Legislation on medical devices

Our team has long-standing experience gained through working with manufacturers, wholesalers, retailers, importers and distributors of medical devices. We advise our clients on all aspects of the trade in medical devices. We can complete the whole registration of your product for you and assist you in all phases of the process – from the registration as a wholesaler, through the registration of a medical device, the drafting of specific contracts and the labelling of the device to the advertising and the enforcement of user rights with respect to medical devices. Our cooperation with international specialist consultants in the field of medical devices allows us to ensure that no problem is left unsolved.

Read more:

  • Provision of legal advice on any matters relating to medical devices;
  • Registration of wholesalers, warehouses and medical devices;
  • Drafting of specific technical documentation for medical devices;
  • Examining the options for registration of medical devices;
  • Representation before the Executive Agency on Medicines in all administrative procedures
  • Drafting of specific documents related to medical devices, review of advertising, promotional and other materials intended for the user.
  • Legal representation in court for disputes or sanctions imposed in connection with medical device activities.

Financial Support for Small and Medium-Sized Enterprises (SMEs)

Up to EUR 1,500 to defense the rights in the industrial property sector as a SMEs financial support 


At the end of the last year, the EU Commission, in cooperation with European Union Intellectual Property Office, established a Grant Fund of EUR 20 million supposed to be granted to small and medium-sized enterprises for development and defense of the rights to objects of industrial property.


What is this Aid Like


This financial aid can help with reimbursement of up to EUR 1,500 costs incurred with respect to:

  1. a) pre-diagnostic service of the company’s intellectual property and/or b) fees paid for registration of trademarks and designs.


And here is the rate of reimbursement for each of the two sections:

  • The fund will recover 75% (but not exceeding EUR 1,500) of the costs for the services related to the preliminary diagnostics for the objects of industrial property owned by the company;


The pre-diagnostics of industrial property of the company applicant is carried out and coordinated by the national institutions of the Member States. If you look at the list of the involved institutions, however, you will see that not every Member State is a participant in this program. The good news for the Bulgarian small and medium-sized enterprises is that the Patent Office of the Republic of Bulgaria is a partner of the European Union Intellectual Property Office under this program, which in turn, gives them an opportunity to apply for reimbursement.


Pre-Diagnostics Service is not a legal service. It is performed by experts appointed by the national institution (in this case for Bulgaria it is the Patent Office). Experts, having become familiar with the company’s business model, its provided goods and/or services and future plans, will help the company build up its own strategy and decide which objects of industrial property should be registered.

  • The fund will reimburse 50% (but not exceeding EUR 1,500) of the amount of the fees paid for registration of trademarks and/or designs on a national level (trademarks registered with the Patent Office of the Republic of Bulgaria), on a regional level (trademarks registered within Benelux), or on a European level (trademarks registered with the European Union Intellectual Property Office).

Please note that each country participating in the program, including Bulgaria, is subject to certain admissible amounts of fee for the pre-diagnostic service. There are also admissible amounts anticipated for the registration fees of national, regional, or European trademarks and designs. For example, admissible fees for the registration of trademarks and designs subject to reimbursement, are the basic registration fees excluding the fees for an additional mark class or postponed design publishing. This means that if you pay EUR 1,050 registration fee for the registration of a European trademark in three classes, then 50% of the basic fee will be subject to reimbursement, i.e. EUR 850.

Otherwise, companies are eligible to apply for the reimbursement of costs incurred both for a pre-diagnostic service or paid fees for the registration of trademarks/designs, and for reimbursement of both groups. However, the total amount of the recovered sums will be up to EUR 1,500.

Who Can Apply

The financial support is designed for small and medium-sized enterprises, based within the European Union. The definition says that a small and medium-sized enterprise is an enterprise meeting the following criteria:

Category Staff Turnover (Mil) or Assets (Mil)
medium < 250 ≤ € 50 m ≤ € 43 m
small < 50 ≤ € 10 m ≤ € 10 m
micro < 10 ≤ € 2 m ≤ € 2 m


The application documents for the program, requests for registration of trademarks and/or designs, and the request for reimbursement can be submitted both by the company’s legal representative and by its representative.


When You Can Apply


In 2021 you can apply for the discussed program within five timeframes. For the second half of the year these periods are 01 July – 31 July 2021 and 01 September – 30 September 2021. Please note that any applications submitted outside the referred timeframes will be discarded.


The financial aid rules allow you to submit only one application within a timeframe. Then you can request: a) reimbursement for the costs related to the pre-diagnostic service; b) reimbursement for registration fees; or c) reimbursement for both pre-diagnostics and registration fees. You may not apply for the same service in two timeframes, but you are allowed to apply for reimbursement for one service within one time frame, and for the other service within the next timeframe.


Application Guidelines


First, the enterprise applying for a financial aid under this program should check if it meets the small and medium-sized enterprise criteria. If it does, then it should proceed with the next step to obtain a Bank Account Certificate and a VAT Registration Certificate.


Application forms and any attachments thereto shall be submitted online at the website of the European Union Intellectual Property Office. If it is approved, the company will receive a resolution on the provided grant.




  • A request for a pre-diagnostic service or payments of fees for the registration of trademark and/or design should be submitted within thirty days after receiving of the resolution on the provided grant.
  • The company may apply for reimbursement only after such costs had been spent.
  • No money will be granted under this program for a pre-diagnostic service that has already been done or for applications for registration of trademarks or designs already submitted and paid registration fees.
  • No costs will be reimbursed after expiration of thirty days after receiving of the resolution on providing a grant.


As the statistics shows, small and medium-sized enterprises who have protected their rights to the objects of industrial property used in their business (such as trademarks, inventions, designs, etc.), report almost 70% higher revenues than these companies who have not done that.


In this reference, the opportunity provided by the Patent Office of the Republic of Bulgaria in cooperation with the European Union Intellectual Property Office for the reimbursement for identification and defense of rights to trademarks and designs, will be of a great importance and help for the small and medium-sized enterprises, especially under the conditions of the tough economic environment in the country.


Please pay attention that this article is update as at 20/05/2021 and each case is strictly individual. This article serves for information only and do not accept it as a specific piece of legal advice.

Therefore, before taking any specific steps, and if you cannot find the answers to all questions that you may have, we recommend you get in touch and consult with us, and we will be happy to help you. Enjoy your first consultation for free!

Forthcoming prohibition to put Titanium dioxide (E171) in foods and food supplements

A new law changes on European level are expected regarding the prohibition to put Titanium dioxide (E171) in foods and food supplements that are manufactured, imported or sold in the European union.


The change will affect a lot of manufacturers and retailers of foods and food supplements. The Titanium dioxide is put in the food supplements for years not as an active substance, but as a colorant. The Titanium  dioxide is also used as auxiliary substance for ready to use soups, sauces, nuts etc.


What caused the change?


EFSA/ evaluated E171 quite recently (2016) and declared it safe for putting in foods. However claims were sent to the European association regarding the genetic toxicity of the E171. Great Brittan and the Netherlands are among the member states to raise concerns in 2019 regarding the evaluation of the safe use of E171. Last year /EFSA/ published new evaluation regarding the safe use of the additive E 171 in foods, that you may find here.


/EFSA/ does not have right to change the laws, nevertheless its expertise is leading whenever changes in food laws are passed.


What to expect following the change?


  1. The Titanium dioxide could not be put in manufactured foods and foods supplements following the prohibition. All food consignments that contain E171 planned for manufacturing should be remade and its formulas changed;


  1. During the 6 months transitional period for foods manufactured prior the law is passed it is important to know the following:


  • Foods containing E171 could enter the market up to 6 months from the date the prohibition entered in force and could be sold until the date of expiration of the said foods;
  • Following the 6 months since the law is passed the foods containing E171 that are on the market could be sold until the date of expiration of the said foods.

Example: All food supplements manufactured today containing E171 could be sold on the market until the date of expiration no matter the prohibition.


When will the prohibition pass as a law?


Taking into consideration the complexity of the procedure it is expected the law for prohibition of Titanium dioxide (E171) to pass in the first months of 2022.


Please note that this news is current as of 07.01.2022 and each case is strictly individual. This news is for information purposes only and does not constitute specific legal advice. Therefore, before you take specific action, and if we have not been able to answer all your questions, we recommend that you contact us and we will be happy to assist you. Every first consultation with us is completely free!