Converting SOP MDD to MDR Noob

Seekingknowledgee

Starting to get Involved
#1
Hello all,

I was handed over the job to convert SOP of MDD to MDR. It is solely on me. And I don’t have experience in MDR.

Can someone please post procedure for the conversion of SOP for beginners. I would really appreciate it. My job lies on this. Please help out.
 
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chris1price

Trusted Information Resource
#2
I would be surprised if anyone has a procedure that you describe, even more surprised if they would be applicable to your company and your products. I would recommend reading the MDR and guidance available both here and on-line. Then perform a gap analysis with your existing procedures. Use what you have learnt as the basis of the procedure you are looking for.
 

James

Involved In Discussions
#3
That's a 'how long is a piece of string' question... As Chris suggests its impossible for anyone to answer that. You may get some pointers if you post more information. What is your organisation's context? Do you manufacture devices? Do you run 13485? If so I expect your system will need to change in various ways to meet increased expectations of the MDR.
 

adir88

Starting to get Involved
#4
You would begin with a process called gap assessment (this is tool is also used for doing gap assessments for updates to international standards).

During gap assessment, you will compare your existing procedures with every regulation in the MDR. You'll review every regulation and figure out which ones are applicable to your company / products (if certain regulations are not applicable, you will explain why they are not applicable). For the regulations that are applicable, you will identify the procedures that are relevant to that specific regulation. Then you will compare the procedures with what the regulation is asking for and identify any gaps. You will then address the identified gaps by updating your procedures. After you have addressed all the gaps, you can say that your procedures are MDR compliant.

Here's an article you might find helpful.

There are plenty of free MDR gap assessment templates are available online, so my suggestion is to start with that (this way you don't have to copy the regulations in a spreadsheet yourself as this is a massive regulation!).

Hope this helps!
 

Seekingknowledgee

Starting to get Involved
#5
I have read articles and papers and also have seen a few Gap Assessments Templates. Apart from many questions, I have this minor question.

"SOP Gap assessment" is only GAP assessments for SOPs, correct? Or is "SOP Gap assessments" just another way of saying " GAP Assessments" ?
 
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