Medical Device Registration & Technical Format/Template - European Union

S

sree.sree

Starting to get Involved
#1
#1
Dear all,

we are new firm/dummies for Device marketing in Europe.We want market surgical gowns,Drapes.

Please share the information reg'..EU

1) How to register&Fee structure.?
2)Any sample submission/template .?

really im thankful to you.
Humble request.
 
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P

pkost

Trusted Information Resource
#2
#2
Re: device registration&Technical format/template

I'm making the following assumptions:
  • when you say you want to market, you are saying you are going to manufacture.
  • you are not based in Europe
  • your surgical gowns and drapes are sterile

  1. Read directive 93/42/eec - http://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:31993L0042
  2. Create a technical file, with the required information, including (but not limited to) demonstrating compliance with the essential requirements of Annex I of the above directive
  3. Appoint a notified body (Based in EU) (http://ec.europa.eu/growth/tools-da...m?fuseaction=directive.notifiedbody&dir_id=13) (because your device is sterile)
  4. find an EC-rep and enter into an agreement with them (required because you are outside of the EU)

This is a very simplistic overview; I would actually recommend finding a good EC-rep to start with as they will be able to guide you through the regulatory process as well as acting as an EC-rep.

It is important to note that notified bodies cannot act as consultants so will not be able to guide you
 
Ronen E

Ronen E

Problem Solver
Staff member
Moderator
#3
#3
Re: device registration&Technical format/template

While I agree with most of the above, I differ on two points:

1. You can hire the services of a NB based outside the EU, eg an overseas branch in your home country or a nearby one. It's true that almost all NBs are headquartered in the EU (the one that I know that isn't is the Australian TGA), however some have branches in other countries. I guess that this is what pkost meant to say (or I just misunderstood)...

2. I wouldn't necessarily recommend to rely on an EC-rep as a source of regulatory advice. Not all of them are properly geared for that, and even if they are an adequate level of expertise is not guaranteed because they are not obliged by EU law to have/offer such expertise (this will change in a few years but at the moment / under 93/42/EEC this is the situation). You might find a highly qualified EC-rep but don't take it for granted - verify it. Alternatively either immerse yourself in the regulations and abundance of guidance documents (look first for ones called "MEDDEV"), or hire an experienced regulatory affairs consultant to guide you through - you can probably easily find one in your home country (speaking your own language, too).

Cheers,
Ronen.
 
S

sree.sree

Starting to get Involved
#4
#4
Re: device registration&Technical format/template

pkost said:
I'm making the following assumptions:
  • when you say you want to market, you are saying you are going to manufacture.
  • you are not based in Europe
  • your surgical gowns and drapes are sterile


[*]Create a technical file, with the required information, including (but not limited to) demonstrating compliance with the essential requirements of Annex I of the above directive
[*]Appoint a notified body (Based in EU) an EC-rep and enter into an agreement with them (required because you are outside of the EU)
[/list]

This is a very simplistic overview; I would actually recommend finding a good EC-rep to start with as they will be able to guide you through the regulatory process as well as acting as an EC-rep.

It is important to note that notified bodies cannot act as consultants so will not be able to guide you
Click to expand...
Dear sir,many thanks for your response.We are having both Sterile and non sterile.By the way i had read out above guide lines.At present need to guide to registration process&Fee(link plz)also sample submission/template for quick under stand.please share ....
 
S

sree.sree

Starting to get Involved
#5
#5
Re: device registration&Technical format/template

Ronen E said:
While I agree with most of the above, I differ on two points:.....
Click to expand...
Dear sir,thanks for your response. kindly share any example submissions/formats(class-1&2) and Registration method.We are in dummy at present.
 
P

pkost

Trusted Information Resource
#6
#6
Re: device registration&Technical format/template

Costs
Notified bodies charge for their activities, they will charge for technical file review of the sterile product and any onsite audits. The costs vary for every NB

Most competent authorities will charge for you to notify them of the products you want to register with them...Again this depends on each country, you would as a general rule only need to apply in one country for access to all of the EU, however some countries e.g. Italy have additional registration requirements if you want to sell in their country, which incur additional costs

The EC-rep will charge a fee

It is very difficult to give an indication of costs as it is heavily dependent on who you work with

Format
I would generally follow a the STED format as a starting point; registration methods are dependent on country and notified body
 
S

sree.sree

Starting to get Involved
#7
#7
Re: device registration&Technical format/template

k..Im appreciating and thanks to you sparing your valuable time with my thread.

hmm...any link can you provide of any country in EU for registration ???

if any example complete submission temple of any device belongs to 1&2 kindly share me.If any confidential reduction can be done and send PDF/word please.

once again thanks
 
P

pkost

Trusted Information Resource
#8
#8
S

sree.sree

Starting to get Involved
#9
#9
Re: device registration&Technical format/template

once again thanks.

got basic idea.




still expecting from u/others one straight submission which one got approved format.
 
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