Need of EU representative if CE marked Med Device not marketed in Europe

[vinay anturkar]

We are Surgial hand drilling (Motorised and battery operated -Bone cutting, Bone Drilling etc.) equipment manufactureres (Class I and IIa)from India. We have got CE marking through notified body. However we do not intend to sell any of our products in Europe NOR have we sold any till date. Our notified body insists that we have to appoint an authorised representative in Europe even if we do not sell in Europe. The cost of maintaining an EU representative is heavy and really a waste for us. It is really unnecessarily too much expense on us. Is there any way out?

 

[J0anne]

Manufacturers outside the EU are not obliged to have an authorised representative.

I have attached part of an official document that explains this.

 

[Ronen E]

We are Surgial hand drilling (Motorised and battery operated -Bone cutting, Bone Drilling etc.) equipment manufactureres (Class I and IIa)from India. We have got CE marking through notified body. However we do not intend to sell any of our products in Europe NOR have we sold any till date. Our notified body insists that we have to appoint an authorised representative in Europe even if we do not sell in Europe. The cost of maintaining an EU representative is heavy and really a waste for us. It is really unnecessarily too much expense on us. Is there any way out?

The MDD's Article 14, section 2, reads:

Where a manufacturer who places a device on the market under his own name does not have a registered place of business in a Member State, he shall designate a single authorised representative in the European Union.

(Emphasis added)

If you don't place your devices on the EU market, the MDD apparently doesn't require you to designate an AR.

Perhaps your NB is concerned over the possibility that you will later commence marketing in the EU, and then your devices which bear the CE marking (but don't show an EC REP) will be in breach of the MDD. Customs might not notice it unless they're vigilant. Perhaps discuss with the NB some safeguards against that risk.

Cheers,
Ronen.

 

[somashekar]

We are Surgial hand drilling (Motorised and battery operated -Bone cutting, Bone Drilling etc.) equipment manufactureres (Class I and IIa)from India. We have got CE marking through notified body. However we do not intend to sell any of our products in Europe NOR have we sold any till date. Our notified body insists that we have to appoint an authorised representative in Europe even if we do not sell in Europe. The cost of maintaining an EU representative is heavy and really a waste for us. It is really unnecessarily too much expense on us. Is there any way out?

Your NB is not keen on where you intend to place your device. As long as you ask him to notify your devices to a CE mark, he understands that you can place your devices in the EU and therefore being out of the EU, the NB will look for your AR in the assessment.
Similar to what our RTO officer will check before he issues a driving license. He is not keen to know if you intend to drive in your backyard or on the busy highway or in the crowded city streets, or in a different city in India, or you intend to drive at all ??? ......

 

[Ronen E]

Your NB is not keen on where you intend to place your device. As long as you ask him to notify your devices to a CE mark, he understands that you can place your devices in the EU and therefore being out of the EU, the NB will look for your AR in the assessment.
Similar to what our RTO officer will check before he issues a driving license. He is not keen to know if you intend to drive in your backyard or on the busy highway or in the crowded city streets, or in a different city in India, or you intend to drive at all ??? ......

I respectfully disagree.

I can see the common sense in the thinking above, however, it's not the NBs job to enforce the entire scheme. Their responsibilities and authorities are clearly defined by the directive. The language of the requirement to designate an AR is very clear, and this requirement doesn't apply if no devices are being placed on the (EC) market. I understand the potential concern and I recommend addressing it with the NB, but strictly speaking I think that they shouldn't be forced to designate an AR.

Enforcement of EC REP designation when devices are actually being placed on the market is in the domain of postmarketing surveillance.

Cheers,
Ronen.

 

[somashekar]

As the device label is a vital part of the review during the MDD assessment, and that the AR information is a part of the device label, I would be very happy to have a NB who will accept a declaration from me about designating a AR in the EU when I place a device on the EU market, and till such time I would not designate., and notify me to CE mark the device.
My label with the CE+NB number and without the EU AR rep information, will then be looked with suspicion elsewhere. Global Market is aware of the CE mark requirements, but not to such micro details. At least the NB would not like to have their number associated with such CE mark.
Vinay, do let me know if you can associate with such a NB. I would be willing to make a change too.

 

[vinay anturkar]

I am glad to have a very lively discussion going on. I Look forward to have some firm conclusion. I will also talk to NB once again.

The directive says
authorised representative? means any natural or legal person established
in the Community who, explicitly designated by the manufacturer,
acts and may be addressed by authorities and bodies in the
Community instead of the manufacturer with regard to the latter's
obligations under this Directive

If I go by the definition, Can I appoint any person (my friend in Europe) as the Authorised representative? (he being a natural person). In that case I can limit my expenses on the fees to AR!

 

[J0anne]

I am glad to have a very lively discussion going on. I Look forward to have some firm conclusion. I will also talk to NB once again.

The directive says
authorised representative? means any natural or legal person established
in the Community who, explicitly designated by the manufacturer,
acts and may be addressed by authorities and bodies in the
Community instead of the manufacturer with regard to the latter's
obligations under this Directive

If I go by the definition, Can I appoint any person (my friend in Europe) as the Authorised representative? (he being a natural person). In that case I can limit my expenses on the fees to AR!

Hello again Vinay. you do not require an Authorised Representative.
If you want to appoint your friend, there are legal responsibilities that must be complied with, however, I don't see the point in you doing this, as you will not be marketing your devices in the EU.

 

[somashekar]

MEDDEV guidance document 2.5/10 HERE
Title: GUIDELINE FOR AUTHORISED REPRESENTATIVES