Along with the beginning of the COVID-19 pandemic, several companies have decided to reinvent themselves and started to produce protective equipment, masks, protective costumes, medical equipment etc.
The reorientation of companies can have various influences such as the desire to help citizens, or the rescue of their own business, but one thing is certain, namely that a conversion of the object of activity to make medical equipment needed during this period of time is an initiative benefic to all and a lifeline for some companies.
Generally, in order to be able to launch medical devices on the market, the producers must go through the conformity assessment procedure. By derogation from this rule, upon justified request, those interested will be able to produce medical devices if their use is in the interests of health protection, even without carrying out the mentioned procedure, that is without the CE marking.
Consequently, in order to resolve as quickly as possible the lack of equipment due to the COVID-19 pandemic, the companies interested will be able to place on the market medical devices without the CE marking.
The National Agency for Medicinal Products and Medical Devices in Romania (ANMDMR) shall assess the products and if they comply with the essential health and safety provisions, it will allow them to be placed on the market temporarily or during the conformity assessment procedure.
In accordance with Directive 93/42/EEC, transposed in Romania by Government Decision no. 54/2009, in order to be able to identify a product correctly, its main purpose must be taken into account. If the product is destined to be used in a medical context, in order to ensure the health and safety of the patients, then it may be included in the medical devices category.
The Directive 93/42/EEC also specifies that if a product is manufactured to protect the person using it, it will be covered by Regulation 2016/425 on individual protection equipment, whether it is medical environment or not.
- GENERAL CONDITIONS
u A first step is to register the producer with the National Agency for Medicinal Products and Medical Devices in Romania.
u Required documents:
- Application form;
- Copy of the registration certificate or other official document/regulatory document attesting the constitution of the applicant company and certificate issued by the Trade Register Office from which may result the activity object of the enterprise;
- Producer’s EC declaration of conformity;
- Technical specification;
- Instructions for use of the medical device;
- Medical device label.
u The preparation of a file containing the details of the product, the assessments, design drawings and the manufacturing methods.
u The certificate of registration of the medical product shall be issued within 60 days.
- ONGOING PROJECT
Furthermore, according to a press release, Economy Minister, Virgil Popescu, declared that the micro-conversion program will be modified with grants of up to 200.000 euros in order to stimulate the companies on producing the necessary sanitary materials and equipment.
The Law Firm ”Christian Bogaru” (BCHLAW) is an international law firm, being ranked amongst the 30 most renowned Law Offices in Romania, having an established experience in International Business Law, with internationally trained lawyers that have a vast and sustained experience in different legal fields, essential for starting, developing, operating a business in Romania and in Eastern Europe. The Law Firm ”Christian Bogaru” has strong assets, such as Romanian and Francophone lawyers, proficient speakers in English, with legal qualification in several European jurisdictions, consolidated legal expertise in several fields of law (corporate law, labor law, mergers and acquisitions, taxes, real estate, transport, criminal business law, GDPR etc.) assisting and representing foreign and Romanian companies of all sizes and reputations ( Multinationals, SMEs, etc.)