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Bulgaria: The Effect of the New EU Medical Device Regulation on Bulgarian Legislation

Bulgaria: The Effect of the New EU Medical Device Regulation on Bulgarian Legislation

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In 2010, France’s Agence Nationale de Sécurité du Médicament published the results of tests of breast implants produced by the French company PIP and banned their use, due to an increasing number of reports of incidents related to impaired implant integrity and subsequent health-related complications.

In December 2018, an Irish manufacturer of breast implants and tissue expanders announced that it had suspended the sales of breast implants and had withdrawn its products from the market in the EU Member States. This decision was a result of an order for compulsory withdrawal made again by France’s regulatory authority.

Following the scandal over PIP products, MEPs in the European Parliament unanimously adopted a resolution calling on the European Commission to review existing legislation on medical devices. In 2015, the Permanent Representatives Committee finalized the Council of the European Union’s position on two draft regulations aiming at updating EU rules on medical devices and in vitro diagnostic medical devices. The European Parliament adopted the two regulations on April 5, 2017. Regulation 2017/745 on medical devices will take effect on May 16, 2020, and Regulation 2017/746 on medical devices for in vitro diagnostics will take effect on May 26, 2022.

There are more than 500,000 types of medical devices – including those for in vitro diagnostics – on the EU market, including x-ray machines, pacemakers, breast implants, artificial joints, medical spikes and automatic seams, sutures, contact lenses, etc. In vitro diagnostic medical devices are used in sample testing and include blood tests for HIV, pregnancy tests, and blood glucose monitoring systems for diabetics.

In Bulgaria, the medical device market is estimated unofficially at about 400 million Bulgarian levs (approximately EUR 200 million) a year, and there are over 1000 registered dealers in the country. The National Health Insurance Fund’s budget for medical devices in 2018 was 98 million Bulgarian levs and another 46 million Bulgarian levs were provided for in the budget of the Social Ministry covering the need of medical devices such as hearing aids, wheelchairs, etc.

Until 2016, the Bulgarian Medical Devices Act provided that the State Agency for Metrology and Technical Supervision (SAMTS) is the competent authority for the assessment, designation, notification, and monitoring of medical devices released on the Bulgarian market. However, as of 2016, control over the medical devices has been exercised by the Bulgarian Drug Agency (BDA). Currently, the BDA is responsible for, inter alia: (i) Registering persons who place medical devices on the Bulgarian market; (ii) Issuing permits for conducting clinical trials with medical devices; (iii) Issuing authorizations for the conformity assessment of medical devices, including the evaluation of clinical data in accordance with Implementing Regulation (EU) No 920/2013; (iv) Providing licenses for wholesaling of medical devices; (v) Supervising products placed on the market/in operation on the territory of Bulgaria; (vi) Maintaining a system for recording, analyzing, and summarizing incidents and potential incidents with medical devices; (vii) Maintaining an electronic database of publicly paid medical devices; (viii) Provide information in a standardized format in the EUDAMED European Database; and (ix) Validating information submitted by applicants when registering manufacturers and medical devices in the electronic list of devices that can be paid for with public funds.

Once implemented, Regulation 2017/745 on medical devices will change the law in Bulgaria concerning medical devices, as well as the functions of the BDA. The Ministry of Health is working on drafting an amendment to the Bulgarian Medical Devices Act and has set up an intradepartmental working group on the project. According to official information from the Ministry of Health, the draft amendment to the Medical Devices Act will be published for public consultation before May 26, 2020 – the date for entry into force of Regulation 2017/745. This means that in practice the adaptation of national legislation to the directly-applicable Regulation 2017/745 will likely be delayed. For a certain period of time after May 26, 2020, there might be administrative ambiguity regarding the competencies of the BDA with regard to the registration and placing on the market of medical devices. Therefore, our advice to manufacturers is to keep the above information in mind when planning for the Bulgarian market.

By Elena Todorova, Head of Life Sciences, Schoenherr Sofia

This Article was originally published in Issue 7.3 of the CEE Legal Matters Magazine. If you would like to receive a hard copy of the magazine, you can subscribe here.

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Schoenherr is a leading full-service law firm providing local and international companies stellar advice that is straight to the point. With 15 offices and 4 country desks Schoenherr has a firm footprint in Central and Eastern Europe. Our lawyers are recognised leaders in their specialised areas and have a track record of getting deals done with a can-do, solution-oriented approach. Quality, flexibility, innovation and practical problem-solving in complex commercial mandates are at the core of our philosophy.

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