CONFORMITY ASSESSMENT
The ultimate cost of the assessment (registration) of conformity of a medical device to current Technical Regulations of Ukraine No. 753, 754 is determined individually in each case and depends on many parameters such as: risk class; number of types/modifications; completeness; availability of technical documentation for the device; availability of the product registration in Europe/USA, etc.
The classification of medical devices in Ukraine today is similar to the European classification (Directives 93/42/EC; 98/79/EC), table 1
Table 1 Classification of Medical Devices In Ukraine
| Medical Devices | For in vitro diagnosties(IVD) | |||
| 1 | 1s, 1m | IIa, IIb, III | Other | List А/В/Devices for selftesting |
Further, the risk class determines the conformity assessment procedure:
- self-declaration – for Class I and IVD, or “other” devices, classification
- batch assessment – for Class IIa, IIb devices
- assessment of the manufacturer’s quality system – for Class Is, IIa, IIb, III devices and IVD classification “List A/B/ Devices for self-testing”
SELF-DECLARATION
The manufacturer or Authorized Representative (AR), under a power of attorney, issues the declaration of conformity of the declared medical device to the relevant Technical Regulations of Ukraine. The manufacturer must prepare a set of technical documentation for the device (technical file) according to Annex 8 of Technical Regulations RCMU No. 753 On approval of the Technical Regulation for medical devices). After the declaration of conformity is issued, the manufacturer must notify the authorized bodies of his location and of the medical devices to be marketed (clause 31 of RCMU No. 753; clause 23 of RCMU No. 754 for in vitro).
BATCH ASSESSMENT
The manufacturer or Authorized Representative (AR), under a power of attorney, submits an application to the Conformity Assessment Body (CAB) for the assessment of a batch of a medical device. The CAB reviews the technical file, takes samples, and refers them for relevant testing (electrical safety, EMC, biocompatibility, clinical evaluation). In case of successful completion of all these stages, the CAB issues a certificate for the declared batch.
ASSESSMENT OF THE MANUFACTURER’S QUALITY SYSTEM
The manufacturer or Authorized Representative (AR), under a power of attorney, submits an application to the Conformity Assessment Body (CAB) for evaluating the current quality system of the manufacturer. The CAB conducts work in 2 stages. At Stage 1, the technical file is assessed and, in the absence of comments, the stage is followed by Stage 2, at which the quality system is assessed directly. This can be done by 1-2 auditors visiting the manufacturing site or by recognizing the results of the assessment of a number of European notification bodies (TUV SUD, TUV Rheinland, DEKRA, BSI, etc.). EC certificate with a specified validity period and a list of products is recognized.
The table with the estimated cost of the main conformity assessment procedures is given below.
Table 2 Cost of Conformity Assessment for Medical Devices In Ukraine
| Medical Devices | For in vitro diagnostics (IVD) | |||||||
| 1 | 1s | IIa | IIb | III | Other | List B/Devices for self-testing | List A | |
| SELF-DECLARATION | 800.00 EUR | – | – | – | – | 800.00 EUR | – | – |
| BATCH ASSESSMENT | – | – | 3,000.00 EUR | 3,500.00 EUR | – | – | – | – |
| ASSESSMENT OF THE MANUFACTURER’S QUALITY SYSTEM | – | 5,000.00 EUR | 5,000.00 EUR | 5,000.00 EUR | 6,000.00 EUR | – | 5,000.00 EUR | 5,000.00 EUR |
Our company provides services for drawing up a technical file and its individual modules, taking into account the specifics of a particular medical device. The availability of technical documentation is a prerequisite for marketing medical devices in Ukraine. The prices for the preparation of a technical file for Class I medical devices as the most common in Ukraine are provided below.
TECHNICAL FILE
Table 3 The Cost of Preparing A Technical File For Class I Medical Devices
| TF module | Class I medical devices |
| Instruction for use, label | 400.00 EUR |
| Preclinical assessment results | 400.00 EUR |
| Clinical assessment results | 800.00 EUR |
| Risk analysis | 800.00 EUR |
| Basic requirements, standards used | 400.00 EUR |
| Preparation of a dossier: the structure, the descriptive part | 600.00 EUR |
For details on conformity assessment of medical devices in Ukraine, as well as on the service of Authorized Representative, please contact us.