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Services for Device Registration in Croatia

Background

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

National registration is required for upper class Medical Devices and IVDs. The registration shall be performed by the person placing the device on the market. However, the EC Rep is allowed to perform the registration as well.

Registration Process

Notifications of placing a medical device on the market are submitted by legal and natural persons who place on the market Class IIa, IIb and III medical devices, in vitro diagnostic medical devices and active implantable medical devices.

Notifications of placing a medical device on the market are sent to the Agency in writing, not later than 15 days from the day of placing the medical device on the market.

The documentation to be submitted with the notification of placing a medical device and in vitro diagnostic medical device is set out in Articles 43 (for medical devices) and 44 (for in vitro diagnostics) of the Ordinance on Essential Requirements, Classification, Registration of Manufacturers in the Register of Medical Device Manufacturers, Registration of Medical Devices in the Register of Medical Devices and Conformity Assessment of Medical Devices (Official Gazette, No. 84/13). Documentation to register an Upper class medical device includes:

– MEDPRO-II / III form filled in, which is set out in Annex 3 to Ordinance No. 84/13;

– manufacturer’s declaration of conformity with essential requirements;

– certificate of conformity of the notified body;

– marking and instructions for use, in accordance with Article 12 of the Act;

– a list of medical products in electronic form.

Documentation to be submitted to register an IVD device includes:

– completed form IVD-MEDPRO, set out in Annex 4 to Ordinance No. 84/13;

– manufacturer’s declaration of conformity with essential requirements;

– a certificate of conformity of the notified body, if applicable;

– marking and instructions for use, in accordance with Article 12 of the In vitro Diagnostic Medical Products Act contained in Annex II to Ordinance No. 84/13 for “in vitro” diagnostic medical products as well as for “in vitro” diagnostic medical products for self-testing;

– a list of “in vitro” diagnostic medical products in electronic form.

According to art. 45 of Ordinance No. 84/13, legal and natural persons that registered an Upper Class medical device or IVD shall be obliged to report any amendment and modification to the information and documentation they have submitted when filing the notice, and in the case of documents issued for a certain period after the expiration of that period, they are obliged to submit valid documents.

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 Croatia;

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 Croatia 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 Croatian database through his appointed Authorized Representative

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

Services for Device Registration in Slovakia

in EU National Registrations

Background

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

Slovak legislation indeed requires the manufacturer of medical devices class IIa, IIb and III, or authorized representative, who under their own name place medical devices on the market and/or puts them into service in Slovakia to notify State Institute for Drug Control (ŠÚKL), that performs the function of the Competent authority for medical devices in Slovakia according to Act No.362/2011 Coll., § 110 sect. 4.

Registration Process

Notification of medical devices in Slovakia only requires a small payment for the creation of the Registration Code.

There are a few requirements for successful and efficient notification:

-correctly 2x filled in Notification form in Slovak language;

-letter of attorney to act on behalf of the manufacturer;

-EC Declaration of Conformity issued by manufacturer (can be in English);

-copy of valid certificate issued according to the conformity assessment procedures (can be in English);

-instructions for use (IFU) in Slovak language both for public and for professionals, SW interface can be in English language, but displayed text must be clarified in Slovak language (e.g.in IFU);

-label of medical device in Slovak language, symbols are acceptable (EN 980, EN ISO 15223-1);

-technical documentation – in the case of borderline product, or in the case of doubts, that the product meets the definition of medical device.

The validity of notification of class IIa, IIb and III medical devices depends on the validity of CE-certificate. Language requirements can be found in MD Regulation No.582/2008 Coll., § 3 sect.2.

Once all the documentation is submitted, ŠÚKL will generate the codes, which are needed for further communication with the Slovak health insurance companies, pharmacies, supply points for medical devices and the Ministry of Health of Slovakia.

Addition Information:

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 Slovakia.

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 Slovakian database through his appointed Authorized Representative

Local Legislations, such as this one, are growing rapidly in Europe (Italy, Portugal, France, Greece, Latvia, Bulgaria and Croatia) and strengthen the need for a professional European Authorized Representative present at any time.

Services for Device Registration in Spain

in EU National Registrations

Background

Under the Spanish Royal Decree No.1591/2009, of the 16^th of October and the No. 1662/2000, of the 29^th of September, four categories of medical devices and three categories of IVDs require to be registered with the Spanish Agency for Medicines and Health Products (AEMPS) at the time of being put into service within French territory.

Categories of medical devices/IVDs concerned by this obligatory communication are:

Class IIa medical devices
Class IIb medical devices
Class III medical devices
Active implantable medical devices (AIMDD)
IVD Self-Testing
IVD Annex II, List A
IVD Annex II, List B

Registration Process

The registration process consists of following 5 steps:

Designation of an E.A.R.!
Provide E.A.R. with relevant documentation (to be provided upon request)
A.R reviews your documentation
AR communicates the information by using the Official AEMPS Web-Portal
A.R provides you with an acknowledgement of delivery and Certificate

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 least 30 days before putting the medical device into service (article 1 of the MDD 93/42/EEC) onto the Spanish territory.

Please bear in mind, that if the communication is not submitted at the time the device is put into service, the Spanish Laws are laying down penalties for the contraveners.

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

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);
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;
Third party commercial entity will expect exclusivity, limiting the open distribution of devices.

Conclusion

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

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:

Designation of an E.A.R.!
Provide E.A.R. with relevant documentation (to be provided upon request)
E.A.R reviews your documentation
E.AR communicates the information to AFSSAPS
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:

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);
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;
Third party commercial entity will expect exclusivity, limiting the open distribution of devices.

Conclusion:

For the benefit of non-EU manufacturer, the distributor SHOULD NOT have part in any regulatory affairs;
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.

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:

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
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
Your third party commercial entity will expect exclusivity, limiting the open distribution of your medical device.

Conclusion:

For the benefit of non-EU manufacturer, the distributor SHOULD NOT have part in any regulatory affairs
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?

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:

Designation of an E.A.R.!
Provide E.A.R. with relevant documentation (to be provided upon request)
E.A.R reviews your documentation
E.AR communicates the information to ZVA
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:

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);
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;
Third party commercial entity will expect exclusivity, limiting the open distribution of devices.

Conclusion:

For the benefit of non-EU manufacturer, the distributor SHOULD NOT have part in any regulatory affairs;
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.

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

Establish a European Authorized Representative (E.A.R.)
Provide all required documents to E.A.R.
E.A.R. proofs all documents and prepares them for submission
E.A.R. submits required documentation to EOF
E.A.R. provides proof of submission
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:

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).
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.
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.

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:

Designation of an E.A.R.!
Provide E.A.R. with relevant documentation (to be provided upon request)
Documentation review
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.