On-Site Medical Devices Regulation (EU MDR) Training for Manufacturers
ANSWERED ON THIS PAGE:
- What do our employees need to know about the MDR to maintain compliance?
- How can we prepare to recertify to the MDR?
- Is there an efficient, cost-effective way to train our team on the MDR?
In May 2017, the European Union released the Medical Devices Regulation (MDR 2017/745/EU) to eventually replace the Medical Devices Directive and Active Implantable Medical Devices Directive. The MDR introduces numerous changes, including a shift from the pre-approval stage to more of a life-cycle approach. It also incorporates a variety of European guidance documents (MEDDEVs) into the regulation and emphasizes the importance of Post-Market Surveillance (PMS), clinical data, clinical evaluations, and Post-Market Clinical Follow-up (PMCF).
MDR compliance presents many new challenges to medical device manufacturers. Our in-depth MDR training is designed to help you and your team prepare for these challenges and transition smoothly to the MDR.
What your team will learn in this two-day training class on the European MDR (2017/745/EU)
Our training provides your employees with a functional understanding of the MDR. During the training, your team will work with two fictional medical devices or two of your company’s products. You will learn:
- Scope of the MDR and a definition of a medical device
- Economic Operators – their roles and responsibilities
- Uploading data and maintaining compliance with EUDAMED
- UDI in Europe and how it compares with US FDA UDI requirements
- Classifying medical devices under the European MDR
- Conformity assessment procedures and the role of Notified Bodies
- Safety and performance requirements
- Navigating standards under 2017/745/EU
- Clinical evaluations and “new rules” on adequacy of clinical data
- Clinical investigations and Clinical Research Organizations
- Post-Market Surveillance (PMS) and Post-Market Clinical Follow-up (PMCF)
- Vigilance requirements for Europe
- The role of the Personal Responsible for Regulatory Compliance (PRRC)
- Planning your transition to the MDR
This two-day training allows ample time for discussion after each module. At the end of the training, your team will feel comfortable providing answers to most MDR questions they receive in their daily work.
On-site EU MDR training with experienced medical device consultants
Our MDR training is an excellent value for companies training three or more employees at a time. The training is conducted at your facility by senior regulatory consultants who spend most of their time working with clients on MDR compliance - not jumping from city to city doing training. They are fully tuned in to the needs of the industry and understand practical aspects of meeting the regulations. A private, on-site venue allows your employees to ask questions related to their specific situations--something they cannot do comfortably in local hotel-based group classes that may include competitors. Plus, on-site training ensures that every employee receives consistent information for a fixed price, regardless of how many employees attend.
The MDR will be here before you know it. Please contact us for more information or a proposal for intensive EU MDR training conducted at your facility.
Common MDR training questions
Who should attend the MDR training?
The training is appropriate for all staff involved in regulatory activities up to upper management. A basic level of understanding of the current European Medical Devices Directive 93/42/EEC is recommended, but the training can be adapted if required.
Do employees receive a certificate after the training is completed?
Yes, we will issue each attendee a signed certificate within one week after the training. The employee must attend the entire session to qualify for a certificate.
What is the daily training schedule?
Training generally runs for 8 hours each day and includes a one (1) hour break for lunch and two (2) smaller breaks in the morning and afternoon. However, this can be changed to suit your specific business needs.