EU MDR Quality Plan template

[Fjohnsonjr]

We are in the process of transitioning to EU MDR
We recently had an Internal Audit by a 3rd Party auditor who was auditing us prior to out annual ISO13485 surveillance audit
One of his findings was that we do not have a Quality Plan in place for our MDR transition.
We have a plan and know we need to document it, so I am looking to see if anyone has a EU MDR Quality Plan transition template that they would be willing to share.
Thanks

 

[Ronen E]

1. If that "finding" was listed as a NC, there must be an unambiguous pointer to an applicable official requirement (e.g. an MDR section, preferably a specific sentence). If it's not a NC, don't fret - it's totally up to you whether you want to invest resources in fixing something that isn't really broken.

2. "a EU MDR Quality Plan transition" is cryptic to me, and sounds like a mash-up of several regulatory/QA concepts. I tend to say, either a Quality Plan or an MDR transition plan. Either way, I think there is no one-size-fits-all template for either. Just write up something that makes sense with your specifics (depending strongly on what it is exactly that you're trying to accomplish).

 

[Ed Panek]

One of my biggest complaints is the ad-hoc method EU used to transition to MDR. Not enough NB, first come first serve, 18-24 month approval timlines as best case.

The bottom up hands off approach EU is using and asking "Manufactures to define plans" when they have almost no control over most of the process is crazy. I can make a plan but any timelines are right out the window. We control almost nothing in the process.

 

[Ronen E]

Ed, I agree that it's a tough situation for manufacturers, but they are far from helpless victims in this case.

There were 4 years to prepare for MDR between the day it came into force in May 2017 and the (updated) date of application in May 2021, and 30 months (2.5y) to get certified pre-DoA, after the first NB (BSI) was already notified under MDR. There were ample warnings and nudges to be proactive, plan, prepare and act well in advance, but for the most part, managements were complacent/myopic and procrastinated. I think that no one wanted to acknowledge and accept the mammoth in the room (i.e. the unprecedented huge amount of necessary resources and extended timelines, regardless of any bottlenecks - it's simply a huge job). Some manufacturers, however, did the right thing, and are now either already certified or sailing fairly confidently towards that target, with a clear (though maybe lengthy) timeline.

- It's true there's not enough NB capacity. This was highlighted countless times, since even before the MDR came into force in 2017. I give you this, indeed the EU failed miserably on that front. Regardless, some manufacturers read the writing on the wall and made sure to come first and be served first (and in time).

- First come first serve is the common default attitude everywhere and all the time, including the FDA etc. Why is that a surprise / an issue?

- I'm not aware of "the EU asking Manufactures to define plans". It might be a NB thing. It makes sense to formally plan any big project, but where is the official requirement? The OP noted that their "requirement" (he noted it as "a finding" - a little ambiguous) came from a "third party auditor" doing an internal audit (again, little clarity here, but it doesn't sound like it was a NB), so I wouldn't take it as indicating "an EU requirement".

- Manufacturers might have little control over their certification process currently, but they had a lot of control over their actions in the lead up, over the last 5 years!

The cricket danced and played all summer while the ant was hard at work preparing for winter.

 

[Jack Moore]

I realize I am a little late to the party....
However..... There are some areas that refer to "planning" and considering Quality objectives, Planning of Product Realization may be one of those areas.... However, not very well articulated...
7.1 Planning of product realization
The organization shall plan and develop the processes needed for product realization. Planning of
product realization shall be consistent with the requirements of the other processes of the quality
management system.
The organization shall document one or more processes for risk management in product realization.
Records of risk management activities shall be maintained (see 4.2.5).

In planning product realization, the organization shall determine the following, as appropriate:
a) quality objectives and requirements for the product;
b) the need to establish processes and documents (see 4.2.4) and to provide resources specific to the
product, including infrastructure and work environment;
c) required verification, validation, monitoring, measurement, inspection and test, handling, storage,
distribution and traceability activities specific to the product together with the criteria for product
acceptance;
d) records needed to provide evidence that the realization processes and resulting product meet
requirements (see 4.2.5).
The output of this planning shall be documented in a form suitable for the organization’s method of
operations.
NOTE Further information can be found in ISO 14971.

More on planning.... does not say a plan.... This may be where the Notified Bodies are coming from....
5.4 Planning
5.4.1 Quality objectives
Top management shall ensure that quality objectives, including those needed to meet applicable
regulatory requirements and requirements for product, are established at relevant functions and levels
within the organization. The quality objectives shall be measurable and consistent with the quality policy.
5.4.2 Quality management system planning
Top management shall ensure that:
a) the planning of the quality management system is carried out in order to meet the requirements
given in 4.1, as well as the quality objectives;
b) the integrity of the quality management system is maintained when changes to the quality
management system are planned and implemented. All in my humble opinion.....