National Registration for medical devices

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 present in Bulgaria. All non-EU manufacturers of medical devices and IVDs are required to have an EU legal representative to register their device with the Bulgarian Drug Agency (BDA). Non-Bulgarian manufacturers that are based in the EU are also required to complete this registration themselves, or appoint a legally-mandated representative to perform a registration for them.

Registration Process

In accordance with the Law on Medical Devices, adopted by the Bulgarian Parliament during its session on June 12, 2007, and as promulgated in the Bulgarian State Gazette No. 46, some categories of medical devices must be registered with the Bulgarian Drug Agency (BDA). This registration is mandatory for medical devices that enter the EU internal market through, or if they are being manufactured in, the territory of Bulgaria. The categories of medical devices that are affected by this obligatory registration are:

• Class I Medical Devices;
• Class Is and Class Im Medical Devices;
• Custom-made Medical Devices;
• Systems and procedure packs;
• Systems and procedure packs subjected to sterilization before use;
• Medical Devices subjected to sterilization before use;
• In-Vitro Diagnostic Devices

The manufacturers of Medical Devices that are classes IIa IIb and III, and established outside Bulgaria, are exempted from this requirement. Obelis, as a professional European Authorised Representative, can perform the registration procedure on behalf of Non-EU manufacturers. 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 Bulgaria;
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 Bulgaria for a second (third, fourth, etc.) time;
3. Your third party commercial entity will expect exclusivity, limiting the open distribution of your medical device.

Placing your medical device on 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 Croatia. All non-EU manufacturers of medical devices and IVDs are required to have an EU legal representative to register their device with the Agency for medicinal products and medical devices of Croatia, HALMED. Non-Croatian manufacturers that are based in the EU are also required to complete this registration themselves or appoint a legally-mandated representative to perform a registration 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, no 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.

Some categories of medical devices are mandatory to be registered with the French Agency for the Sanitary Security of Health Product (AFSSAPS), at the time of being put into service within the French territory as per the Decree n° 2002-1221 September 30, 2002 and Decree n°2010-270 March 15, 2010. Categories of medical devices concerned by this obligatory communication are:

• Class IIa medical devices
• Class IIb medical devices
• Class III medical devices

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

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 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.

All medical devices, including IVDs that are to be placed on the Greek market, must be registered with the Greek Ministry of health (EOF) in accordance with Greek transposition of MDD 93/42/EEC, as published in the Greek Government Gazette, number 2198, dated 2 October 2009.

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 the 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.

Upper class medical devices and IVDs must be registered with the State Agency of Medicines of Latvia (ZVA) and have their information must be available in LATMED based on the Latvian Regulation No. 581 adopted on 2 August 2005. 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.

Upper class medical devices and certain IVDs must be registered online with the national regulatory authority, INFARMED – as per Decree-Law No. 145/2009 published on 17 June, 2009. For non-EU manufacturers, the requirements under the Portuguese regulation must be completed by the EU legal representative/ European Authorized Representative (E.A.R.)

Registration Process

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

Additional 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.

Placing medical devices and IVDs on the Spanish market require an additional registration to be performed with the Spanish Agency for Medicines and Health Products (AEMPS) as per the Spanish Royal Decree No.1591/2009, of the 16th of October and the No.1662/2000, of the 29th 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 Spanish territory. Categories of medical devices/IVDs concerned by this obligatory communication are:

• Class IIa medical devices
• Class IIb medical devices
• Class III medical devices
• IVD Self-Testing
• IVD Annex II, List A
• IVD Annex II, List B

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. A.R reviews your documentation
4. AR communicates the information by using the Official AEMPS Web-Portal
5. A.R provides you with an acknowledgement of delivery and Certificate

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 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:

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.

All non-EU manufacturers of medical devices and IVDs are required to have an EU legal representative to register their upper class medical device with Slovak State Institute for Drug Control (ŠÚKL) – based on the  Act No.362/2011 Coll., § 110 sect. 4. Non-Slovakian manufacturers that are based in the EU are also required to complete this registration themselves or appoint a legally-mandated representative to perform a registration for them.

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.

Additional 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.
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 Slovakia for a second (third, fourth, etc.) time.
3. Your third party commercial entity will expect exclusivity, limiting the open distribution of your medical device.