Somewhat unoriginally,

Our first
consultation
is always
free.

'Describe yourself in three words.'

Approachable,
specialized
experts.

Let's cut to the chase now.

CURRENT ISSUES ON MEDICAL DEVICES

    Services

    • 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;
      • Establishing business entities in view of a client’s investment plans;
      • Representation before state, municipal, and banking institutions;
      • Preparation and drafting of documents related to decisions made by the managing bodies of a company.
      • Trade mark database search;
      • Registration of national trade marks, European Union trade marks, and international registrations;
      • Representation before the World Intellectual Property Organization, the European Union Intellectual Property Office, the Patent Office of the Republic of Bulgaria;
      • 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;
      • Court representation during appeals of penal rulings for violations of food safety legislation.
      • Registration, transformation and termination of commercial entities and sole proprietorships;
      • Commercial enterprises deals, transfer of shares, M&As;
      • Preparation and drafting of commercial contracts, agreements, memoranda and other commercial documents;
      • Legal consulting, research, and analysis;
      • Preparation and registration of collateral and securities, registration of special pledges;
      • 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;
      • Legal consulting, research, and analysis;
      • Drafting of labour contracts and job descriptions;
      • Preparation of documentation related to termination of labour contracts, i.e. disciplinary termination, redundancies, mass dismissals, etc.;
      • Court representation in cases of lawsuits in relation to illegal dismissals and voluntary/compulsory redundancy compensations.
      • Legal consulting, research, and analysis;
      • Preparation and drafting of contracts, agreements, memoranda and other documents;
      • Participation in negotiations and closing of contracts, signing of agreements;
      • Court representation;
      • Representation before state, municipal, and banking institutions.
      • Procedural representation and legal defence in all court instances during commercial, civil, and administrative lawsuits.
      • Preparation of court documentation without court representation;
      • Assessment of possible legal risk in filing a lawsuit for a specific legal dispute;
      • Assistance in out-of-court settlements;
      • Procedural representation and facilitation of the receivables recovery process after a court enforceable ruling.
      • Consulting on a current or future cases filed with the Commission for Protection of Competition;
      • Procedural representation before the Commission for Protection of Competition;
      • Research, statements, and consulting on competition law.

    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

    Partner

    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 | noycheva@pnp.bg
    Bulgarian, English

    Romanticist-in-residence.

    Andon Nastev

    Partner

    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.

    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 | nastev@pnp.bg
    Bulgarian, English, German, Russian

    Knows who killed Laura Palmer.

    Ginka Dimitrova

    Associated Attorney

    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 | dimitrova@pnp.bg
    Bulgarian, English

    Power beyond muscle.

    Dimitar Yanev

    Trainee

    Dimitar Yanev started working for Peya Noycheva & Partners Law Office in 2016.

    He holds a Master’s Degree in Law from the University of National and World Economy, which he graduated with distinction in 2015. While completing his degree, Mr. Yanev took part in and was the winner of national competitions in civil and commercial case studies. He published articles and attended seminars and further trainings in commercial law.

    Dimitar Yanev provides paralegal and technical services to the law office team, participates in drafting all documents and assists in maintaining contacts between clients and partners.

    Mr. Yanev is interested in specialising in commercial and contract law, industrial property law, and labour law.

    He speaks fluent English.

    In his spare time he enjoys hiking and mountaineering.

    +359 2 958 23 38 | +359 890 91 11 01 | yanev@pnp.bg
    Bulgarian, English

    News & Articles.

    Apart from the latest legal news, this is where — every two months — an article or a white paper penned by a member of our team will be published. Inevitably, legal matters will be discussed but those shall invariably be of at least some practical relevance to our clients and prospects. The objective of the articles section is indeed to strip the burning legal issues of the day from the legalese and make them comprehensible.

    CURRENT ISSUES ON MEDICAL DEVICES

    The World Congress on Regulatory Affairs for Medical Devices (RAMD 2017)

    /a brief review/

     

    On 15 – 16 May this year Amsterdam, the Netherlands, was the host of The World Congress on Regulatory Affairs for Medical Devices (RAMD 2017. The Congress discussed various current issues on medical devices, including the traditional topics regarding the development and marketing and efficiency in medical devices, issues related to the follow-up supervision by the regulatory authorities and the key points on introduction to and compliance with the institutional requirements. Some brand new topics were presented related to medical devices, such as e-labeling and medical software.

    Most of the lecturers paid a special attention in their presentation to the recently adopted regulation on medical devices in the EU, namely – Regulation (EU) 2017/745 of the European Parliament and the Council of 5 April 2017 on medical devices (MDR). The Regulation entered into force on 26 May 2017 with a transitional period of its application for three years. Unlike all currently operating directives, which each Member State is entitled to implement into their legislation in their own manner, this Regulation operates and is applicable directly in the Member States. Its adoption is part of the common EU policy focused on unification of the legislation of the different countries in order to achieve better stability, efficiency and transparency in the Union. The new legal solutions are stricter in defense of consumers, but they assume more serious financial and documentary business preparation, as well as an expectation for more severe follow-up supervision on medical devices already launched in the market.

    There are a few key changes in the MDR that make it distinct from the previous legal regulations (directives).

    The most significant change concerning manufacturers, merchants, importers and distributors of medical devices is the legislative decision on recertification of all medical devices. Recertification of medical devices will be done following the new rules under stricter terms and conditions, control and higher requirements to devices. A positive aspect here is the long transitional period for fulfillment of these requirements. The certificates issued by notification bodies under the directives 90/385/EEC and 93/42/EEC before 25 May 2017 (MDR became effective on 26 May 2017) will remain valid until expiry of the term indicated on the relevant certificate, except for the certificates issued in accordance with Annex 4 to Directive 90/385/EEC or Annex IV to Directive 93/42/EEC, which will become invalid on 27 May 2022 at the latest. The certificates issued by notification bodies under Directives 90/385/EEC and 93/42/EEC, as of 25 May 2017 will stay valid until the end of the period, as indicated on the relevant certificate, which does not exceeds five years after issuance. However, the certificates will become null and void on 27 May 2024. Devices that have been legally marketed under directives 90/385/EEC and 93/42/EEC before 26 May 2020, which have been launched in the market since 26 May 2020 on the basis of a certificate as mentioned above, may keep being marketed or put into operation until 27 May 2025. For example: if your medical device was launched in the market under directives 90/385/EEC and 93/42/EEC and was certified on 20 April 2017, valid for 4 years, then the certificate is valid for the entire period indicated there and is complied with the legal requirements.

    Good advice for business: In case that you decide to benefit from the previous legal regulations, you had better obtain a certificate right before 26 May 2020 valid for at least four years – thus you will benefit as long as possible from the previous period. The next big change is the establishment of a unified EU database for medical devices (EUDAMED). The main objectives of EUDAMED are: informing the public about the devices launched in the market, certificates and economic operators; monitoring medical devices in the market and making their identification easier, knowledge about clinical trials and economic operators about their obligations. A positive aspect of EUDAMED is not only the better transparency for the public but helping business too.

    For example – verifying a certificate or a potential partner in the database will need just to log into the system account. The term for the establishment and full functioning of EUDAMED is 26 May 2020. Now some functional rules are expected to be adopted and it is assumed to make it clear what are the obligations of the economic operators with respect to the database. A key change concerning directly all economic operators is the definition of obligations of manufacturers, authorized agents, importers, distributors and persons in charge of compliance with the legal requirements. The unclear points and gaps existing now in the legal regulation of obligations are substituted by strict rules and liabilities.

    Tightening the regulatory procedures assumes more liabilities and difficulties for the economic operators. So for example, to launch a medical device in the market, device importer should check if CE marking has been placed and its EC declaration of conformity has been issued, that all necessary information is available, labeling, that the manufacturer is identifiable and if there is a designated authorized agent. In case of failure to fulfill any of the above requirements, importer will not be allowed to market the medical device at all.

    In conclusion, it may be noted that the EU market of medical devices will face large challenges in the near future. It will require an action plan, strategy and a lot of work in order to keep the quality articles in the market and responsible economic operators. It will be our pleasure to accompany your business on your way to success.

    The End

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    Office

    15 Doyran Street
    Entrance B, Floor 4, Office 9
    Sofia 1680, Bulgaria
    telephone +359 2 958 2338
    fax +359 2 858 6142
    email office@pnp.bg