Procedure for clinical evaluation according to new MDR

[mohammed hammed]

Can someone help me get a procedure for clinical evaluation according to new MDR ?

 

[Philip B]

You need to write your own procedure related to your own devices and circumstances. Have a look at MEDDEV 2.7/1 rev. 4 and MDR Annex XIV, these will point you in the right direction.

 

[Bhavta]

Hi cpuld some please help me with a clinical evaluation procedure

 

[monoj mon]

Hi cpuld some please help me with a clinical evaluation procedure

Clinical evaluation plan

 

[Bhavta]

Good morning All, just a quick question, my company is currently in the process of obtaining the CE mark, we have a company registered in the UK. I just need some direction as to were adverse events are reported and the time frames as per EU regulation.

Thanks in advance for your help

 

[Philip B]

Good morning All, just a quick question, my company is currently in the process of obtaining the CE mark, we have a company registered in the UK. I just need some direction as to were adverse events are reported and the time frames as per EU regulation.

Thanks in advance for your help

You report adverse incidents to the MHRA. Their guidance document on reporting, including timeframes, is here: Medical devices: guidance for manufacturers on vigilance

HTH

 

[debbie gallagher]

Are you only selling in the UK?

 

[Bhavta]

no

 

[Bhavta]

What are the Exemptions from Reporting Adverse Events to the Regulatory Authority for CE?

 

[Philip B]

no

In that case you normally report to the CA where you are based (ie the MHRA in the UK) and the CA of the country where the incident took place.