Are you aware of the transition timeline for the new Medical Device (EU MDR) and In-Vitro Diagnostic Regulation (EU IVDR)?
If you tell me No, then I inform you that you are maybe in trouble. Those new regulations are coming soon into effect so let me tell you, what you should expect.
Objective
The objective of this article is to help you to find your way with all the information you can receive. I will also provide you with some strategies that you can implement in your company.
The most important thing is for you to start now and not put that for later because you don’t have all the pieces of the puzzle.
I am even updating this article every week as I am always discovering new information or new questions.
Partners
If you have a Regulatory Affairs Department or Regulatory Compliance group, please share with them this article (Share it also with your followers on social media). If you are outside or Europe, you should contact your Authorized Representative (Here is an article about it).
These groups should help your company to define the strategy.
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Video: MDR Transition Training
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EU decided to postpone EU MDR for 1 year
Due to the Coronavirus pandemic that started in December 2019 in China and spread all over the world, the EU Commission made a proposal to postpone the implementation of the EU MDR 2017/745 that was planned on May 26th, 2020 to May 26th, 2021.
In this podcast episode with Erik Vollebregt from Axon Lawyers, you will hear what are the consequences of it.
Table of content
- History about MDR and IVDR
- When are the new Regulations applicable?
- What is the truth with the transition timeline?
- Advanced information on the transition timeline
- FAQ on the transition timeline
- Want to transition until May 2025?
- Definition of "Placing on the market"? (Video)
- Transition difficulties
- EU MDR Survey (What a shock!)
- Podcast Episode
- Summary
History about MDR and IVDR
The MDR 2017/745 and IVDR 2017/746 were published in May 2017. And before that, there were 3 different directives.
See below
This reduction will provide more clarity for some companies. And also clarity between both new regulations as the chapters are nearly similar.
Many actions should be equally performed by the manufacturers following MDR and those following IVDR.
When are the new Regulations applicable?
For the Medical Device Regulation (MDR 2017/745) the transition period is 3 years. This is ending by May 26th, 2020. But with the postponement voted, this will be now implemented on May 26th, 2021
And for the In-Vitro Diagnostic Regulation (IVDR 2017/746) the transition period is 5 years. So this means that this should be implemented by May 26th, 2022.
What is the truth with the transition timeline?
But something that we didn’t tell you is the fact that in reality, this transition timeline was initially for the Notified Bodies.
Surprise!!!!
On November 2017, Team-NB mentioned that around 26 Notified bodies for MDR and 7 for IVDR applied to be certified.
Not all of them were able to provide that on-time.
On October 9th, 2018, the European Commission published a status of the situation called “State of play of joint assessments of Notified Bodies in the Medical Device Sector”.
This PPT will provide you some KPI on the different audit performed and planned for MDR and IVDR.
In July 2019, we should have the names of the confirmed Notified Bodies and to be honest with you I hope for you that your Notified Body is on the list. If it’s not on the list you are in trouble. Going from around 80 to 20 or less Notified Body will be a drama for many companies, but I am sure a lot still don’t know that.
NANDO for Notified Bodies
For example, when I go to the NANDO website where are listed the Notified Bodies, I click on Withdrawn, choose the regulation applicable and I see all Notified Bodies that lost their accreditation for this regulation. Look if yours is already there just to be on the safe side.
As soon as you have the names of the approved Notified Bodies you need to rush to get a date for your MDR certification, but this depends also on when your current certificate is expiring. This is the trick.
Why do I say that?
Hard and Soft Transition Timeline
What many Manufacturers don’t know is the fact that there is a Hard transition timeline and a Soft one.
- The Hard transition timeline starts as of May 26th, 2021. It means that manufacturers should be ready by Day 0.
- And there is a Soft transition timeline (4 years), which can go until May 26th, 2024.
But are you part of the Hard or Soft transition? Let me show you who is eligible for which.
What is important to understand is the fact that there is still a lot of unknown information that will be delivered a piece per piece by the European Commission.
- EUDAMED database which will be launched in May 2022 (Delayed from the first plan that was May 2020),
- UDI accredited companies to provide you the UDI-DI,
- publication of Common Specification, Harmonized Standards or Guidance.
So this is why the manufacturers should implement MDR with what they know now. But things can change on the way.
Advanced information on the transition timeline
This part of the article is really important as I’ll provide you also some strategies or options you can follow. But the best partner for this to help you build your strategy, will be your Regulatory affairs department.
Hard Transition
Day 0 (Hard transition) is for the products that have no CE certificate at the date of the transition period. The products that are on this scope are:
- Class I products: Because they are self-certified so no need of a Notified Body
- New Products on scope as the ones from Annex XVI: Those products have no CE mark for now. They were not on scope of MDD 93/42/EC. For those companies, it will be really difficult as I suppose it’s the first time that they’ll have to experiment with a Medical Device Regulation in general. Leave us a comment if you have some questions me or the community will try to answer to it.
- Custom-made Implantable Class III products: New category
- The last case where you’ll have to immediately get certified by May 2020 is if your existing certificate expires on May 26th, 2020
If you are a bit struggling about the Medical Device Classification, then you need to read my article which contains also a video on the topic. You’ll learn everything on the classification of a product and receive also a free form to use to help you.
Now, if you are in that transition situation, I really ask you to act now. Don’t wait and really put in place all the efforts if you want your business to survive.
Soft Transition
On the other side, you have also those companies that can keep the MDD certificate for a maximum of 4 years. It is for the products with a CE Certificate valid as of May 2024.
Let’s take an example: If your certificate expires on July 18th, 2022 for example, you can still sell your products with CE Mark under MDD 93/42/EC until this date. So a piece of advice, if you have the possibility to renew your certificate before May 2021 don’t hesitate to contact your Notified Body now. This will then give you the opportunity to go until May 2024 which will be then your real transition timeline.
But be careful of one thing. Even if your products are still under the MDD certificates, the manufacturer is obliged to follow some MDR requirements as:
- PMS, PMCF
- Registration requirements (Economic Operators…)
- UDI requirements
And the cherry over the cake is that you’ll have at the same time to follow the MDD pre-market requirements.
Another thing that is important. With the Corrigendum 2 of the EU MDR 2017/745, there was a change. Now all products that where class I under EU MDD 93/42/EC and which will need a Notified Body with the MDR benefit from a 3 year transition period. This means that they will need to apply EU MDR 2017/745 by May 26th, 2024.
The Date of application of the EU MDR 2017/745 should be changed to May 26th, 2021
FAQ on the transition timeline
I have also something for you. It’s an FAQ issued by the CAMD (Competent Authorities for Medical Devices) on the transition to MDR.
This list of questions and answers is really important for your to read.
The only problem you’ll have will be about interpretation. So if there is something that you struggle with, don’t hesitate to drop a comment. I’ll do my best to find the answer.
And I know that IVDR people also have a lot of questions so they also have an FAQ issued.
Want to transition until May 2025?
If after all this you still want to extend the transition of your products sell off until May 2025 (5 years after the start of MDR), you just have to do one thing.
You should place your products on the market (With appropriate QMS approvals and a valid declaration of conformity) before the expiration of your certificate or before the start of the transition period (MDR article 120 paragraph 3 and 4).
See the next section for the definition of “placed on the market”.
But after May 2025, those products compliant under MDD cannot be sold anymore. You then need to plan accordingly.
Definition of "Placing on the Market"?
I decided to create a video to explain to you what means “placing on the market” as a summary.
And I added some references below with more definition and explanation as this topic can be misleading.
I hope you’ll like the video. Don’t forget to give me a thumbs up in that case. It would mean the world for me.
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More information
This is really a difficult question. The interpretation of this sentence can change all the strategy of a company.
My first assumption was that as soon as the product is released (documents signed and approved), it means that the product conforms to the regulation.
But after some research, I find the exact definition of what means and what doesn’t mean “placing on the market”.
Blue Guide Definition
This definition is available on the Blue Guide. If you look at paragraph 2.3, says:
the manufacturer and the importer are the only economic operators who place products on the market (49). When a manufacturer or an importer supplies a product to a distributor (50) or an end-user for the first time, the operation is always labeled in legal terms as ‘placing on the market’.
So if a manufacturer wants its products to be placed on the market he should have them under the control of another entity.
One interesting part of this definition is this one:
Placing a product on the market requires an offer or an agreement (written or verbal) between two or more legal or natural persons for the transfer of ownership, possession or any other property right concerning the product in question after the stage of manufacture has taken place (51). This transfer could be for payment or free of charge. It does not require the physical handover of the product.
It means that you can still have the products on your stock but officially these belong to a distributor or end customer.
Building stock inside the manufacturing plant
The reason of this precision is that some manufacturers can have the idea to build stock inside their own plant and say that they are placed on the market (It was something I thought possible too).
But another part of the definition says:
Placing on the market is considered not to take place where a product is:
[…]
— in the stocks of the manufacturer (or the authorized representative established in the Union) or the importer, where the product is not yet made available, that is, when it is not being supplied for distribution, consumption or use, unless otherwise provided for in the applicable Union harmonization legislation.
So be careful to have a good interpretation of these definitions so you can implement the best strategy for your company. Let’s see options.
Strategy
So if you still want to sell your class I products after May 26th, 2020 or your Class Im, Is, IIa, IIb, III products after their MDD certificate expires, then you’ll need to give the possession of your products to a distributor or to the end-user.
Those products will be considered as “placed on the market”.
As mentioned, this can be done on paper but not physically. So products can still be in your storage area but in reality, they belong to another entity.
For a company that owns a manufacturing plant and a distributor, this can be easy to make this arrangement.
But for companies that have only a manufacturing plant under their control, this can be a problem if their distributor doesn’t want to buy the stock.
All this is purely a company strategy. But the clock is ticking so this should be defined as quick as possible.
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Transition difficulties
At this moment, the Medical Device Industry is really stressed everywhere.
Many transitions are in progress and all those changes at the same time make the journey difficult for the executives who have to decide where to invest.
- The new ISO 13485:2016 has his due date on March 2019.
- MDSAP start to be a requirement. Some countries make it mandatory as Canada. (Check below for a video explaining what is MDSAP)
- MDR changes in May 2021
- And in Europe Brexit is also a problem if some companies make business with the UK or are from there. (What about certificates from UK Notified Bodies?)
But all this needs money, and I am sure there will be some hard decision made like to give up on some products or on the business.
If I summaries, there will be less
- Notified Bodies,
- Manufacturers.
- Economic Operators as less external manufacturers will try to enter the EU market.
So the Healthcare market will be safer for patients with only big players that have enough money to keep the business going.
But as competition will drop the prices of the products will get higher.
I’ll let you imagine the future. So take action NOW.
Brexit is now planned for January 1st, 2021. And the EU MDR date of application is postponed for 1 year.
Video: What is MDSAP?
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EU MDR Survey (What a shock!)
A recent survey from KPMG and RAPS shows that:
“78% of Medical Device companies stated that, as of today, they do not have a sufficient understanding of the EU MDR legislation”
This is a really shocking sentence.
Because if you think about it, imagine now that 100 manufacturers are in your country. If I translate this sentence, only 22 will remain on business by May 26th, 2021.
What are you saying to me?
Let’s be honest, if they are not aware now of what is EU MDR then they also don’t know that a real tsunami is coming to them. I know some will say that I am exaggerating, And really I hope you are right because if you are not, those manufacturers are dead.
- Unless Europe is not their primary market which is then something that can save them.
- Unless they have a big budget to start their strategy but finding consultants, resources will be their major issue. All other companies already hired them.
By the way, for those interested to learn the fundamentals of the new EU MDR 2017/745, I created a free Mini-Course on this topic that will be beneficial for you. As soon as you’ll be aware, then you’ll act.
See section below
Do you want to know how to get EU MDR certified?
Podcast Episode 2 - The new Medical Device Regulation
If you are interested in a podcast to listen, I created the Medical Device made Easy Podcast. Below is the episode about the new Medical Device Regulation.
Don´t hesitate to listen to it and subscribe to the podcast on any of your preferred platforms here.
Youtube
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How to build an MDR or IVDR project?
When you are starting a project to be MDR or IVDR compliant, this always start with the same process.
I will try to define the high-level pathway and then I will show you some of the videos I have made where I am presenting them.
Different Steps
- Diganostic
- Quality Management System Update
- Product documentation update
- Economic operator documentation update
- Employee training
Now if you want to hear more regarding these different steps, I encourage you to check the LinkedIn Live that I recorded with Stefan Bolleininger from be-on-quality.
But this is not the end. When you run these kinds of projects there are some pitfalls that can happen.
I have interviewed Angelina Hakim from Qunique who shared with us the list of pitfalls that she experienced. Check that in the article below.
Need help
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Summary
Let’s summarize what you should do:
1- Contact your Notified Body to know if they applied for the new MDR 2017/745 or IVDR 2017/746.
2- Check your certificate to see what is the expiration date.
- If it is before May 2021 for (MDR 2017/745), try to get your MDD certificate renewed so you can have a longer transition period.
- If it’s after May 2021, then the date between May 2021 and your Certificate expiration date is your real transition period.
3- If your products are Class I, you should be ready by May 26th, 2021. or place on the market your products before that date so you can still sell them until May 26th, 2025.
4- If your products are class I under MDD but up classified by MDR, then you have an extension of the transition period until May 26, 2024. But only if your product was placed on the market prior to the date of application.
5- If your product is part of Annex XVI (New Products without Medical Purpose), you should be ready by May 26th, 2021 but need to wait until the Common Specification for your product is released. Then you have 6 months to be compliant.
6- If your products are custom-made Implantable Class III, you should be ready by May 26th, 2021.
But you need to remember that there are many options and only you can decide.
I hope you understood the message as I repeated many times the same sentence with the same date May 26th, 2021 (People should see something like 7 times to remember it).
If not, post a comment to this article so I can answer your questions.
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.
