Medical devices from various sources may be found on the market and their safety if often questionable. As manufacturers of medical devices, protection of human health is of utmost importance to us and to justify our customers' trust, we hold certificates that prove the safety of our sterile and non-sterile products. One such certificate is ISO Standard 13485, which is a prerequisite for quality assurance of medical devices.
What is ISO Standard 13485?
ISO Standard 13485 is an internationally recognized standard for quality management system in the medical devices industry. It specifies the requirements for quality system whereby a company needs to prove its ability to supply medical devices and that appertaining services can consistently meet the customers' requirements as well as comply with the appropriate laws and regulations.
ISO 13485 pertains to medical devices designed for use in humans. The implementation of the standard is important since it ensures that a company has introduced all practices and procedures that guarantee that a product which is put on the market is safe for use. The standard is designed and intended for companies in designing, developing, manufacturing, maintaining and sale of medical devices.
Requirements of ISO Standard 13485 apply to all companies regardless of size. In order to put a medical device on the market, it has to conform to the requirements of the above mentioned standard and of Regulation (EU) 2017/745. In text below we shall explain why this standard exists and how to achieve conformance.
Why is ISO Standard 13485 important?
Implementation of this standard ensures that a company i.e. manufacturer has introduced all practices and procedures within the company – including tracking raw materials from entry to warehouse, education of employees, customer feedback and production monitoring procedures – with the aim that the products that are placed on the market meet the quality standard consistently and at all times and are safe for use.
Primary aim of ISO Standard 13485 is to establish a system that can be fully compliant with legal requirements and quality system requirements.
What is specified by ISO 13485?
Regulation (EU) 2017/745 of the European Parliament and of the Council (further in text MDR) on medical devices, passed on April 5th, 2017, establishes the rules regarding placement on the market and putting into service of medical devices designed for use in humans.
In order to put a medical device to the EU market, it is necessary to prove that a company's quality management system is harmonized with the MDR, which is achieved by compliance with ISO Standard 13485.
With regard to intended use and risks medical devices are subdivided as follows:
- Class I – medical devices with low risk for users
- Class IIa – medical devices with higher risk for users
- Class IIb – medical devices with high risk for users
- Class III – medical devices with highest risk for users
Within the above mentioned classification there are subclasses. The rules for classification of products are stated in Annex VIII of the Regulation.
For Class I of non-sterile devices, with the lowesk risk for patients, Notified Body needs not be involved and it is the manufacturer's responsibility to issue a Statement of Conformity with the MDR. For all other classes of products including Is, it is necessary to engage the Notified Body which, following the certification process, issues a EU certificate. Data regarding the Notified Body can be found in the Statement of Conformity with the Regulation.
What does the certification procedure include?
The procedure in which the Notified Body confirms that a manufacturer is compliant with the Regulation i.e. the certification procedure, includes application for certification with the Notified Body, assessment of the quality management system documentation, checking of technical documentation and audit within the company's premises by the Notified Body.
After issuing of the EC Certificate and ISO 13485 Certificate, functioning of the system is verified once a year by a regular audit of individual parts of the system. After the third year recertification audit for ISO 13485 is carried out and once in a five year period recertification audit for EC Certificate is conducted.
EC certificate is valid as long as compliance with ISO Standard 13485 and with the Regulation is proven on a yearly basis. These audits are important since they indicate our continued effort regarding the maintenance of product quality with the aim to be able at all times to ensure the safety of their use.
Certification for manufacturers with the seat in Croatia
To be authorized to offer their products on the market of the Republic of Croatia, manufacturers of medical devices with the seat in Croatia have to be registered in the Register of Medical Device Manufacturers of the Croatian Agency for Medicinal Products and Medical Devices.
In addition to being registered in the Register of Medical Device Manufacturers (for all legal and natural persons who engage in manufacturing), all legal and natural persons dealing in the sale of medical devices have to be registered in the appropriate Register within the Croatian Agency for Medicinal Products and Medical Devices (Wholesale of Medical Devices, Medical Devices Retail).
By meeting the above mentioned regulatory requirements, a person or company obtains an approval for putting medical devices on the EU market and thereby on the market of the Republic of Croatia and acquires a guarantee of quality for the devices and for their safety for human health. Audit concerning the compliance of medical device manufacturers with ISO Standard 13485 and obtaining the valid EC Certificate may be conducted by contacting the Notified Body that has been stated as the certificate issue authority.
What does ISO Standard 13485 mean for our medical devices?
Our non-sterile products are Class I and our sterile products, except the surgical sets, are Class Is. You can find the complete offer of our products in our product catalogue and you can contact us directly at any time if you wish to know more abour a specific product or its quality. All our products have appropriate certificates proving that we meet the above mentioned requirements for the manufacture of medical devices.
Together with transparency of business operations and quaranteed safety and quality of products, relationship with our customers and adjusting to their needs is of utmost importance to us. In addition to products included in our standard offer, you can therefore order products which meet specific requirements and which we shall gladly adjust to your needs, maintaining the same quality.
