Why is the CE marking required?

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What does the entry into force of IVDR 2017/746 entail for manufacturers of in vitro diagnostic Medical Devices?

The complex process of developing IVDs could become difficult and take a long time for most device manufacturers. IVD manufacturers are invited to act on time in order to be in compliance with the entry into force of the new Regulation. Among the most important innovations, we can mention: changes to devices classification (many IVDs [...]

2018-05-18T17:10:54+02:00May 18th, 2018|FAQ, Why is the CE marking required?|

When do I have to appoint an Authorized Representative?

If a device manufacturer is established outside the European Union, it’s necessary to appoint an Authorized Representative by a written power of attorney. The Authorized Representative must be a physical or legal subject established in one of the EU countries, who represents the foreign manufacturer against the European competent Authorities. The Authorized Representative name and [...]

2017-07-19T09:08:47+02:00July 19th, 2017|FAQ, Why is the CE marking required?|

How can I establish a medical device risk class ?

Medical Devices are classified according to their complexity and potential risk for the patient. In accordance with the current Regulation, four risk classes were established: I, IIa, IIb and III. The intended use the manufacturer established for the device, the device invasiveness, its energy source dependence and the time duration with the human body are [...]

2017-07-19T09:05:38+02:00July 19th, 2017|FAQ, Why is the CE marking required?|

What is the OBL contract?

The term Own Brand Labeling (OBL) refers to the particular procedure that a Medical Devices manufacturer should follow when marketing devices bearing a CE marking in its own name (“me too” device). The European Regulation considers the OBL manufacturer as the legal manufacturer even when he is not involved in the device manufacturing. Consequently, the [...]

2017-07-18T11:43:07+02:00July 18th, 2017|FAQ, Why is the CE marking required?|
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