Strategy for MDR Regulatory Compliance Procedure

[JP12345]

Hi,

Can anybody share the main areas covered in their Strategy for Regulatory Compliance Procedure as required by MDR? Or point to any guidance on what should be covered by the procedure?

Thanks,

 

[Philip B]

It's difficult to know what the expectation is here, I guess case history will develop as more companies are audited against the MDR. Our procedure covers responsibilities, device classification, essential requirements, conformity assessment route, QMS, changes, hosting audits, compliance with standards, suppliers, economic actors, vigilance, PMS and EU Rep. Not in any detail as most of these have their own procedures, I just threw in anything that had a 'regulatory compliance' element. It seems to me that they are trying to crack down on the rogues who don't have anyone or anything in place to ensure they are compliant, so a procedure that covers who does what will hopefully suffice. Of course, a procedure is just a procedure and needs to be backed up by actual regulatory compliance.

 

[JP12345]

Thank you @Philip B that is really helpful.

 

[William55401]

To me, a single procedure does not make sense. Your task, IMHO, is to take those requirements and translate them into specific responsibilities, tasks, and records in your QMS procedures. A single procedure will not be effective. Map the requirements to where they best fit in your QMS and update only the impacted procedures. This approach would require you to maintain a requirements trace matrix but it is an effective way to manage QMS change. There will be new / revised requirements coming up again and a process to manage change is needed. HTH

 

[James]

To me, a single procedure does not make sense. Your task, IMHO, is to take those requirements and translate them into specific responsibilities, tasks, and records in your QMS procedures. A single procedure will not be effective. Map the requirements to where they best fit in your QMS and update only the impacted procedures. This approach would require you to maintain a requirements trace matrix but it is an effective way to manage QMS change. There will be new / revised requirements coming up again and a process to manage change is needed. HTH

I agree with that perspective. However, I have a 'strategy for regulatory compliance procedure' in my system, and this is to capture the wider regulatory requirements that apply to the system in addition to the MDR. I'm in the UK so the MDR doesn't apply, so the procedure is also an opportunity to clarify what does apply and how; in addition to areas such as H&S legislation that applies to our workshops, etc.