New MDR 2017/745 Transition Strategy - 2019

#1
Hi,
I need to issue the transition plan from the MDD to the new MDR.
We are manufacturers for class IIa and IIb devices.

Can anyone please help me with a sample of the plan?

Thanks
 
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JoshuaFroud

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#2
Hi Oneves

The transition plan is likely to be highly dependent on your business, your product and gap assessment.

I would suggest the place to start would be to conduct a gap assessment against your current QMS and technical documentation against the new requirements of the MDR. Once you have established what needs be done you can create a transition plan that against your certificate expiry to ensure you are certified to the MDR prior to your MDD certificate expiring.
 

Ronen E

Problem Solver
Staff member
Moderator
#3
There are a lot of free MDR-related resources on BSI's website, including guidance on transition planning.

Please feel welcome to PM me (hover over my R avatar for a few seconds, then click "start private conversation") if you need more help.
 
#4
Our company is IATF 16949 certified. From our last IATF audit, last month we received a corrective action request to get our suppliers from ISO 9001:2015 to IATF 16949. At this time we need to come up with a plan. Our suppliers range from 15 employees to over 300 employees. How do we work with our suppliers to create a plan that works for their company?
 
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