The Medical Device Coordination Group (MDCG) has recently published very helpful documents.
The MDCG, also known as the Medical Device Coordination Group, is an expert body required by the MDR and IVDR.
We would like to present two of the documents in more detail:
The infographicIs your Software a Medical Deviceshows very clearly with simple words and supported by pictograms how I can determine whether my software falls within the scope of the MDR (Medical Device Regulationor IVDR (In Vitro Diagnostics Medical Devices.
The MDCG 2021-3 document ‘Questions and Answers on Custom-Made Devices’ answers questions that have arisen about custom-made devices and contains considerations for adaptable and patient-adapted medical devices according to MDR.
Right at the beginning, the document starts with the basic definition of a custom-made device. Customised series products are often mistakenly regarded as custom-made devices. Helpful examples are given to make this distinction clearer.
The frequently asked question of whether components or materials of customised products can be placed on the market as MDR-compliant medical devices separately from the actual medical device is addressed, as is the handling of the increasingly established field of 3D printed products. Finally, the obligations that manufacturers of custom-made products have to take into account under the MDR are summarised once again. Take a look at this very helpful guideline, find further answers to your questions and discuss with us which tasks need to be completed.
You can find a complete overview of the publications on the website of the MDCG.
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