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The New Regulations on Medical Devices – the Challenges for Companies


    • Comprehensive legal services encompassing all the business activities of a client, such as:

      • Negotiations and deal mediation;
      • Preparation and drafting of civil, trade, labour, and other agreements, memoranda and other documents related to a client’s business;
      • Consulting related to acquisition of licenses and permits;
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      • Trade mark database search;
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      • Representation during disputes related to trade mark infringements;
      • Procedural representation.
      • Representation before the Bulgarian Food Safety Agency and other institutions in relation to registration of commercial properties, various food categories and food additives;
      • Consulting regarding labeling of food products and food additives;
      • Assistance during inspections by authorities, drafting of documents;
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      • Preparation and drafting of commercial contracts, agreements, memoranda and other commercial documents;
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      • Negotiations and deal mediation;
      • Representation before state, municipal, and banking institutions.
      • Legal consulting, research, and analysis;
      • Participation in negotiations;
      • Preparation and drafting of civil, trade, labour and other agreements, memoranda and other documents;
      • Assistance in alternative dispute resolutions to facilitate out-of-court settlements;
      • Representation in court and during arbitration in cases of breach of contract;
      • Consultations on the General Data Protection Regulation /GDPR/;
      • Preparing complete setsof documents for personal data controllers.
      • Legal consulting, research, and analysis;
      • Preparation and drafting of contracts, agreements, memoranda and other documents;
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      • Procedural representation and legal defence in all court instances during commercial, civil, and administrative lawsuits.
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      • Consulting on a current or future cases filed with the Commission for Protection of Competition;
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    With us,
    your corporate legal issues
    will be in good hands.

    Petya Noycheva & Partners Law Office’s goal and mission is to prevent problems from happening before they even arise. We succeed in doing so because we know our clients’ businesses. Our phone lines are always open for you and we will answer all your calls at any time. A first consultation with us is entirely free!

    Swears by Arial Narrow, 11pt.

    Petya Noycheva


    Member of the Sofia Bar Association since 2000

    Co-founder and Partner in Petya Noycheva & Partners since December 2006

    A litigation expert, specialising in negotiations and commercial law

    Petya Noycheva’s legal expertise is in the field of negotiations between companies and clients’ negotiations with banks, institutions, and state authorities. Ms. Noycheva has a solid experience in conducting negotiations in countries from the European Union, Switzerland, the Middle East – such as Iran, UAE, Qatar, Kuwait, as well as in the USA, China, Japan, and others. Her success in developing negotiation strategies and holding commercial and legal talks with a wide range of business clients has contributed to her excellent reputation in international legal practice.

    Petya Noycheva is an expert in contract law and preparation of commercial agreements.

    She works in cooperation with local and foreign law offices, which specialise in different areas of law, and if needed, she assists in finding appropriate consulting services from law experts in Bulgaria and/or abroad, supervising a specific case until its successful completion.

    Ms. Noycheva is fluent in English.

    In her spare time she likes travelling and playing tennis.

    +359 2 958 23 38 | +359 888 640 973 |
    Bulgarian, English


    Andon Nastev


    Member of the Sofia Bar Association since 2006

    Co-founder and Partner in Petya Noycheva & Partners since December 2006

    A specialist in the field of contract law, industrial property law and procedural representation

    Andon Nastev has specialised in contract law. He has considerable expertise in drafting commercial contracts, including agreements under the Law on Copyright and Neighbouring Rights.

    Industrial property and more precisely trade marks are the legal area Mr. Nastev focuses on. He provides consulting, registration, and protection for your trade mark.

    Andon Nastev is the Bulgarian lawyer who was among the first to initiate (in compliance with the 2008 Civil Procedure Code) a reference for preliminary ruling from the Court of Justice of the European Union regarding an interpretation of Article 5 of the First Council Directive 89/104/EEC to approximate the laws of the Member States relating to trade marks, including an interpretation of the term “import” within the meaning of Article 5(3)(c) of the Directive.

    Mr. Nastev is a registered representative of industrial property in the field of trade marks, entered under Nr. 476 in the Industrial Property Representatives Registry at the Patent Office of the Republic of Bulgaria.

    Andon Nastev is also a European Representative of Industrial Property in the field of trade marks, registered with the European Union Intellectual Property Office under registry entry Nr. 69916 of the registered industrial property representatives with the European Union Intellectual Property Office.

    Andon Nastev works in cooperation with local representatives of industrial property for countries from Europe, the Middle East, and Asia. If foreign national trade marks are to be registered, Mr. Nastev provides assistance and acts as a mediator between a client and foreign intellectual property offices, monitoring the process of registration until the procedure is successfully completed.

    Andon Nastev can advise you on the requirements of the General Data Protection Regulation /GDPR/ and prepare a complete set of documents for you that fits your business.

    Mr. Nastev speaks English, German, and Russian.

    In his leisure time he enjoys his hobbies – photography, painting, and ceramic art.

    +359 2 958 23 38 | +359 885 021 029 |
    Bulgarian, English, German, Russian

    Knows who killed Laura Palmer.

    Ginka Dimitrova


    Member of the Sofia Bar Association since 2010

    Ms. Dimitrova began her career at Petya Noycheva & Partners in 2007 and became an associate attorney in 2010.

    She is an expert in food legislation, the laws on food supplements and medical devices and equipment.

    Ginka Dimitrova has focused her professional interests in the area of food safety legislation as this legal sphere is currently being developed in Bulgaria. She has specialised in European food legislation by attending a number of trainings and discussions in the field, including meetings with Bulgarian food safety authorities. She has submitted proposals for the introduction of changes in the food legislation in Bulgaria.

    Ms. Dimitrova is a consultant on medical devices and equipment legislation. She is a highly qualified and experienced lawyer in activities related to registration, labeling and market placement of medical supplies and equipment of any class. She takes part in legal trainings about medical devices abroad, including the strategic event held in Dusseldorf, The International Congress on Market Access & Regulatory Affairs in Medical Devices (MARA2016).

    Ginka Dimitrova provides consulting on corporate registration procedures for state and municipal authorities such as the Customs Agency, the Bulgarian Food Safety Agency, the Bulgarian Drug Agency, the Commission for Personal Data Protection, the Commercial Register, the Ministry of Health, the Regional Environmental Protection Agencies, and others. She has a solid experience in resolving various legal issues and has mastered her conflict resolution skills when such situations arise between representatives of the business sector and the state administration.

    Ms. Dimitrova has a personal goal of protecting the right to court representation for all, regardless of their financial and/or social standing. For this purpose, she volunteers as a pro bono legal counsel.

    She is fluent in English.

    In her leisure time she likes reading, travelling, and camping.

    +359 2 958 23 38 | +359 885 44 92 91 |
    Bulgarian, English

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    The New Regulations on Medical Devices – the Challenges for Companies

    By adoption of the new rules governing the legal regulations on medical devices in the EU market the business faced new challenges which they seem will not manage to respond within the required terms. The Regulation of the EU Parliament on Medical Devices (MDR) became effective on 26 May 2017 with a transitional period of three years – until 26 May 2020. This transitional period aims at giving an opportunity for the companies to bring their business in compliance with the new legislation.
    Although this transitional period seems long at first sight, it appears that there are a few companies who are familiar with the new legal amendments, and these who have taken steps on ensuring compliance with MDR are far less in number. It does not concern the business only, but the institutions in Bulgaria too. The lack of publicity about the changes on the part of the governmental authorities may mean bankruptcy for the business of these companies who rely on getting help from the government for consultations in relation to fulfillment of the legal requirements for medical devices.

    Which companies are concerned?

    The shortest answer is all.

    MDR lays under an obligation producers, distributors, importers, authorized representatives to comply with the stricter rules protecting consumers.
    In Bulgaria most of the business dealing with medical devices is performed by distributors and importers, as a company often combines both functions. Till now there was no regulation on the importer’s duties as all companies importing medical devices were considered as wholesalers/distributors. Introduction of the figure of “the Importer” enabled the distinguishing of companies dealing with import and such that have as their scope of business distribution services. This distinguishing is useful in terms of allocation of the duties and liability between the companies.

    What obligations will the Importer has when the MDR becomes effective?

    The Importer is the first party who launched the medical devices in the EU market. Being the first one in the chain, the Importer has the obligation to check:
    – Conformity of the Medical Device – if it has a CE marking and a Declaration of Conformity;
    – If the producer is identified and if there is an appointed authorized representative;
    – If the device is labeled according to the EU and Bulgarian law and if it is accompanied by the required documents, including the newly introduced information about the Importer placed on the device’s label;
    – If there is a Unique Device Identification (UDI) determined by the manufacturer according to the Unique Device Identification System (if applicable only);
    – Check for device registration and obligation for registration of the Importer in the electronic system for generation of the unique registration number.

    Considering the lack of obligations for the importers until adoption of the MDR, what makes an impression here is the clear regulation and the numerous obligations of these parties. The purpose is to ensure traceability of medical devices, diminishing the risk and experience in engaging the responsibility of more parties along the chain.

    What obligations will the Distributor has when the MDR becomes effective?

    The Distributor has similar obligations to these of the Importer. Before starting marketing a medical device, the Distributor shall check:
    – Conformity of the Medical Device – if it has a CE marking and a Declaration of Conformity;
    – If the obligatory information that the manufacturer must provide is available;
    – If the Importer has fulfilled its obligations for device labeling;
    – If there is a Unique Device Identification (UDI) determined by the manufacturer according to the Unique Device Identification System (if applicable only);
    – A new thing here is the regulation of the distributor’s duty for cooperation with the governmental authorities – a duty that existed ‘unwritten’ until its regulation by the MDR.

    Where is the trick?

    The review of the obligations shows that despite of the enhanced engagement of the Importer and the Distributor with respect to the risk control and traceability of medical devices, if they start their preparation on time, most companies may fulfill the MDR requirements.

    Then why there is so much noise about that?

    If you read carefully Article 16 MDR, it will become clear that the lawmaker has created a fiction affecting a huge part of medical device distributors and importers.
    According to the legal regulations, an importer or another individual or corporate entity shall assume the obligations of manufacturers if:
    – it markets a device under its own name, registered trade name or registered trademark, except in the cases where the distributor or importer signs an agreement with the manufacturer, whereby the manufacturer is indicated as such on the label and is responsible for fulfillment of the requirements imposed by the manufacturers according to this regulation;
    – it changes the purpose of use of a device that has already been launched in the market or put into operation;
    – it modifies a device that has already been launched in the market or put into operation so that it may affect the compliance with the applicable requirements.

    Introduction of the legal fiction facilitates the governmental authorities to seek responsibility from a larger circle of subjects without the need for proving any connection between them. For example, if the distributor, branded a device purchased from China with its own mark, could so far rely on default by the manufacturer regarding the device conformity, by introduction of the new rule, the responsibility for default in these obligations falls directly on it, because it itself is considered as a manufacturer.
    The responsibility of the economic operators affected by the regulation is not limited to a formal check for fulfillment of the obligations of a third party.
    This reading of the regulation lays under an obligation the distributors and importers, meeting the respective requirements, to fulfill all obligations of the manufacturer according to the regulation in terms of ensuring device conformity, clinical trials, operating quality system, etc.
    The conclusion is clear – a number of distributors and importers will try to go as they did before, hopefully not to get “caught”, and other will dissolve their business. There is an exit – start working now and prepare for the coming changes. We, Petya Noycheva & Partners, will be glad to assist you on the way to the change and to contribute to your successful business.


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