Medical Devices Questionnaire
Published in Lex Mundi, 2010
1. Definition of medical devices
What is the definition of a medical device in your jurisdiction?
[A.1.] A medical device is defined under the provisions of Government Decision no. 54/2009 regarding the conditions for the placing on the market of medical devices, (“GD 54/2009”), which implements among others the Council Directive 93/42/EEC of 14 June 1993 concerning medical devices, as any instrument, apparatus, equipment, software, material or any other article, used separately or in combination, including the software intended by its manufacturer to be used specifically for diagnosis and/or therapeutic purpose and necessary for the proper functioning of the medical device, intended by the manufacturer to be used for human beings for the purpose of:
(i) diagnosis, prevention, monitoring, treatment or alleviation of a disease;
(ii) diagnosis, monitoring, treatment, alleviation or compensation of an injury or a handicap;
(iii) investigation, replacement or modification of the anatomy or of a physiological process;
(iv) control of contraception,
and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means.
This definition, which apparently implements the definition of medical devices from the English language version of the Directive 93/42/EEC, might be viewed, to a certain extent, unclear, at least with respect to its last part. Therefore, in our view and considering the French language version of this directive, the last part of the definition should be read in the sense that an instrument, material, etc. enters into the sphere of definition of a medical device if its principal intended action in or on the human body is not obtained through pharmacological, immunological or metabolic means, but may be assisted instead with respect to its functionality by such instrument, material, etc.
GD 54/2009 provides separate definitions for in vitro medical devices, custom-made medical devices, medical device made for clinical investigation, medical device for a single use and the accessories to medical devices which are treated as medical device.
2. Combination products
i. Which legal regime (on medicinal product or on medical devices) applies to combination products incorporating both medicinal products (drugs/biologics) and medical devices?
[A.2.i] In case the medical device is meant for the administration of a medicinal product as defined by Law no. 95/2006 regarding the reform in the health field, as further amended and supplemented, (“Healthcare Law”), namely any substance or combination of substances presented as having properties for the treating or preventing diseases in human beings or any substance or combination of substances that might be used or administrated to human beings, either with a view to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or for making a medical diagnosis, the said device is regulated as a medical device in the sense of the applicable legislation, without however affecting the applicability of the Healthcare Law in what concerns the medicinal product.
Should a device be placed on the market in a form in which the device and the medicinal product form a single complete product, which is intended exclusively for use in the given combination and which can not be reused, this sole product is regulated by the Healthcare Law. The relevant essential requirements regarding the medicinal devices as provided by the applicable legislation would be applicable in the latter case only in what concern the security characteristics and its performances.
In case a device incorporates as an integrant part a substance which, if used separately, may be considered as a medicinal product as defined by the Healthcare Law, and which can act upon the human body through an auxiliary action to the medical device, such is evaluated and authorized as a medical device in accordance with the applicable legislation. Also, in case the medical device incorporates as integrant part a substance which, if used separately, may be considered as a constituent part of a medicinal product or a medicinal product derived from blood or human plasma as defined by the Healthcare Law, further named as human blood derivatives, and which can act upon the human body through an auxiliary action to the medical device, such will be evaluated and authorized as a medical device in accordance with the applicable legislation.
ii. Are combination products (combining drugs and medical devices) subject to separate regulation in your jurisdiction?
[A.2.ii] Please refer to the above answer A.2.i.
iii. If the answer to (i) is negative, what is the scope of application of the legal regimes:
evaluating both the drug and device components of the combination product?
[A.2.iii] Please refer to the above answer A.2.i.
iv. What are the general conditions for review, approval and marketing the combination product?
[A.2.iv] Please refer to above answer A.2.i.
3. Borderline products
Are there any official and binding criteria for determination whether the product is a medicinal product or medical device, or whether a product is a device requiring pre-review or a non-medical device?
i. Are there any legal and binding criteria for determination whether the product is a
medical device or medicinal product?
[A.3.i] Please refer to above answer A.2.i.
ii. If the answer to (i) is positive, what are the main principles for differentiation?
[A.3.ii] Please refer to above answer A.2.i.
iii. Are there any significant court or administrative judgments demonstrating the rules of product differentiation?
[A.3.iii] We are not aware of any such decisions.
iv. How is software that may have some related-medical applications regulated in your
[A.3.iv] Please refer to the above answer A.1 regarding the definition of the medical device, according to which a software may be viewed as a medical device in certain conditions.
4. Cellular or tissue based products
Are there any official or binding criteria for determination whether a product is a animal or human based tissue or a medical device?
[A.4.] As a general note, the legislation regarding medical devices is not applicable to:
- human blood, blood products, plasma or blood cells of human nature or the devices that incorporate as of the moment of their placing on the market such products from blood, plasma or cells, except for the devices that incorporate as integrant part a substance which, if used separately, may be considered as a constituent part of a medicinal product or a medicinal product derived from blood or human plasma as defined by the Healthcare Law, further named as human blood derivatives, and which can act upon the human body through an auxiliary action to the medical device, which are evaluated and authorized as medical devices in accordance with the applicable legislation;
- transplants, tissues or cells of human nature, as well as the products that incorporate or derive from tissues or cells of human nature, except for the devices that incorporate as integrant part a substance which, if used separately, may be considered as a constituent part of a medicinal product or a medicinal product derived from blood or human plasma as defined by the Healthcare Law, further named as human blood derivatives, and which can act upon the human body through an auxiliary action to the medical device, which are evaluated and authorized as medical devices in accordance with the applicable legislation;
- transplants, tissues or cells of animal nature, except for the cases in which a medical device us made through the use of nonviable tissues of animal origin or of nonviable products, derived from tissues of animal origin.
i. How are products composed of cells or animal/human tissue regulated in your
[A.4.i] Please refer to the above answer A.4.
ii. Are there any legal and binding criteria for determination whether the product is a
medical device or cellular/tissue based product?
[A.4.ii] No, the legislation regarding medical devices does not provide any other criteria than the ones mentioned in the above answer A.4.
iii. If the answer to (ii) is positive, what are the main principles for differentiation?
iv. Are there any significant court or administrative judgments demonstrating the rules of product differentiation?
[A.4.iv] We are not aware of any such decisions.
5. Admission to trade of medical devices
What are the requirements for admission (import) of medical devices into trade?
[A.5] The general requirements for medical devices to be admitted into trade is for such to comply with the essential safety and health conditions imposed by the law and to have the CE marking.
i. Is clinical assessment required for admitting (importing) medical devices into trade?
ii. If the answer to (i) is positive, are clinical trials required or is there an alternative basis for clinical assessment?
iii. Is certification by an external certifying body required for compliance assessment of medical devices, or is a manufacturer’s declaration of conformity sufficient?
[A.5.iii] For certain medical devices, the procedure for the evaluation of conformity implies the intervention of a notified body. As a general note, the notified bodies designated by the Ministry of Health in relation to the evaluation of the conformity procedure are notified by the latter to the European Union Member States and to the European Commission together with their specific tasks and the identification numbers prior attributed by the European Commission.
The list of the notified bodies and their attributed identification number as well as their specific tasks for which such have been notified are published in the Official Journal of the European Union which should be permanently updated, according to the law.
iv. Is administrative pre-clearance or pre-approval of medical devices required for admission of medical devices into trade, or is post-launch notification sufficient?
[A.5.iv] The manufacturer or the authorized representative of the manufacturer established in Romania has the obligation to register itself when he places on the market the following types of medical devices:
a. Class I medical devices, including the sterile ones and/or with measuring function;
b. Custom made medical devices and active implantable custom made medical devices;
c. Systems and packages of procedures as provided by Article 29 of the GD 54/2009;
d. In vitro diagnostic devices.
Based on the documents filed in accordance with the legal provisions, the competent direction from the Ministry of Health registers in the data base the information regarding the medical devices placed on the market and the information regarding the persons responsible for their placing on the market and issues to the applicant a certificate for the registration of the medical devices. Any modification that appears after the issuance of the certificate for the registration of the medical devices, including the interruption of placing on the market of the registered medical devices, has to be notified. All the modifications are mentioned in an annex to the registration certificate of medical devices.
Also, the manufacturer, the authorized representative of the manufacturer, the importer and the distributor established in Romania has the obligation to notify the Ministry of Health the putting into function in Romania of the following types of medical devices:
a. Medical devices from classes IIa, IIb and III;
b. In vitro diagnostic devices that make the object of Annex 2 to the Government decision no. 798/2003 on the establishment of requirements for placing on the market and use of in vitro-diagnostic devices;
c. In vitro diagnostic devices for self testing;
d. Active implantable medical devices.
The competent direction from the Ministry of Health registers all the data that allows the identification of the medical devices put in function in Romania.
The import of medical device is made based on the following documents:
a. Conformity declaration of the manufacturer, in which has to be mentioned the conformity of the imported medical device with one of the following directives: Directive 93/42/CEE; Directive 98/79/CE or the Directive 90/385/CEE;
b. The customs approval in the format provided by annex 4 to Order no. 253/2010 regarding the registration of medical devices issued by the Technical Office of Medical Devices, which is issued only for certain types of medical devices.
6. Processing of personal data (privacy)
What are the rules of processing of personal data in a number of activities performed by manufacturer/s distributors/ healthcare units with the use of medical devices.
[A.6] The general provisions of Law no. 677/2001 regarding the protection of individuals with regard to the processing of personal data and the free movement of such data, which implements Directive 95/46/EC are applicable. In case a detailed presentation of such rules is necessary, we remain available to provide it.
i. Are there any specific rules protecting the privacy of personal data of consumers
purchasing medical devices, by manufacturer/distributors?
[A.6.i] Please refer to the above answer A.6.
ii. Are there any specific rules of processing of personal data sourced by means of medical devices containing software, by healthcare units?
[A.6.ii] Please refer to the above answer A.6.
iii. Are there any specific rules of processing of personal data by manufacturers/distributors in case of collecting reports on medical incidents from customers?
[A.6.iii] Please refer to the above answer A.6.
iv. What is the standard for reporting adverse events, and is reporting of events in foreign countries required, and using what standards?
[A.6.iv] The Ministry of Health ensures in a centralized manner the registration and the evaluation of any information that is received regarding the reporting of incidents, as provided by the law, in relation to medical devices from classes I, IIa, IIb and III. The obligation to report to the Ministry of Health these incidents in relation to such medical devices is to be performed by the medical personnel, sanitary units and the manufacturer.
In case the information about certain incidents has been transmitted by the medical personnel, sanitary units or by other users, the Ministry of Health informs the manufacturer of the said medical device or its authorized representative with respect to the incident. After the performance of an evaluation, and if possible, together with the manufacturer or its authorized representative, the Ministry of Health informs immediately the European Commission and the other EU Member States regarding the taken measures or that are considered in order to minimize the risk of certain incidents, including also information regarding secondary incidents.
What is the optimal model of reimbursement of medical devices?
[A.7.] The medical devices may be reimbursed through the health insurance system at the level of the reference price or the rental sum, as the case may be, established through a methodology approved by order of the National Health Insurance House. The providers of medical devices approved by the Ministry of Health, which are permanently evaluated, have to conclude agreements within the legal conditions with the health insurance house on the basis of the model of agreements provided within the methodological norms for the implementation of the framework agreement regarding the conditions for granting medical assistance within the social health insurance system for each year, as approved through government decision.
i. What are the rules of granting reimbursement of medical devices in your jurisdiction?
[A.7.i] Please refer to the above answer A.7.
Is distribution and promotion of medical devices subject to legal regulation?
[A.8] The distribution of medical devices is specifically regulated by the Romanian legislation, especially by Law no. 176/2000 regarding medical devices, as republished, (“Law 176/2000”), and its implementation norms as approved through Order no. 1636/2004, (“Order 1636/2004”), while for the promotion of medical devices please refer to our answer to question 8.v.
i. Are there any specific regulations determining mode of business activity of medical
[A.8.i] As a general note, the activities of marketing, distribution and service supply in the field of medical devices are performed within the conditions regulated by Law 176/2000 and Order 1636/2004. The natural or legal persons that intend to perform these activities are required to obtain a permit issued by the Ministry of Health. Exception is made by the activities that are performed by the manufacturer of the medical devices that make the object of these activities. The permit has to be issued prior to carrying out the mentioned activities.
According to Order 1636/2004, the medical technical units that may obtain the functioning permit are units that have as object of activity the manufacturing, marketing, distribution and the supply of services in the field of medical devices.
Depending on the specific of the main activities that are carried out, the medical technical units are:
a. Units that manufacture medical devices;
b. Units with an import, depositing and marketing activity;
c. Units with an activity of repair, verification and put into functioning;
d. Units with an activity in the medical optic field;
e. Prosthetics activity units.
The functioning permit is issued by the Ministry of Health based on the documentation required by the law filed by the applicant, the payment of official fees and some cases on the basis of the evaluation and audit report of the unit made by the National Agency for Medicinal Products and Medical Devices.
The units that perform an activity of repair, verification and put into functioning, the units which perform an activity in the medical optic field and the ones with a prosthetics activity are verified every two years by the National Agency for Medicinal Products and Medical Devices through a survey audit in order to ensure that they comply with the conditions of the activity for which the functioning permit has been issued by the Ministry of Health.
Any modification that appeared after the obtaining of the functioning permit has to be notified to the specialized direction from the Ministry of Health.
The pharmacies and drug stores that have a functioning authorization issued by the Ministry of Health according to the law, are not required to obtain also the functioning authorization for the activity of marketing of medical devices.
The medical technical unit designated explicitly by the manufacturer with his headquarters outside the EU as the authorized representative in the European Union registers as the authorized representative of the manufacturer.
In addition to the above, no other requirements are expressly provided.
ii. Is administrative permit for medical devices distribution required?
[A.8.ii] Please refer to answer A.8.i.
iii. Are there any specific limitations in distributing medical devices in your jurisdiction?
[A.8.iii] No, in case the legal conditions are met.
iv. Are obligations of distributors of medical devices specifically legally regulated?
[A.8.iv] Romanian legislation contains provision regarding certain obligations of distributors of medical devices, as mentioned also in the above answers.
v. What specific rules exist for advertising and promoting medical devices?
[A.8.v] Specific provisions regarding the advertising of medical devices are stipulated by the audiovisual legislation.
How are manufacturing practices regulated?
i. Are there any specific standards or regulations determining the quality of manufacturing practices?
ii. If the answer to (i) is positive, how are these good manufacturing practices or quality system regulations reviewed and enforced?
iii. Are establishments manufacturing medical devices, or components of medical devices, required to be registered with a government regulator?
[A.9.iii] Please refer to the above answer A.8.i. Also, in addition to the compliance with the corporate and fiscal legislation, any manufacturer with his headquarters in Romania, that places devices on the market under his own name in accordance with the certain provisions of GD 54/2009 regarding class I medical devices and the custom made medical devices and any other natural or legal person that carries out the activities provided by GD 54/2009 regarding the systems and procedures packages have the obligation to register with the Ministry of Health, by providing data with respect to the address of the social headquarters and the description of the devices that make the object of their activity for the purpose of introducing these in the national data base regarding medical devices of the Ministry of Health.
For all medical devices of classes IIa, IIb and III, the Ministry of Health shall be informed about all the data that allows the identification od the devices together with the label and the use instructions, when such instructions are put into function in Romania.
Where the social headquarters of a manufacturer that places a device on the market under its own name is not in the EU, the respective manufacturer has to designate a sole authorized representative in EU.
The Ministry of Health informs upon request the other member states of the European Union and the European Commission with respect to the details provided above as supplied by the manufacturer or his authorized representative.
iv. Are these establishments inspected regularly by government regulators or authorized bodies, and what is the mode of such inspections?
[A.9.iv] Please refer to answer A.8.i. Also, please note that, while an inspection is not performed in relation to the manufacturer, the medical devices put into function and the ones in use are submitted to control actions, within the conditions provided by the law.
10. Regulatory Guidance
How are the requirements communicated to medical device manufacturers?
[A.10] By the legislation in force.
i. In what form do the laws and regulations appear that are applicable to medical device manufacturers?
[A.10.i] The relevant legislation and regulations is directly applicable to medical devices manufacturers.
ii. Are informal guidance or the opinions of regulators available to device makers, and in what form?
[A.10.ii] In practice, the manufacturers of medical devices may obtain upon request informal points of view from the competent authorities.