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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 »

Medical Devices Classification - This is an illustration of two contact lenses. This image is used by patient guard to represent an example of class IIa medical devices.

Medical Devices Classification UK

Blog, UK Regulations /

In the UK 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 UK market. 

Medical Devices Classification UK Read More »

In vitro diagnostic regulations (IVDR), patient guard is a leading IVD consultancy

IVD Directive Essential Requirements Checklist

Blog, Client Questions, USA Regulations /

The 8 Step Essential Requirement checklist for IVD Directive. The IVDR EU 2017/746 is responsible for governing the regulatory market access for in vitro diagnostic (IVDR) medical devices. It also includes the requirements for each device’s technical documentation. The information can vary based on the classification of the device, but it is always the main piece of evidence within the essential requirements.

IVD Directive Essential Requirements Checklist Read More »

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