Kiilto’s hospital hygiene products fulfil the strict criteria laid down in legislation. As a pioneer company, Kiilto also contributes to the development of product safety and control. Lately, Kiilto has been busy with the new EU regulation that will enter into force in May.
The new EU Medical Device Regulation will enter into force in May. Medical devices include thousands of products ranging from plasters to pacemakers. They also include detergents and disinfectants for healthcare produced by Kiilto.
Virve Töyrylä, R&D Manager at Kiilto, says that the new Medical Device Regulation (MDR) 2017/745 will harmonise the regulation of the product group within the EU. The previous directive left more room for country-specific applications.
“The starting point for the new Regulation is, first and foremost, patient safety”, says Töyrylä.
CE marking indicates safety
The Regulation requires that manufacturers of medical devices have a quality management system in place.
“Kiilto already has an ISO 13485 quality certificate for medical devices and supplies.”
A CE mark continues to indicate that a product is safe, efficient, and appropriate. In addition to the CE mark, the label will also include an MD symbol indicating that the CE mark refers to a medical device.
Safety assessments and better traceability
The Regulation requires that the manufacturer conduct regular safety assessments.
“In the safety assessments, we periodically check that the product is still suitable for its intended purpose and that it is used correctly.”
In addition, the traceability of products is improved. Products are registered in a new European database using Unique Device Identification.
“A batch ID and best before date must be visible on the product, for example, on the label of a detergent canister. In the future, these must also be provided in a machine-readable format.”
New applications of the CE marking
In the future, Kiilto will certify some disinfectants placed on the Scandinavian market as medical devices that previously did not have that status. This enables the use of the products in healthcare.
“This change applies to some products that have previously been used in other settings and regulated under different legislation. These products will become medical devices when we certify them in accordance with the MDR.”
Also in this case, a CE marking and a MD symbol indicate that the product is a medical device.
Plenty of invisible work
According to Töyrylä, Kiilto has prepared well for complying with the requirements of the new Regulation. She says that legislation requires a lot of work that is invisible to the customers.
“Markets are strictly regulated, and you cannot enter the markets unless you fulfil the required criteria.”
Kiilto monitors legal developments and contributes to these as well.
“We are a member of the Sailab – MedTech Finland association which promotes the interests of Finnish health technology companies.”
Töyrylä herself participates in a working group of a European committee that develops standards for demonstrating the efficiency of disinfectants intended for use in healthcare.
Kiilto provides training on the appropriate use of products
It is not enough to ensure the efficiency and safety of products intended for healthcare with legislation. The products must also be used correctly and as intended.
“Kiilto experts are trained in the appropriate use of detergents and disinfectants. You can always ask us for advice”, reminds Virve Töyrylä.