EU IVD Registration - Spain / Italy / France / Germany etc

[fondantcookie]

Hi all.

I am really new to RA and am struggling to get my head around medical device / IVD registration within the EU.

I work for a UK based Medical Device / IVD manufacturer and I have been asked to register a product for sale within the EU.

I have registered this device with the MHRA through their DORS website.

I understand that this now permits the product to be sold across all EU member states plus EAA and Switzerland - (Please confirm?)

However I have also heard that certain countries (ie France, Germany, Italy, Poland, Portugal and Spain) have additional registration requirements...

Please can anyone advise what I need to do on this. I have only been in RA for 3 months and am having very little assistance from my "manager" and am struggling with this request.

I've scoured the internet but the information seems so bitty and not very coherent (or maybe I am misunderstanding).

For info, the IVD I need to register is self-declared (so a low classification - please confirm ?? Haha).

Any help would be greatly appreciated! I sought help previously and I really feel this forum is going to be a valuable asset for me

THANKS

 

[chris1price]

Re: PLEASE HELP ! EU IVD Registration - Spain / Italy / France / Germany etc

Welcome to the world of RA.

Once you have performed all the work needed for your device, then completed and signed your Declaration of Conformity saying you comply with the appropriate directive, you can start selling accross Europe.

However, for UK manufacturers of class 1 devices and IVDs, they need to be registered with MHRA through DORS. Manufacturers in other EU countries need to register with their local department of health (or equivalent).

IVDs that are not on List A or B or are for Self-Testing are self-certification and have no Notified Body review.

In Italy, all devices and IVDs (except self-certification) must be listed on the Minitry of Health Database. This may not be a simple process and may be best handled by an italian distributor (if you have one). It is recommended that self-certification IVDs are on the database, but this is not essential.

For other EU countries, where possible I would talk to local distributors. There is a new registration process in Czech Republic for all devices and IVDs. I believe there may be reductions in taxes in Poland for devices that are registered, although registration may not be essential.

Unfortunately, much on the internet is out of date or just incorrect. (I recently saw a well known consultancy referring to a Class IV medical device on its web site); and I dont know of a good list of specific country requirements within the EU. If anyone does, please share.

Chris

 

[fondantcookie]

Re: PLEASE HELP ! EU IVD Registration - Spain / Italy / France / Germany etc

Thanks for that Chris ! Really really appreciate it

So in essence, the fact I have registered the self declared IVD with the MHRA should be sufficient to allow sale within the EU...?

I have noticed conflicting information on the internet which is why I have been struggling to get this straight in my head.

 

[chris1price]

Re: PLEASE HELP ! EU IVD Registration - Spain / Italy / France / Germany etc

There is a lot of conflicting advise out there, mostly consultants wanting to sell you their services.

For IVDs, the self-certification process feels very light, but as long as you have completed the validation work, design process, put a tech file together and completed the essential requirements; the last step is the Declaration of Conformity. Once that is done, register it on DORS and its suitable for sale.

Just remember that under the the new IVD Regulation, everything will be a very different. Which is why I would strongly advise making sure validation and the Technical File meets the new requirements now.

 

[Josee Roy]

Re: PLEASE HELP ! EU IVD Registration - Spain / Italy / France / Germany etc

There is a lot of conflicting advise out there, mostly consultants wanting to sell you their services.

For IVDs, the self-certification process feels very light, but as long as you have completed the validation work, design process, put a tech file together and completed the essential requirements; the last step is the Declaration of Conformity. Once that is done, register it on DORS and its suitable for sale.

Just remember that under the the new IVD Regulation, everything will be a very different. Which is why I would strongly advise making sure validation and the Technical File meets the new requirements now.

 

[Josee Roy]

Hi,
Some good conversations on this site. Maybe you can help me too!
We have a self-certified IVD product registered in UK with MHRA and a UK Authorized representative. With Brexit coming, our understanding is that we have to register in another country with another Authorized representative and sign a new Declaration of conformity. We have an office in Germany, so we thought we would register there and before March 29. Do we need to register our IVD with some competent entity in Germany? - Is it the DIMDI?

 

[Rincewind]

Hello,

to sell a device in Germany you need to be registered with the DIMDI, correct. A link that might help you could be this one:
Medical Devices Information System
Please note the complete Medical Devices Information System is in german, though.

You do not have to register the device itself but you have to assume a role in the Medical Devices Information System (Importer, Manufacturer, Distributor etc.), that's what your German Dependance should do probably.

From my interactions with the BfArM it feels very much like they themselves have no idea what will exactly happen after March 29 but I could be wrong.

 

[Josee Roy]

Thank you so much! This is super helpful!

 

[Christy.Y]

Re: PLEASE HELP ! EU IVD Registration - Spain / Italy / France / Germany etc

Welcome to the world of RA.

Once you have performed all the work needed for your device, then completed and signed your Declaration of Conformity saying you comply with the appropriate directive, you can start selling accross Europe.

However, for UK manufacturers of class 1 devices and IVDs, they need to be registered with MHRA through DORS. Manufacturers in other EU countries need to register with their local department of health (or equivalent).

IVDs that are not on List A or B or are for Self-Testing are self-certification and have no Notified Body review.

In Italy, all devices and IVDs (except self-certification) must be listed on the Minitry of Health Database. This may not be a simple process and may be best handled by an italian distributor (if you have one). It is recommended that self-certification IVDs are on the database, but this is not essential.

For other EU countries, where possible I would talk to local distributors. There is a new registration process in Czech Republic for all devices and IVDs. I believe there may be reductions in taxes in Poland for devices that are registered, although registration may not be essential.

Unfortunately, much on the internet is out of date or just incorrect. (I recently saw a well known consultancy referring to a Class IV medical device on its web site); and I dont know of a good list of specific country requirements within the EU. If anyone does, please share.

Chris

Hi Chris, you said that In Italy, the devices regsitration can be handled by an italian distributer. How can the distributer conduct the registraion? What information should be submitted? Does any authorized materials by European Representative need? We have a European Representative in Belgium. But he is not willing to help the Italian distributor with the Italian registration. The device we want to register in Italy has been notified to Belgium competent authority.