What I wish I knew before I started with the MDR

What is the MDR?

The Medical Device Regulation (“MDR”) is a EU Regulation that lays down rules concerning the placing on the European Economic Area (“EEA”) market, making available on the EEA market or putting into service of medical devices for human use and accessories for such devices in the EU. It also applies to

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What is a medical device?

If you are wondering whether you are dealing with a medical device, you need to refer to the definition in Article 2(1) of the MDR. For various reasons (business case, compliance, planning the product launch), it is important to determine in an early stage of the product development process whether

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Is there an overview of everything needed?

To become or remain competitive, companies must constantly innovate by developing new products. Unfortunately, many development projects fail prematurely, it is important to use a systematic and strategic product development process, to reduce ineffective deployment of resources. Product development projects have many types of risks. In terms of development time

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Where to start?

An important starting point within the development project is the business case. Depending on the business activities, the scope of the quality management system (QMS) is determined (by the Quality Assurance Manager). Both the QMS and product development must have a risk-based control mechanism. With that, work processes for the

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What happens after starting?

Most mandatory documents can only be finalized at the end of the development project. However, it is not wise to draw up all documents at the end of the development project. As a result, not only is a lot of time lost – after all, the product is ready, but

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How much time and money does this whole story cost?

When the technical documentation (TD) contains all mandatory documents and the QMS meets the requirements, the medical device can be offered for CE certification to the Notified Body. Unfortunately, applying for a CE certification has a very long lead time. It starts with contacting a Notified Body that is allowed

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How can I build up knowledge?

Like any product placed on the market, medical devices must also comply with laws and regulations. It can be quite difficult to find out exactly which laws and regulations the product must comply with. Unfortunately, the Notified Body is not going to help you with this either. You have to

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Where can I find help?

There are many tasks that must be performed to comply with the MDR before a medical device can be placed on the market or put into service. A non-exhaustive list of these tasks include: starting with qualification and classification, identifying standards and recording evidence, establishing and maintaining contact with the

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How do I approach clinical evaluation including contact with hospitals?

A clinical evaluation provides clinical evidence that the medical device performs as claimed by the manufacturer and that it is safe to be used in clinical setting. Sometimes, especially when clinical investigation is needed, the clinical evaluation requires collaboration with healthcare institutions. What does clinical evaluation entail? What a clinical

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What does contact with a Notified Body look like?

Before a manufacturer can place a medical device on the European Economic Area (“EEA”) market or put the medical device into service, a conformity assessment must be performed with a positive result. Depending on the applicable conformity assessment procedure, a designated Notified Body must be involved in this procedure. Please

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