EU Regulations

illustration of people with pencils in their hands writing on a large clipboard with the heading regulations on it - used by patient guard limited to discuss the topic of EU regulations and PRRC under article 15 in relation to medical devices and IVDS.

Person Responsible for Regulatory Compliance (PRRC)

Blog, EU Regulations, Patient Guard News /

Person Responsible for Regulatory Compliance (PRRC), is a requirement for medical device and IVD manufacturers and Authorised Representative. Article 15 of regulations EU 2017/745 (MDR) and EU 2017/746 (IVDR), define the legal requirements for a PRRC.

They state that each manufacturer and authorised representative (if applicable) must have at their disposal a PRRC, who has the necessary requisite qualifications and experience for regulatory compliance.

Person Responsible for Regulatory Compliance (PRRC) Read More »

Medical Devices Classification - This is an illustration of a hand under an x-ray. The hand shows the bones of the hand. This image is used by patient guard to demonstrate an example of a class IIb medical device.

Medical Device Classification EU

Blog, EU Regulations /

In the EU Medical Devices are categorised into 6 classes, these are Class I, Class Is (sterile), Class Im (measuring), Class IIa, Class IIb and Class III.  

Class I devices are considered to be of low risk, Class II devices as medium risk and Class III devices as high risk. 

Depending on the classification of device determines the regulatory conformity pathway that needs to be taken to gain compliance and allow manufacturers to place product on the EU market. 

Medical Device Classification EU Read More »

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