CE marking

EC Directives provide for legal grounds for the introduction of medical product into trade in Europe:
• 93/42/EEC for medical devices (MDD)
• 90/385/EEC for active implantable medical devices (AIMD)
• 98/79/EC for in-vitro diagnostic medical devices (IVDD)

As a manufacturer you can introduce into trade medical devices in the European market only when you get conformation that all requirements of a respective directive have been fulfilled. Being one of few “Notified Bodies” we will help you with carrying out your procedure of conformity assessment for all directives connected with medical devices in order to obtain the CE marking, and we will also cooperate with you in obtaining approvals binding in the world for your medical devices. We invite you to use the wide range of our services.
Basic steps needed to obtain the CE marking for medical devices involve:

1. Definition of the purpose of a medical device
As the manufacturer you define the purpose of your medical product. It translates into the decision on the directive which applied to your medical device (MDD, AIMD or IVDD).

2. Classification of a medical device
In MDD a medical device is classified according to regulations in Annex 9. AIMD does not introduce any classification. IVDD distinguishes products as for self-testing, for working assessment, products from List A or B and products not included in any of the above-mentioned categories.

3. Definition of a proper procedure of conformity assessment
Depending on the classification of a device the presence of a “Notified body” is needed to e.g. carry out a test of a medical device type, assessment of project documentation and/or making your quality management system undergo an audit. Products included in the AIMD directive always require participation of a “Notified Body”.

4. Technical documentation
A manufacturer is obliged to prepare technical documentation for each type of a medical device, which as a rule contains the following product documentation: device description, project documentation, relevant norms and description of solutions accepted in order to fulfill basic requirements, risk analysis, reports on performed tests, clinical assessment, labels and instructions of use and additionally, in case of sterile products, a description of sterilization procedure and certification of its validation.
Medical devices must comply with relevant requirements specified in Annex I of an applicable directive. To support the procedure of conformity assessment it is necessary to submit proof of fulfilling security requirements and requirements of technical conformity. Proof of medical effectiveness must be presented in clinical assessment. A manufacturer is free to select any measures to prove that basic requirements have been fulfilled.
As a body carrying out tests of medical devices we can conduct for you necessary testing such as: security tests, functional tests and biocompatibility tests. We carry them out chiefly in our own laboratories. The obtained test results can be used as proof of conformity in technical documentation. .

5. EC test or device design assessment
For all AIMD devices, class III MDD and devices from List A IVDD a manufacturer is to make a decision on carrying out a EC test or a decision on assessment of design dossier. As your “Notified Body” in this process we test a device and evaluate its documentation or design dossier. After successful assessment our certification body issues an approval of conformity with a directive.

6. Implementation of conformity assessment procedure
In many cases a manufacturer of medical devices selects a procedure including an audit of its quality management system. Before the audit auditors assess the quality system management documentation and verify its implementation during the audit on the company premises. Audit duration and the number of auditors depends on the size of a company and diversity and type of products and is defined on an individual basis as a tailored offer. After the audit a company receives a report containing information on its results.
A procedure of EC verification (tests of taken samples or respective product items) may be an alternative for an audit in accordance with Annex IV (MDD) or Annex VI (IVDD). If the procedure of conformity assessment ends favourably our certification body issues an approval of conformity with a directive which will allow for marking your products with CE marking.