I had the opportunity to participate in a training organized by Angelina Hakim from Qunique and while discussing she talk to me about some issues that happen to some companies while running their MDR or IVDR project.
I immediately thought of asking her if she would accept to share that with other people as this can maybe help to avoid the same issues.
So, here is the interview I have made with Angelina Hakim regarding the Pitfalls of MDR or IVDR projects.
Video: What are some pitfalls to an MDR and IVDR project?
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Side Project
You don’t announce this project as a Main project but it is considered a side project. This can damage the result of this project. If you think that your main objective is to sell products or develop new ones, then you will lose. This type of project needs focus and dedication.
- The company should announce a Sponsor which will really take care of the good progress of the project. He should be able to explain the direction that it should go.
- It’s also clear that this project will cost some money, so not planning some budget to pay for consultants or for tests to be performed can be a catastrophe.
- Resources to help with the project is also key. You cannot give this kind of project to only one person and think that they will succeed. You need a team there with different competences.
If you are not doing that, maybe by May 2020 or by the expiration of your MDD certificate you will not be able to sell more products.
And even if your certificate goes beyond May 2020, don’t think that you have more time. There are still some MDR requirements that you should follow.
Choose the wrong project leader
You should understand that and MDR or IVDR upgrade is not a typical project. It is a complex project with a lot of interfaces.
To drive this project, you need someone that has experience leading projects but also that has a clear understanding of what is MDR or IVDR. He needs to be aware of the Quality and Regulatory requirements for Medical Device products.
In this case this person does not have this background. She will focus on things that are not important and miss the opportunity to solve some major concerns.
In case your project leader is not understanding the Quality and Regulatory requirements, he will need to participate in training. This is key for him and for the company. It will be also important for this person to work closely with the Quality and Regulatory Affairs department of the company.
All this will help to define priorities. The team will really work than on what is important and leave the rest for later.
Starting a Gap Assessment
When MDR and IVDR came in, I heard a lot of companies saying that they need to make a Gap Assessment. But what is a Gap Assessment?
A Gap Assessment is the fact to look at your system or documents and compare it to the requirements described on a regulation. So this will help you to define an action plan to solve this gap.
We had a bonus episode at the Medical Device School where we discuss Gap Assessment with Stefan Bolleininger from be-on-quality.
What is important on a Gap Assessment related to MDR and IVDR project is to start by your Quality Management System (QMS). Because all that you will correct on your QMS will be the foundation for the rest.
Some companies start by updating the technical documentation, but before to do that, you need to define if you have the right templates available. Those templates should be mentioned in your procedure and part of your controlled documents.
So, the templates you will use for your technical documentation will then be approved instead of doing it the other way around. Because non-approved templates can be a major issue when you’ll have to discuss that during an audit.
The gap assessment between a Technical File and QMS can be done in parallel but don’t start to work on technical files and then redo the job for your QMS in a second wave.
In my article related to the “Best QA and RA tools” I have selected a Gap Assessment tool that you can use.
Include all you can inside
This is a tendency that happens on many projects. We take the opportunity of a project to include things that have nothing to do with it.
If we want to make a parallel, imagine that your initial requirement is to change the color of your walls in a certain room because there is some dirt on it. And as you were also thinking to renovate this wood floor then you include it in the quote. And as you change the color of the wall, why not also change the sofa because you think this is not matching.
So a project that was supposed to be 2 months become a 6 months project because you have included many other things that are not really on the initial scope.
Don’t do that with an MDR and IVDR project. This project deserves focus and dedication. Don’t pollute it with other things that are maybe not a priority.
Technical Documentation Templates
- Template compliant to requirements of MDR 2017/745 Annex II and III.
- Formatted with the chapters already defined.
- Guidance provided to help you identify the content to include
- General Safety and Performance Requirements compliant to Annex I.
- Include guidance to prove evidence to the requirements.
Economic operators not involved
Importer, European Authorized Representative, Distributors need to be part of your project.
You will need to update the agreement with those companies and this may be not obvious to them. So you should involve them on-time.
Don’t consider only your manufacturer’s situation but consider all supply-chain so your project is a success.
Even if those economic operators are part of your company, you need to have an agreement.
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Person Responsible for Regulatory Compliance (PRRC)
Don’t forget that Manufacturers or Authorized representatives should appoint a PRRC or Person Responsible for Regulatory Compliance.
I have created an article and a video about the role of a PRRC if you are interested to look at it.
External impacts
You should see that maybe there can be some external impacts on your project.
- Political decisions
For example, Brexit or Swixit completely change your company situation. If some countries are not part of the EU anymore, then they need to choose an EU Authorized Representative and Importer for their business.
- Notified Body
The other thing is to choose the right Notified Body for your company. This choice can determine your success or failure. You need to review if your product is on the scope of its accreditation. You can go to the Nando Database and check that.
You should understand that between MDD and MDR accreditation, some Notified Body may look some products under their scope. But you need to ask them to be sure.
We know that currently beginning of January 2020 there are 9 Notified Bodies for MDR and 3 for IVDR so this is not helping, but you need to investigate the Notified Bodies to see if they understand your business.
Then you’ll need to keep close communication with the Notified Body so they have a clear view of your situation and the timing for your project.
Check this article on helping you to be Audit ready. And the advice is coming from a Notified Body, so really worth it.
Conclusion
If you are running this type of project you need to understand that this is a serious one that can really impact your company. So don’t blame your project leader or the team, if they have no budget, no resource, a leader that is not aware of the requirements….
If you want to place a compliant medical device on the EU market follow the advice provided here.
Medical Device expert. Monir founded Easy Medical Device to help Medical Device companies to place compliant products on the market. He proposes his consulting services so don’t hesitate to contact him at info@easymedicaldevice.com or +41799036836
My objective is to share my knowledge and experience with the community of people working in the Medical Device field.
