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CE marking

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Guest user Created:   Nov 04, 2020 Last commented:   Nov 05, 2020

CE marking

My question is about why companies are allowed to market/sell products before receiving a CE mark approval. In articles I have read it seems that CE marking is a requirement for selling medical devices in Europe however I am looking at a couple of companies that are selling without a CE mark, what is the reason for this? Also if companies do not need a CE mark approval then what is the benefit of going through the process of getting one?

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ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

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Kristina Zvonar Brkić Nov 05, 2020

In the EU market, companies are not allowed to sell medical devices without a CE mark certificate if the medical devices are classified as class Is, Im, II1, IIb, or III. For medical devices that are classified as a class, you do not need to have a CE mark certificate; a Declaration of conformity from the manufacturer is enough in that case. 

In the case of class I medical devices, manufacturers need to register it in National regulatory authority and they need to issue a Registration notice.

All medical devices that want to be on the EU market must be in compliance with the Medical device directive (MDD 93/42/EEC) or Medical device regulation (MDR 2017/745), no matter the classification. In Article 1 of the MDR is stated: This Regulation lays down rules concerning the placing on the market, making available on the market or putting into service of medical devices for human use and accessories for such devices in the Union. This Regulation also applies to clinical investigations concerning such medical devices and accessories conducted in the Union.

For more information, please see:

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Nov 04, 2020

Nov 05, 2020