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 Medical Device Regulation was officially published on May 5, 2017, and came into force on May 25, 2017. Currently approved medical device manufacturers had an initial three-year transition time to May 26, 2020, which was changed to May 26, 2021, to meet regulatory requirements. Click here to access the MDR on the Official Journal of the European Union.

The new EU MDR imposes strict demands on medical device manufacturers and the Notified Bodies who must involve in the approval process of medical devices other than self-declaration class I devices. 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 many changes to the EU Medical Device Directives, 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!

Get Trained on the Medical Device Regulations Today

Since a large number of medical devices will now require a Conformity Assessment Procedure based on the MDR requirements in order to be placed on the European market, it is important to start in time with the transition to the new requirements. You will need advanced preparation, Qserve could train you on all steps of the implementation of the MDR. 

More information

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.

General Introduction MDR

It will provide knowledge of the requirements of the regulations, including the requirements for technical documentation and quality system requirements.

QMS - Beyond the obvious aspects we already know

New and changed key concepts and requirements of the QMS discussed and reviewed and comparisons to business processes are made.

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