CE Marking Services from Obelis

Services for Device Registration in Bulgaria

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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 present in Bulgaria. As a non-EU manufacturer of medical devices, you are required to use a European (legal) representative to register your medical device with the Bulgarian database. Non-Bulgarian 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.

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 Authorized Representative, can perform the registration procedure on behalf of Non-EU manufacturers. A registration application form is provided by BDA and the file is submitted as a hard copy via post or courier.

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.


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 Bulgarian database through his appointed Authorized Representative

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




Obelis Services

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Obelis European Authorized Representative Center provides ISO certified services for the successful introduction of medical devices within the European territory, in accordance to the Medical Device Directive 93/42/EEC and its amendment 2007/47/ECIn-Vitro Diagnostics Directive 98/79/EC and Active Implantable Medical Devices Directive 90/385/EEC.

Those services include, but are not limited to, the following:

Our services are backed by over 25 years of experience with CE Marking consultation and European Authorized Representative services. We are located within walking distance of the European Commission and maintain close relations with the EU Administration.

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European Authorized Representative Services

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Our professional European Authorized Representative services aim to ensure compliance with MDD 93/42/ECCIVDD 98/79/EC and AIMDD 90/385/EEC:

“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 for this device a single authorized representative in the European Union”. -Amendment 42 Article 2, Point 7 - Article 14, paragraph 2, subparagraph 1 

Our services in this area include, but are not limited to:

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MDlaw.eu is an Information Platform on the EU Medical Devices Regulation (MDR), which aims at meeting information needs on the future regulatory framework on medical devices in Europe.

The objective of the MDlaw platform is to help the medical device community prepare for an easy & successful transition to the new MDR requirements.

MDlaw platform aims to provide:

  • European Commission’s Implementing Acts and other Notices
  • Medical Device Coordination Group (MDCG) documents
  • Judgments & Rulings of the European Court of Justice
  • National competent authorities documents
  • Publications by CAMD, NBOG
  • Regulatory updates
  • Position Papers
  • MDR Analysis
  • And more…

Additional Special Features:

  • 108 Questions & Answers on MDR – touching upon the most relevant topics of the Medical Devices Regulation.
  • From MDD to MDR: Transition Management Tool – presenting seven techniques for a smooth transition of economic operators to the new EU regulatory framework.

Find all Medical Device Regulation related documents in 1 place (!) – at MDlaw.eu!


Subscribe NOW and get 3 Months FREE (!)

Visit www.mdlaw.eu to complete your subscription

EU National Registrations

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Services for Device Registration in Bulgaria

Services for Device Registration in Croatia

Services for Device Registration in France

Services for Device Registration in Greece

Services for Device Registration in Italy

Services for Device Registration in Latvia

Services for Device Registration in Portugal

Services for Device Registration in Spain

Services for Device Registration in Slovakia

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Free Sales Certificate Services

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According to the European Medical Device Directive 93/42/EEC and the In-Vitro Diagnostic Directive 98/79/EC, CE marked and properly registered devices in all 27 EU member states and 4 EFTA countries have free access to the EU market (according to Article 14 MDD 93/42/EEC as amended by the 2007/47/EC and Article 10 IVDD 98/79/EC). Thus, once your device is properly CE marked, it is allowed to circulate and be sold throughout the European Union.

However, the CE Marking only enables penetration to the European market and does not enable the device to be placed on other global markets.

Due to the high standards of health and safety required by the CE Marking, customers in non-EU countries request a Free Sales Certificate from the manufacturer to demonstrate the device meets the various safety and health requirements specified by the CE Marking. The Certificate will enable the device to penetrate the market of the relevant country and be freely sold to the public (presuming all local requirements are also met).

As the manufacturer is not within the European territory and cannot communicate with the Authorities, this certificate can only be obtained through the manufacturer’s legal entity in Europe, the Authorized Representative.

In order to get the Free Sales Certificate for MDD and IVD devices, two conditions need to be met:

  1. The device must bear the CE Marking
  2. The manufacturer has appointed a European Authorized Representative for his device


If the device(s) are CE marked, but not properly notified/registered with the European Authorities by the appointed European Authorized Representative (as required by Law for MDD Class I and IVD devices), the CE Marking is NOT valid and therefore the Free Sales Certificate cannot be issued.

To receive a Free Sales Certificate, you will be required to present your Authorized Representative with the following:

  • Information about the device
  • Name and form of the device
  • Classification (according to EU regulation)
  • Composition and description
  • CE Certificate
  • Information about the manufacturer
  • Name and contact details
  • Production Site
  • Contact details for Notified Body

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Clinical Data & Post Marketing Follow Up

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Most medical device companies that currently sell CE-marked medical devices are getting nervous thinking about implementation of EU-MDR compliance and new certification. Especially related to the necessity to present sufficient clinical evidence to support the general safety and performance requirements.  The Medical Devices Regulation applicable as of 26 May 2020 will significantly raise the bar for clinical data.

Among  the new requirements:

  • A clinical evaluation plan and  a clinical evaluation report  is required for all device including class I.
  • The clinical evaluation shall follow a defined and methodological sound procedure and be based on MEDDEV 2.7.1/rev.4 and Annex XIV of the MDR
  • Especially related to the necessity to present sufficient clinical evidence to support the general safety and performance requirements
  • The clinical data should be sufficient to demonstrate compliance with the safety and performance requirements .
  • The clinical evaluation should include a  critical evaluation of the results of all available clinical investigations whether positive or negative
  • The method of appraising the literature need to be documented to assure your critical evaluation, without any bias or underexposure of unfavorable data.
  • Consideration of currently available alternative treatment options for that purpose
  • State of the art against which to measure safety and performance  must be established from Literature Review
  • In order to rely on clinical evidence of  an similar  device already marketed, the biological, technical and clinical equivalence will need to be demonstrated scientifically. Furthermore manufacturer will need to  have sufficient access to design data of the t device with which he claims equivalence.

Results of clinical investigations and/or Post Marketing Clinical Follow Up Studies that you performed in the past or that are currently ongoing, will be very valuable for your clinical evaluation. Similarly results from your post market surveillance process including some form of active collection of data will also represent  an  important input into your clinical evaluation which will be part of your Technical File to be assessed by your Notified Body.

It is therefore urgent for all medical devices manufacturers to critically and objectively analyze the foundation of their Clinical Evaluation Report and assess whether they have clinically sufficient evidence for future MDR compliance? Some devices will surely lack sufficient clinical evidence and might indispensably require some form of active data collection (PMS/PMCF).

As EU Consultant, Obelis can help you understand the new requirements, perform a gap analysis, and assist you to develop a solid plan for clinical data compliance.

Advisory Services

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Obelis aims to provide you with full solutions for the introduction of your medical devices to the European market. Among other things, our team of experts will guide you on:

  • Permitted claims and regulatory advice
  • QMS implementation
  • Product safety consultancy
  • Product testing and certification services
  • Identification of proper regulation
  • Identification of EU harmonized standards
  • Post market surveillance assistance
  • Regulatory advice and updates

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Technical File Services

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Obelis Technical File services include the review and gap analysis of an existing Technical File, as well as the creation of a complete and compliant Technical File.

Our Technical File Review/Creation services include, but are not limited to, the following:

  1. Device Classification.
  2. Identification of applicable standards.
  3. Risk management report and gap analysis.
  4. Clinical evidence report and gap analysis.
  5. Safety and biocompatibility.
  6. Guidance on suppliers/subcontractors agreements.
  7. Templates and checklists.
  8. Labeling & Packaging.

For further information about Technical Files, click here: Technical File Compliance.

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Notified Bodies Selection Services

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Our Notified Body Selection services include:

  • Device Classification.
  • Identification of conformity assessment options.
  • Notified Body offer analysis.
  • Notified Body negotiation.

For further information about Notified Bodies for Medical Devices, click here: Notified Bodies Compliance.

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Additional Services

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Additionally, we also provide the following services:

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Global Services

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At Obelis, our mission is to provide our clients with the finest quality services and personalized solutions to the complex regulatory requirements throughout the world. Therefore, we have developed a wide range of solutions to provide you with support in over 20 markets worldwide. With Obelis, you get:

  • Access to an International Network
  • Regulatory Solutions
  • International representation

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