Medical Device Regulations

Learn more about how to align with the new requirements of the EU-MDR (2017/745)

TRAINING

European Medical Device Regulation (EU-MDR 2017/745)

The new regulation on medical products, the Medical Device Regulation (MDR) 2017/745 (MDR), which replaces previous guidelines Medical Device Directive (MDD) 93/42/EEC and Active Implantable Medical Devices (AIMD) 90/385/EEC, has entered into force as from 2017. All manufacturers of Class I to III medical devices must familiarize themselves with the new requirements as soon as possible. The regulation has far-reaching implications and affects all classes of medical products

The EU-MDR brings about many changes, including many definitions, reclassifications, new conformity assessment routes, new Notified Body designations, and more. Stricter requirements on the safety of ingredients, on clinical evidence, and on consistency in regulatory compliance. Much more detailed in the essential principles, and above all: no grandfathering!

 

MEDICAL DEVICE REGULATION

All Medical Device Regulation trainings

Fundaments of the EU-MDR

Do you need to know more than the basics of the MDR? Take the 2-day course as there are a lot of changes. Build a solid foundation to ensure compliance.

MDD to MDR Conversion training

Understand the regulatory impact of remediation, retire, and transition of your product portfolio (portfolio rationalization). Transition timelines and strategy options.

MDR - PMS/PMCF

Learn in a practical way to look at PMS, understand the options for compliance.

MDR - Clinical Investigation


How to deal with clinical requirements in the MDR. The start point is your current intended use. What do you claim, or want to claim, how is this related to risk management, and how do you know if your current data is sufficient?

MDR - Economic Operator/ Supply Chain

How to establish, monitor and maintain the mutual agreements of manufacturers with the other economic operators and suppliers/subcontractors.

MDR/IVDR - How to write a technical file

This training focusses on practical guidance to fulfil the technical documentation requirements in the EU-MDR.

PRRC

The MDR and IVDR require that manufacturers and Authorized representatives have a person responsible for regulatory compliance. Qserve organizes training for persons that will be appointed by manufacturers or Authorized Representatives as PRRC.

MDR Labelling and UDI

The current requirements for labelling, unique device identification and product information / instruction for use of medical devices 

MDR Transition

It will highlight timelines, resources, NoBo approach and the top 10 changes for technical documentation. Guidance on how to implement the gap assessments, provide details on product portfolio review and on determining the impact of the regulation.

How can we help you? Contact us