RISE offers expertise and testing to meet regulatory requirements for medical devices

During the pandemic, at the same time as pressure has mounted on laboratories around Europe, there has been an increasing need to test facemasks entering the market, leading many Swedish manufacturers and importers to turn to RISE for assistance.

– “They have discovered the major logistical advantage of having expertise available here at home. Not only is it much easier to drop by and deliver items for testing than sending them abroad, but we are also fast, both in performing the work and in communication,” says RISE director of unit Sara Bogren.

New regulations from May 26th

The new EU Medical Device Regulation enters into force on 26 May 2021. The term medical devices is a broad one, ranging from medical apps to compresses, contact lenses, syringes, needles, drug pumps and other types of implants. These products are also used by individuals for self-treatment and as everyday aids.

Among other things, the new directive increases requirements for evaluation and tightens regulations for manufacturers’ quality assurance systems, risk-management processes and monitoring.

– “There are also stricter requirements for clinical data regarding a product; the possibility of using data from similar products will be limited. This may mean that companies need to carry out their own new studies, something that we can offer support with,” says RISE research scientist Josefin Caous.

Validated instructions required

There are also new requirements for the inclusion of validated instructions for cleaning, disinfecting and sterilising reusable products.

– “Until now, this has not been such an explicit requirement and many manufacturers have continued to use old instructions even after developing or replacing their products,” says Josefin Caous.

RISE performs this type of validation and collaborates with healthcare providers to create the most functional and uniform instructions possible.

Having a testing partner in Sweden makes it easier for manufacturers of medical devices to manage the new EU regulation. RISE has prepared for the new directive by broadening its organisation and competences.

– “We are an extremely agile, flexible organisation that can quickly adapt. Within RISE, we have the background knowledge required to quickly understand and meet our customers’ needs,” says Sara Bogren.

Broad expertise and unique test methods

RISE’s testing operations in the field of medical devices have long been based on a broad base of expertise and experience.

– “We have been assisting researchers, startups and larger companies with various types of testing and studies for a long time now,” says Josefin Caous.

This work involves measures such as testing the effect of a product, material characterisation, strength testing, preclinical tests and all preparations for clinical studies. RISE is the only laboratory in Sweden to offer external customers cell-based testing methods in accordance with OECD principles of Good Laboratory Practice (GLP).

In order to meet EU requirements. all medical devices must undergo biological testing to ensure that the products are safe when coming into contact with patients and healthcare professionals. The RISE laboratory can assist in everything from drawing up a biological safety plan in accordance with different standards to performing the necessary tests.

– “We test everything from plasters to implants and offer both basic testing and specialised tests.” says Kristina Fant, a researcher at the laboratory.

Among other things, tests check for any leakage from products and whether they may cause damage to human cells.

Replacing animal testing

The RISE laboratory also develops and validates testing methods that can replace animal testing.

– “We drive development in the field through various collaborations. This is important as we need to make the best possible assessment when it has consequences for people. Animals and people are different,” says Kristina Fant.

Kristina Fant is keen to point out that RISE does not simply perform tests but is a partner that works closely with the customer at all stages.

– “We can also help in the development stage, performing the necessary tests and offering further assistance once the testing process is complete. We are committed to always providing the customer with added value,” she emphasises.