News on medical devices
In result of the monitoring of technical-medical units work, certified by the Minister of Health or under approval, that also have certified and implemented Quality Management System SR EN ISO 9001:2008 or SR EN ISO 13485:2004 with certifying bodies accredited by a national accreditation body (the RENAR- Romanian Accreditation Association or similar), as well as of consultations and dialogue conducted with part of these certifying bodies, the NAMMD Department for Evaluation of technical-medical units specifies a follows:
-The field of medical devices is regulated by European directives (93/42, 98/79, 90/365) and, based on Article 6 of Law No.176/2000 on medical devices, as republished and amended, as well as of Order of the Minister of Health No.1636/2007, as amended, the NAMMD performs evaluation of organizations providing services in the field of medical devices (medical optics, orthopaedic/hearing/other type prosthetics or repair, verification and setting into operation of medical devices);
-The NAMMD “sets up specific technical procedures in medical devices”, “on Ministry of Health request, it evaluates and/or audits legal and natural entities applying for approval of operation” (Article 7 of the law mentioned above) and prepares the assessment report based on which the Ministry of Health grants such approval (Article 2 (2) of Order of the Minister of Health No.1636/2007);
-The assessment report prepared by the NAMMD confirms that the natural or legal person seeking approval of operation meets all the working conditions, technical-material endowment, qualification, capability, procedures and instructions to perform that activity.
Long term monitoring of the quality of services rendered by medical devices service providers has shown the NAMMD that not all can prove capacity to provide services consistently meeting both customers’ expectations and regulatory requirements applicable to this field. In that respect, certification of the quality management system has proved imperative, as proof of meeting such requirements.
Given that activities assessed are conducted in the field of medical devices and have serious implications on public health, based on legislation in the field and taking into account the limited number of accredited bodies in Romania for certification of the quality management system according to SR EN ISO 13485 (specific to medical devices), and that most bodies accredited for SR EN ISO 9001:2008 certification do not employ technical experts and auditors qualified and experienced in medical devices, in order to ensure compliance of work by medical devices service with requests of such standards, the NAMMD has prepared its own assessment technical procedure.
The institution has not sought control of such activities, but only to ensure their conduct by suitably qualified personnel.
Whereas CAEN Codes 3313, 3314 and 332 codes do not make explicit reference to repair, verification and start-up of medical devices, and NAMMD experience has not found that auditors/experts of audit teams are at all times acquainted with laws specific to the field, a procedure for approval of certifying bodies has been found necessary; therefore, the response of certifying bodies has been difficult to understand, inasmuch that the NAMMD only target had been a more thorough analysis of compliance with specific requirements in the field.
As an approach that has been misunderstood, the procedure for approval of certifying bodies for assessment of technical-medical units has been discontinued; in that respect, only the requirement concerning the quality management system certification by an accredited certifying body has been maintained.
As before, evaluation of technical-medical units applying for grant of approval for operation, as well as surveillance assessment of these units are currently conducted by the NAMMD-EUTM Department, based on a procedure of its own.