Certification of Medical Devices, ISO 13485

Medical device certification is a procedure for verifying that medical devices comply with the requirements of technical regulations and standards. It involves the assessment of documentation, manufacturing, quality control, and product safety, taking into account the product’s risk class.

Different assessment schemes apply to different categories of devices. Self-declaration applies to Class I medical devices, while certification applies to Class I (sterile/with a measuring function), IIa, IIb, and III. Products cannot be sold without confirmation of compliance.

ISO 13485 is an international standard for quality management systems for medical devices. It establishes requirements for manufacturers of medical equipment and components and ensures control over all stages of a product’s life cycle.

The standard is based on the principles of ISO 9001 but is adapted to the specific nature of the medical field, covering design, manufacturing, storage, and distribution.

In Ukraine, the standard serves as the basis for compliance with the European MDR regulations.

ISO 13485 is one of the requirements for successfully obtaining medical device certification, entering international markets, and obtaining CE marking. The implemented system is mandatory for manufacturers of medical devices. ISO 13485 certification demonstrates process consistency and risk management, helping to build trust among partners and regulatory authorities.

The “turnkey” certification procedure for Ukrainian-manufactured medical devices consists of several stages, each with clear requirements. The process includes preparation by the company and an independent assessment.

Key stages of certification:

1. analysis of operations and determination of the scope of certification;
2. development of technical documentation for medical devices;
3. implementation of the ISO 13485 quality management system;
4. conducting tests;
5. preparation of documentation for the Ukrainian market (declaration, labeling, instructions, etc.);
6. certification audit by an accredited body;
7. obtaining an ISO 13485 certificate and a certificate of conformity for medical devices in accordance with the Technical Regulation (these two certificates can be obtained simultaneously to save time)

Certification procedure for imported medical devices in Ukraine:

1. review of the manufacturer’s documents to ensure their completeness;
2. signing a power of attorney for an authorized representative in Ukraine;
3. preparation of documentation for the Ukrainian market (declaration, labeling, instructions, etc.);

4. certification audit by an accredited body;
5. obtaining a certificate of conformity for medical devices in accordance with the requirements of the Technical Regulations

A certificate of conformity issued under the standard procedure for medical devices is valid for 5 years, provided that annual surveillance audits are conducted (in certain cases, batch certification or a recognition procedure may apply).

An ISO 13485 certificate is issued for a period of three years. During this period, annual surveillance audits are conducted to confirm the stability of the quality management system. In the absence of nonconformities, the certificate remains valid. Upon expiration, recertification is required.

To certify medical devices, you must prepare a complete set of documents confirming compliance with the requirements of standards and regulations:

• Technical file for medical devices
• Test reports
• ISO 13485-compliant quality management system
• Documents for the Ukrainian market (declaration, labeling, instructions, etc.)

Our company specializes in the certification of medical devices and the implementation of ISO 13485 in collaboration with trusted, accredited certification bodies in Ukraine and the EU.

Our consultants have practical experience in the medical industry and provide professional guidance throughout the entire medical device certification process.

We support our clients from the preparation stage through to obtaining the certificate, minimizing the risk of rejection and repeat audits.

To request certification of medical devices, simply submit an application, after which we will conduct an initial consultation and assess your readiness.

Next, we develop a plan for preparing and implementing the necessary documentation and schedule a certification audit.

The medical device certificate is issued after all required documents have been submitted and the production audit has been completed—thus confirming compliance with the Technical Regulations.

Is certification of medical devices mandatory in Ukraine?
Yes, a certificate of conformity is required for the legal distribution of medical devices.

Who issues the certificate of conformity for medical devices and the ISO 13485 certificate?
The certificate is issued by an accredited certification body following an audit.

How does ISO 13485 differ from ISO 9001?
ISO 13485 takes into account the specific safety requirements for medical devices.

Is certification required for imported medical devices?
Yes, imported products must also undergo registration and certification as medical devices.