Custom-made devices in the MDR

Custom-made devices MDR

A custom-made device in MedTech is a product prescribed to a patient by an authorized person, such as a physician. This product, by prescription, is manufactured exclusively for the respective person. Mass products with adaptions adjusted to fit the user’s needs are not considered as custom-made devices. Custom-made devices were already part of the Medical […]

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MDR – Market Entry Consideration for MedTech Products

Market Entry Consideration

What requirements must a product fulfill before it can ultimately be sold in the EU? This question is answered in the second chapter of the Medical Device Regulation (MDR). It includes information on placing products on the market, commissioning, and the role of authorized representatives. The responsibility for this lies with manufacturers, importers, and distributors. […]

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Notified Bodies and Certificates

Benannte Stellen

A Notified Body is a government-supervised organization designated by a member state of the European Union to test the suitability of various products before they are placed on the market. The European Commission also maintains a database of Notified Bodies called Nando (New Approach Notified and Designated Organisations). In medical technology, they are also responsible […]

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IVDR for Manufacturers

In Vitro Diagnostica Regulation (IVDR)

At first glance, the general differences between the In Vitro Diagnostic Directive (IVDD) and the In Vitro Diagnostic Regulation (IVDR) are not particularly significant. Regulations of the IVDD continue to exist, so to speak, but they are supplemented by additional regulations, resulting in the IVDR. For example, the obligations of economic operators, i.e., manufacturers, authorized […]

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Costs of a EUDAMED Solution


Although it still seems far away, the date of the EUDAMED deadline is getting closer and closer. However, like on Christmas, you are caught off guard by how sudden the deadline comes around the corner. Good preparation is essential to face the deadline calmly. After all, the Medical Device Regulation (MDR) and especially the new […]

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Outsourcing of EUDAMED User Roles

Outsourcing EUDAMED

Due to the Medical Device Regulation (MDR), digitalization of the medical technology industry is taking place. EUDAMED plays a instrumental role in this. Among other things, it intends to ensure the tracking of medical devices. However, it also entails a host of new tasks and obligations. Obligations will have to be taken on by a […]

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EUDAMED Actor Roles

EUDAMED Actor Roles

The EUDAMED Actor Roles are part of the Actor Registration Module. It is the first of the six modules to be made available to the public. Each person or actor must register here before using EUDAMED. The European Union defines an actor as: A natural or legal person (organization) with a specific role that must […]

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