EU National Registrations

Services for Device Registration in France

in EU National Registrations

Background

Under the Decree n° 2002-1221 September 30, 2002 and Decree n°2010-270 March 15, 2010, four categories of medical devices require to be registered with the French Agency for the Sanitary Security of Health Product (AFSSAPS) at the time of being put into service within French territory (click here for official letter by AFSSAPS).

Categories of medical devices concerned by this obligatory communication are:

  • Class IIa medical devices
  • Class IIb medical devices
  • Class III medical devices
  • Active implantable medical devices (AIMDD)

Registration Process

The registration process consists of following 5 steps:

  1. Designation of an E.A.R.!
  2. Provide E.A.R. with relevant documentation (to be provided upon request)
  3. E.A.R reviews your documentation 
  4. E.AR communicates the information to AFSSAPS 
  5. E.A.R provides you with an acknowledgement of delivery

Addition Information:

Medical devices having same intended use (same commercial name, the same EC declaration of conformity and the instruction for use) are subject to only one communication. The communication must be made at the time of the putting the medical device into service (article 1 of the MDD 93/42/EEC) onto the French territory.

Please bear in mind, that if the communication is not submitted at the time the device is put into service, article R.5461-1of the code of public health lays down penalties incurred by the contravener.

Third party commercial entities, like distributors, should not register devices for several reasons, a few of which are:

  1. By allowing a third party commercial entity to register in your behalf, the manufacturer relinquishes an essential part of his control over his product in the European Market (such as in France);
  2. If decided to end the relationship with a commercial distributor at any point, it will be required to take the device completely off the market until a re-registration is completed for a second (third, fourth, etc.) time;
  3. Third party commercial entity will expect exclusivity, limiting the open distribution of devices.

Conclusion:

  1. For the benefit of non-EU manufacturer, the distributor SHOULD NOT have part in any regulatory affairs;
  2. The manufacturer should register their products with the French Authorities through his appointed Authorized Representative.

Local Legislations, such as this one, are growing rapidly in Europe (Italy, Portugal, France and Germany) and strengthen the need for a professional European Authorized Representative present at all times.


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Services for Device Registration in Italy

in EU National Registrations

Placing your medical device into the European market is contingent upon your compliance with the Medical Device Directive (93/42/EEC). While this Directive is a law to all 27 member states within the European Union, each member state has its own way of implementing the Directive within their country, essentially adding regulations to the Directive and creating Local Legislation.

An example of such local implementation of the Directive is now present in Italy which requires, in addition to the CE marking (as opposed to the essence of the CE marking which is “Free Circulation of Goods”), that ALL Medical Devices to be placed in the Italian market will go through a Device registration process. This process is similar to the pre-market notification requirement for Class I Medical Devices (as stated in the European Directive MDD 93/42/EEC Article 14) only in Italy it is applicable for all classes, not only Class I.

As a non-EU manufacturer of medical devices, you are required to use a European (legal) representative to register your medical device with the Italian database. Non-Italian (European) manufacturers are also required to complete this registration themselves or appoint a legally-mandated representative to register for them.

This representative will communicate with the Italian Ministry of Health on your behalf. The registration can only be done with granted access to the Italian Database, and with the required “smart card” for the actual registration. Your legal representative needs to have access to both.

Third party commercial entities, like distributors, should not register your medical devices for several reasons, a few of which are:

  1. By allowing a third party commercial entity to register in your behalf, the manufacturer relinquishes an essential part of his control over his medical device in Italy
  2. If you decided to end the relationship with your commercial distributor at any point, you would be required to take your medical device completely off the market until you could re-register that medical device within Italy for a second (third, fourth, etc.) time
  3. Your third party commercial entity will expect exclusivity, limiting the open distribution of your medical device.

Conclusion:

  1. For the benefit of non-EU manufacturer, the distributor SHOULD NOT have part in any regulatory affairs
  2. The manufacturer should register their medical devices with the Italian database through his appointed Authorized Representative

Local Legislations like the example of Italy are growing rapidly in Europe (such as in Portugal) and strengthen the need for a professional European Authorized Representative present at all times.

HOW TO GET YOUR DEVICES REGISTERED IN ITALY?


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Services for Device Registration in Latvia

in EU National Registrations

Background

Under the Latvian Regulation No. 581 adopted on 2 August 2005 by Cabinet of Ministers, three categories of medical devices require to be registered with the State Agency of Medicines of Latvia (ZVA) at the time of being put into service within Latvian territory. (Please see Article 1 General Provision, paragraph 20 of the Regulation No. 581)

Categories of medical devices concerned by this obligatory communication are:

  • Class IIb medical devices
  • Class III medical devices
  • Active implantable medical devices (AIMDD)

Registration Process

The registration process consists of following 5 steps:

  1. Designation of an E.A.R.!
  2. Provide E.A.R. with relevant documentation (to be provided upon request)
  3. E.A.R reviews your documentation 
  4. E.AR communicates the information to ZVA
  5. Information available in LATMED

Additional Information:

Medical devices having same intended use (same commercial name, the same EC declaration of conformity and the instruction for use) are subject to only one communication. The communication must be made at the time of the putting the medical device into service (article 1 of the MDD 93/42/EEC) onto the Latvian territory.

Please bear in mind, that if the communication is not submitted at the time the device is put into service, the manufacturer is subject to penalties.

Third party commercial entities, like distributors, should not register devices for several reasons, a few of which are:

  1. By allowing a third party commercial entity to register in your behalf, the manufacturer relinquishes an essential part of his control over his product in the European Market (such as in Latvia);
  2. If decided to end the relationship with a commercial distributor at any point, it will be required to take the device completely off the market until a re-registration is completed for a second (third, fourth, etc.) time;
  3. Third party commercial entity will expect exclusivity, limiting the open distribution of devices.

Conclusion:

  1. For the benefit of non-EU manufacturer, the distributor SHOULD NOT have part in any regulatory affairs;
  2. The manufacturer should register their products with the Latvian Authorities through his appointed Authorized Representative.

Local Legislations, such as this one, are growing rapidly in Europe (Italy, Portugal, France, Germany and Latvia) and strengthen the need for a professional European Authorized Representative present at all times.


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Services for Device Registration in Greece

in EU National Registrations

Background

In accordance with Greek transposition of MDD 93/42/EEC, as published in the Greek Government Gazette, number 2198, dated 2 October 2009; article 14, paragraph 1, all medical devices must be registered with the Greek Ministry of health (EOF) before being placed on the market in Greece.

Categories included in the requirement are:

  • Class I, Is, Im
  • Class IIa, IIb, III
  • Custom Made Devices
  • Kits

Registration Process

  1. Establish a European Authorized Representative (E.A.R.)
  2. Provide all required documents to E.A.R.
  3. E.A.R. proofs all documents and prepares them for submission
  4. E.A.R. submits required documentation to EOF
  5. E.A.R. provides proof of submission
  6. Products may circulate in the Greek market, provided acceptance by authorities

Additional Information

In order to maintain relationships free from mixed association (commercial vs. regulatory needs), the E.A.R. should be separate from the distributor for the following reasons:

  1. By allowing a third party commercial entity to register in your behalf, the manufacturer relinquishes an essential part of his control over his product in the European Market (such as in Greece).
  2. Device registration is connected to the representative registering the product, therefore if it is decided to end the relationship with a commercial distributor at any point, it will be required to take the device completely off the market until a re-registration is completed for a second (third, fourth, etc.) time.
  3. A Third party commercial entity will expect exclusivity, limiting the open distribution of devices.

Conclusion

For the long-term benefit of the non-EU manufacturer, the Greek Registration should be done by the European authorized representative appointed to represent products in the European Union, being free from all commercial interests.

Additional national registrations and additional requirements are becoming increasingly popular as European directives are transposed into national legislation (France, Portugal, Italy & Latvia), thus increasing the necessity for a single European Authorized Representative.


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Services for Device Registration in Portugal

in EU National Registrations

Background:

According to Article 11 of Decree-Law No. 145/2009 published on 17 June, 2009 and transposed into Portuguese law Directive No. 2007/47/CE of European Parliament and Council, ALL CLASSES of Medical Devices (Class I exempt) must be registered online with the national regulatory authority, INFARMED. If the Manufacturer is headquartered outside the European Union, the requirements under the Portuguese regulation must be completed by a legal representative in the Community or, European Authorized Representative (E.A.R.)

Registration Process:

  1. Designation of an E.A.R.!
  2. Provide E.A.R. with relevant documentation (to be provided upon request)
  3. Documentation review 
  4. Registration with INFARMED

Addition Information:

Group Management (a new function in the database) allows select medical devices to be grouped independent of the date the medical devices were registered. Groups are never “closed” which allows for the addition or elimination of devices.

Different presentations of medical devices, for example different quantities or sizes, are considered only one medical device as there is no difference in their compounds or end usage.

It is ill-advised for third party commercial entities (Distributors) to register a manufacturer’s products for a number of reasons:

  • The manufacturer relinquishes an essential part of his control over his product in Portugal by registering his devices through his distributor.
  • If a manufacturer ever decides to end their relationship with their commercial distributor, he would be required to remove the product completely from the market until it is re-registered.
  • A third party commercial entity will expect exclusivity, limiting the open distribution of the product.

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