Collect your product data now

collecting product data medical devices

The extension of the MDR transition periods came at the right time for many companies. A survey by the Medical Device Coordination Group (MDCG) in April 2022 found that a total of 85% of medical devices certified under the Medical Device Directive (MDD) and Active Implantable Medical Devices Directive (AIMDD) are not yet certified for […]

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MDR Transition Periods Extension

MDR transition period extension

On January 06, 2023, the European Commission (EC) published a proposal for the extension of the MDR (Medical Device Regulation) transition periods. This proposal was already adopted on February 16, bringing the extension into force. The obligation of medical device manufacturers to be MDR-compliant was thereby postponed several years into the future. reason for this […]

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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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