How long does it take to register a product with MHRA?

[Sieun Baek]

Hello

Our company manufactures Class III HA fillers.

We have MDD CE certificate for our product (HA filler) and are planning to enter the UK market in January 2021.
I know that in order to enter the UK market, product registration for MHRA is required. (This is not mean UKCA marking)
How long does it take to register a product with MHRA?
Also, are there any additional process for sales after registration?
If there are additional process required, how long does it take?

We are expected to ship immediately in January 2021.
In order to sell a product, it is important to check how long it takes for product registration.

I need you guys help. If anyone who know it, please let me know.

Thank you

 

[chris1price]

Have a look at this link from MHRA Register as a manufacturer to sell medical devices

 

[Mikilk]

That is the right link (what you should do after 1st of January2021) Register medical devices to place on the market from 1 January 2021
you should perform the registration through the UK responsible person (all the information is in the link)

 

[Philip B]

The process was fairly quick for us. The registration site takes a bit of getting used to but is fine once you get the hang of it. I wrote a procedure to cover the steps as I figured this would be an infrequent process.

 

[Nisha]

It is fairly a quick process once you appoint UKRP, I would think you can get the registration complete and accepted by MHRA in 7 days

 

[cataltar]

The process was fairly quick for us. The registration site takes a bit of getting used to but is fine once you get the hang of it. I wrote a procedure to cover the steps as I figured this would be an infrequent process.

We are in the process of having our products registered by our UK Responsible person. We have a product family of 380 models with the same indication, however, models in the family have to be assigned different GMDNs due to the presence of different accessories. We already have an EC certificate for a single family and on our DoC, our products are grouped based on their main accessory attached. Our UKRP told us that we must regroup our models based on GMDNs so they could be registered on the MHRA system. This does not seem right.

So, could you advise, is it required to register products based on their GMDN or not? Or is GMDN number provided only for general information and categorization purposes?

If it is required, we will end up registering 6 different product families for our single family. This doesn’t seem intuitive.

to give you an idea we use the following GMDNs for models in the same family and have exactly the same indication.
42743 - Negative-pressure intravenous line needleless valve-connector
42750 - Neutral-pressure intravenous line needleless valve-connector

 

[Philip B]

Sorry, I'm not in a position to comment on your specific situation. I suggest you ask the MHRA, they are normally helpful with queries such as these.

 

[Nisha]

Hello,
The registration on MHRA portal would be based on your EC certificate and GMDN codes assigned as per the DoC.

It should not make a difference how many product families you would register under, unless there is a commercial implication from your UKRP.

 

[Mikilk]

In the UK you should open a device per GMDN code (so it's not 100% in correlation with the CE certificate that can be according to families)
let me try and explain
the system requires to open a "Device" which is related to the GMDN code (we cannot just create a general family, it should be linked to a specific GMDN code) so if there are different GMDNs - we cannot combine them under one device registration or a family.


under the device that was created, we can create additional products (different products that have the same GMDN code and same Class) we cannot add 2 classes under the same device if a GMDN code somehow has 2 classes, we will need to create 2 separate devices.


even if we use the option of loading excel with bulk products - we will need to use a separate excel file template for each device (GMDN code)

 

[marie.doe]

@Mikilk

How to register 3 different models of the same type of medical device with the same GMDN code but with 3 different technical files?