-market-surveillance (PMS), transparency and traceability. The requirements will also affect (supplier) audits and governmental control, introduce new partners to interact with, and increase communication needs and obligations (e.g. contracts, reporting, documentation, and publication of information).

This course aims to offer guidance on implementation of the requirements stipulated in the MDR. It focusses on enabling you to draw up a clear concept or project plan, and how to integrate the requirements into your business and your documentation. Moreover, you should gain confidence and expertise to evaluate and implement more specific requirements on your own.

Course Aim

To help implement the requirements of European Medical Device Regulation (MDR) to obtain and maintain CE marks for your product. The CE mark gives access to a market with 500+ million people. Find out best practice for assembling Technical Documentation and QMS when placing Medical Devices (MD) on the European Union market. The course will also review the requirements of, and relationship between, the legal manufacturer, subcontractors/suppliers, notified bodies (e.g. auditing), and economic operators (importers, distributors, EU Representatives) according to their obligations by MDR.

How will I benefit?

This course will help you:

• Implement the requirements of the European Medical Devices Regulation
• Guide and support other people and partner organizations affected by MDR
• Set up and update required documentation
• Take the necessary steps for your organization to meet the MDR requirement
• Maintain compliance to MDR and other/future documents related to Medical Device legislation
• Systematically explore and implement more detailed and updated provisions (e.g. common specifications (CS), acts, standards)

What will I learn?

By the end of the course delegates will be able to:

• Evolve a strategy for regulatory compliance as stipulated by MDR
• Implement requirements concerning the following steps for Conformity Assessment:
  • Scope and applicability of MDR
  • EU risk classification criteria for medical devices to determine “Risk Class”
  • General Safety and Performance Requirements (GSPRs) as the basis for CE marking, including the use of standards
  • conformity assessment routes and their application based on risk class
  • self-certification, CE-certification by Notified bodies, involvement of authorities, scrutiny
  • ‘Declaration of Conformity’ and CE marking
• Fulfil Technical Documentation requirements, e.g. in:
  • putting together ‘Technical Documentation’
  • necessary control of outsourced activities and processes and roles of external partners (e.g. supplying and commercial)
  • instantiate the importance and role of clinical data
  • risk management, process validation and their regulatory significance
  • drawing up Instruction For Use, label and other information supplied with the device
  • consistency and validity of information and electronic data management
• Plan post-market activities required by MDR with respect to:
  • Risk Management and related planning
  • Post-Market Surveillance and Post-Market Follow-Up (PMCF)
  • periodic reports, Vigilance, ad-hoc reporting
  • regulatory responsibilities of all economic operators including communication with competent authorities, notified bodies, economic operators, customers etc.
  • Recall, Field Safety Corrective Actions (FSCA), Corrective And Preventative Action (CAPA)
  • regulatory relevance of change control to QMS, design and manufacturing
  • extent of readiness for audits/reviews/assessment
• Put into effect gained knowledge concerning implementation of MDR requirements into your organization, e.g. in projects for CE-marking

Who should attend?

The course is especially suitable for:

• RA, QM, and QA professionals who need to implement the MDR
• Personnel concerned with certification or active in projects for CE-marking
• Staff working for organizations that partner with Medical Device manufacturers e.g. as subcontractor, crucial supplier, OEM, Authorized representative, importer, distributor, auditee

Please note: This course will not cover implementation for In Vitro Diagnostics or concentrate on devices with specific requirements.

Duration

3 days

How will I learn?

Our high impact accelerated learning approach increases learning by improving knowledge retention and skill application. This course is activity-based, resulting in a deeper understanding of the material and a greater impact on job performance.

What will I gain?

On completion, you’ll be awarded an internationally recognized BSI Training Academy certificate.

Prerequisites

Participants must have a good understanding of the requirements in the MDR, which is conveyed by our 1 day Requirements course or our MDD to MDR transition course.

Participants should also have either experience with, or basic knowledge, of quality management systems for the medical device industry, or good understanding of European Medical Device legislation, or some experience in pre-or post-market activities within the EU.

Further information

This course does not convey the understanding of MDR requirements. Please refer to our 1-day-requirement of the MDR training course.

This course will focus on the overall implementation of the MDR, and not on specific devices.

Detailed course notes are provided.

Course Materials

Soft Copy: You will receive an email prior to the course with instructions on how to access the online Student Handbook, which can be viewed, downloaded or printed.

NOTE: Copies of the standards are not included in the class fee.

BSI will make reasonable efforts to have loaner copies available for use during the class, but students are encouraged to have their own copy. Soft copies of the digital loaner standard cannot be printed or downloaded.

Course Logistics

If your class is Live Online:

• Students need to connect to the class from any internet accessible location.
• Webcam and Microphone are REQUIRED.
• ALL course times shown are US EASTERN TIME.

If your class is In-person :

• You are encouraged to bring a laptop with you to class.
• Please bring a picture ID such as a driver's license, passport, or work badge to class for verification purposes.

*Session lengths could vary depending on amount of class discussion.

Related training

IVDR courses, and specific courses are available on clinical evaluation and risk management.

MDR 1 day course.

MDD to MDR transition course.