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Blue biotechnology

Blue biotechnology
blue biotechnology

The blue economy side streams (fisheries, aquaculture) are generating considerable biomasses that are wasted or at best used for low value products. This is unfortunate as the biomass (fish, crustaceans, algae) is rich in precious bioactive components. At RISE, we valorize these renewable components into high value products.

The blue value chain

Marine resources are renewable but inherently limited, so it is crucial to use whatever we harvest as efficiently as possible. In Sweden, about 26,000 tons of seafood processing residuals are generated each year. Today, only half of the side stream biomass from fisheries and seafood processing are, at best, used for low-value purposes such as feed.

At RISE, we can help any actor along the value chain: from seafood and (micro)algae producers that desire increased revenue on their side streams; to product and brand owners that want to replace their fossil-based feedstock with a blue sustainable counterpart or are searching for the next generation functional or bioactive materials

In our flagship initiative MAREFINE, we have brought experts from all parts of RISE to valorize; shrimp, algae, and fish, into high value cosmetic, nutraceutical, textile, and medtech products. A key technology is the biorefinery, intended to extract as many of the valuable components from the biomass as possible. Here, RISE offers both small lab scale testing and full pilot and demo scale refinery processes. To ensure that the refinery and valorization process are both economically and environmentally sustainable, we offer continuous life cycle assessment (LCA) and technoeconomic evaluations throughout the development. At the Kristineberg Marine Research and Innovation Centre in Fiskebäckskil, RISE is part of a large testbed that helps companies to develop new innovative blue value chains.

From marine resource to high value product

RISE has expertise and experience to extract and valorize a range of functional and bioactive components from various types of marine biomasses. Key examples include:

  • Chitin & Chitosan – polysaccharides obtained from crustacean shells, e.g., shrimp and crab
  • Alginate – a polysaccharide extracted from brown seaweeds (kelp), e.g., Laminaria digitata.
  • Ulvan – a bioactive sulfated polysaccharide extracted from green seaweeds (sea lettuce), e.g., Ulva fenestrata
  • Fucoidan – a bioactive sulfated complex polysaccharide from brown seaweeds (kelp), e.g., Saccharina latissima.
  • Carrageenan – a sulfated polysaccharide from red seaweeds (sea moss), e.g., Chondrus crispus
  • Collagen, gelatine and collagen hydrolysate – a fibrous bioactive protein from fish waste (skins, bones, scales) or other animal by-products
  • Byssus (“sea silk”) – a proteinaceous fiber produced by mussels
  • Diatom frustules – the mesoporous silica shells from diatoms, i.e., microalgae
  • Chrysolaminarin – a neutral polysaccharide produced by microalgae to store energy
  • Polyunsaturated fatty acids – bioactive lipids, e.g. omega 3 (EPA and DHA) produced by macro- and microalgae and found in fish
  • Pigments – e.g. fucoxanthin and astaxanthin found in both macro- and microalgae as well as crustacean shells.

 

We develop our high value prototypes and products from the extracted marine components using a battery of manufacturing methods. With respect to textiles for fashion, wound dressings, nutraceuticals, drug delivery vehicles, and scaffolds for regenerative medicine, our key techniques include: 

  • Solution spinning  – RISE has expertise in wet-spinning of biopolymers, from lab, pilot, to demo scale. Our workshop in Mölndal encompasses the entire value chain: from fiber development; via either continuous filaments or staple fibers including; cutting, crimping, carding, and yarn spinning; to knitted textiles.
  • Solution blowing – A nonwoven fabrication technique that combines the versatility of electrospinning with the scalability of melt blowing. Can be used to design wound dressing, superabsorbents, filtration, and biomimicking tissue engineering scaffolds.
  • Formulations and controlled release – many bioactive ingredients from marine biomass (e.g. antioxidant pigments from algae, fish oils, vitamins, and bioactive peptides) are most useful when encapsulated for protection and/or controlled delivery. In other cases, the marine-derived component can constitute the entire drug delivery vehicle. RISE’s formulation scientists develop emulsification, dispersion, coating, and encapsulation techniques to formulate sensitive substances in creams, gels, and micro- or nanoparticles.
  • 3D-Bioprinting – RISE is actively exploring 3D-printing of biomaterials, particularly for medical and life science applications. Our technology is used to combine living cells with biological or synthetic materials to build tissue-like structures. 

 

We further offer full characterization of the products in terms of mechanical performance, chemical safety, and accredited testing of biological function in vitro and in vivo. Please contact us for more information.

Markus Andersson Trojer

Forskare
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Aleksandra Kozlowski

Forskare
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Offer-pages:
Material selection and circular textile design
Bioeconomy Arena: test and scale up bio-based solutions with RISE
Division: Division Materials and Industry Biotechnology Sekundär områdes navigation:
Textiles
Medtech

Test methods for safe & sustainable healthcare products

Sustainability in healthcare products
Healthcare waste

The healthcare sector accounts for 4.4% of global greenhouse gas emissions. If it was a country, it would be among the five largest emitters. When there is a need to develop sustainable products and packaging for healthcare, RISE supports with expertise and tests that ensure both functionality and safety – from early prototype to finished solution.

Manufacturers of products for healthcare play a crucial role in ensuring that manufacturing and material choices are made with consideration for both chemical safety and sustainability from a life cycle perspective. 

Today, the healthcare sector worldwide produces large amounts of waste, averaging 2 kg per care place per day. By designing with a holistic approach from the start, manufacturers can reduce the amount of packaging material, simplify recycling, and support the transition from single-use to reusable products. When making changes in manufacturing processes, material choices, or recycling methods, it is important to carefully evaluate different options. The safety of both patients and healthcare staff must always be the primary consideration in all decisions. 

Our offer

To ensure that both functionality, safety, and environmental impact are considered from a life cycle perspective, we at RISE are inspired by the Safe and Sustainable by Design (SSbD) method. This method helps us evaluate several sustainability aspects of a product or process, from design to the end of the life cycle, where we strive to minimize negative effects and optimize both functionality and sustainability. 

We offer testing according to standards and can also tailor test packages specifically suited to your product, as well as adapted to the phase of product development you are in. 

For example, we can assist with the evaluation of:

Function

  • Absorption capacity: Tests according to EN 13726 and EN ISO 9073 for nonwoven products.
  • Abrasion resistance: Tests according EN ISO 12947.
  • Antimicrobial efficacy: Tests according to e.g. EN 17854, ISO 20743 or AATCC TM100.
  • Comfort: Tests for friction, thermal insulation, bending stiffness, draping, permeability, and Moisture Management.
  • Personal tests in climate chambers: Ability to record moisture and temperature at various locations in garments and products on or near the human body during activity or rest in climate rooms.
  • Aroma analysis: Tests according to SNV 195 651 (Panel odour test).
  • Aging: Accelerated aging in controlled chambers.
  • Cleanability: washing and drying of textiles and reprocessing of medical devices, including simulated use with test soil.
  • Tensile properties of textile materials: Tests according to ISO 13934-1 and -2.

Safety

Environmental impact

Sara Bogren

Avdelningschef
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Lene Jul Östblom

Enhetschef
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Offer-pages: Post-market support for medical devices Division: Division Materials and Industry Medtech Sekundär områdes navigation: Textiles

Development of bio-based, sustainable MedTech disposable product

A bio-based MedTech disposable product
Samples of cellulose

The project explored the potential to develop a bio-based disposable medical device with low environmental impact. It involved identifying more sustainable materials for products intended for short-term use inside the body.

Coordinator
Completed
Medical devices
Västra Götaland Region
1 year
1 MSEK
Division: Division Materials and Industry

This feasibility study successfully showed that the concept is highly promising. A bio-based disposable product can significantly reduce environmental impact. The project established a strong interdisciplinary network and emphasized the importance of life cycle assessments in material and supplier choices. Prototypes were developed, regulations mapped, and a foundation laid for future innovation.

Challenges remain, but the possibility of using bio-based materials for invasive medical devices is groundbreaking. At RISE, we have extensive expertise and testing resources across key areas to support the transition to bio-based materials in disposable products—including LCA, biocompatibility evaluation, regulatory knowledge, and recycling potential assessment.

Karin Agrenius

Enhetschef
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Henrik Bäckdahl

Forskare
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3. Good health and well-being
Project end date: Offer-pages: Post-market support for medical devices Medtech Sekundär områdes navigation:
Biobased materials
Circular transition
Biotechnology

Medical device packaging and products - Durability and properties

durability - medical devices
Tensile test to determine seal strength

Medical devices often have strict requirements, especially regarding shelf-life. At RISE, we offer comprehensive testing to ensure these requirements are met. Our tests are often based on standards such as ASTM F1980 and can include climate simulations and mechanical properties.

Customized Test Plans

Together with our customers, we tailor test plans that can include several different parts, both for the packaging and the product inside. A test plan can include:

  • Accelerated aging
  • Real-time aging
  • Climate resistance
  • Transport testing
  • Evaluation

We often include a validation step with preliminary studies to ensure a quality assured and predictable process.

Customer-Specific Testing Methods

To determine whether a product has aged, we often need to develop customer or product specific testing methods. As far as possible, we prefer to base these on established standards and methods, but they often need to be modified or combined in ways that are unique to the specific project or product.

 

Erik Lindhagen

Civilingenjör
+46 10 516 58 72 Read more about Erik

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Linda Eriksson

Laboratorieingenjör
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Division: Division Materials and Industry Medtech

Plasma treatment for improved biointegration of implants

CAIPIRENHA
Nanosized crystalline Hydroxyapatite coating

The world's population is increasing and with it comes the need for smart and safe medical implants. The project will further develop unique processes and equipment to contribute to faster and better healing.

Coordinator
Active
Production and manufacturing
Other than Sweden
2 år
828 k€
Division: Division Materials and Industry

The project will develop unique processes and equipment for implants based on atmospheric plasma.

The intention is to develop fine cleaning and activation processes based on atmospheric plasma. These will result in improved adhesion between the implant and nanohydroxyapatite coating, without degrading the materials. 

The processes are expected to replace wet chemical processes and result in improved durability and working environment, while achieving good cleaning and high process speed.

The S0741 - CAIPIRENHA project has received funding from the Swedish VINNOVA and the German Federal Ministry for Economic Affairs and Climate Action through Eureka and the Clusters programme and SMART Cluster. 

Åsa Lundevall

Forskare
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12. Responsible consumption and production
Promimic Fraunhofer IFAM Tigres GmbH Agaria (associerad partner)
Projekt logo: CAIPIRENHA Project end date: Medtech Sekundär områdes navigation:
Production and manufacturing
Composites

Imaging of biological surfaces and medical devices with SEM

Imaging of biomaterials with SEM
SEM image of cells on a scaffold

Do you have a medical device or a biomaterial, implant, or biological surface of any kind that you would like to image with high resolution? At RISE, we have access to scanning electron microscopy (SEM) with energy-dispersive X-ray spectroscopy (EDS) that can be used to evaluate the microscopic structure and chemical composition of the surface.

SEM image of fibroblasts cultured on a PEEK surface.

We offer multiple SEM-based services in the area of medical devices (e.g implants, surgical tools, dentistry equipment), where SEM and EDS can be used to evaluate microscale structure and composition of medical device surface as part of quality control or when troubleshooting production or functional failures. Further, SEM can be used to demonstrate functionality or mode of action of the device when imaging interfaces between medical devices and biological entities, such as cells, bacteria or tissues. Some specific examples of SEM applications in the field:

  • Cleanliness control (detect and identify surface contaminants and particles) when validating production or decontamination process of medical devices 
  • Pattern, pore-size or roughness evaluation of the device surface (stereo-SEM)
  • Determination of integrity, special distribution, chemical composition and thickness of the functional coatings
  • Particle size distribution in powders
  • Localization of bacteria and biofilms on for instance retrieved implants for improving their design
  • Visualization of biointerfaces between scaffolds/implants and cells/tissues 

The assignments are completely tailored to your requests, feel free to contact us with your inquiry!

Sarunas Petronis

Forskare
+46 70 375 58 66 Read more about Sarunas
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Division: Division Materials and Industry Medtech

ISO 10993-23 Skin Irritation - in vitro

Name of service (page headline, shown in promos – maximum of 70 characters incl. spaces): ISO 10993-23 Skin Irritation - in vitro Lead (include SEO-words and the main benefits for your target groups. Stick to one paragraph, maximum 2-3 sentences):

Irritation testing is a critical component of the biological evaluation of medical devices and a necessary step to meet the requirements of the Medical Device Regulation (MDR). RISE conducts irritation tests according to ISO 10993-23 and adheres to Good Laboratory Practice (GLP).

Purpose/Benefit:

Conducting irritation testing is crucial to ensuring that your medical device is safe for use. These tests help identify whether the product may cause irritation when it comes into contact with the skin.

By performing irritation testing, potential issues can be detected and addressed early in the development process, reducing the risk of adverse reactions for users. This is essential not only to protect patient health and safety but also to comply with regulatory requirements under the Medical Device Regulation (MDR) and international standards such as ISO 10993-23.

Furthermore, irritation testing helps build trust among users and healthcare professionals by demonstrating that your product has undergone rigorous safety evaluations. This not only prevents costly recalls and legal challenges but also ensures that your products are reliable and effective.

Method (what/which methods are used to perform the service):

Our skin irritation tests are based on a model consisting of human epidermal keratinocytes. These have been cultured to form a differentiated model of the human skin layer, which is comparable to the in vivo skin structure.

We perform skin irritation testing according to ISO 10993–23. The product extraction is conducted according to ISO 10993-12. We also conduct skin irritation tests according to OECD Test Guideline 439, where the skin model is directly exposed to a test chemical, without prior extraction.

We follow GLP

We adhere to Good Laboratory Practice (GLP), which ensures that the irritation tests are conducted in a scientifically valid and regulatory-compliant manner.

Delivery (what does the client get after performed service – e.g. a report, certificate etc.):

After completing the irritation test according to ISO 10993-23, you will receive a detailed test report in English. The report includes data showing the skin's reaction after exposure to the test material.

Area: Medical devices Contact person (Enter one name per field. Activated personal contact pages will appear automatically): Karin Nydahl, Laboratorieingenjör
MDR, medical,
Field measurements: No Price type: 1 Division: Division Materials and Industry Preparation: No preparation required Standards:

ISO 10993–23

ISO 10993-12

Certification and marking: Not applicable Type of service: Testing / Analysis / Evaluation Instrument: Not applicable General area: Not applicable Delivery level: Non-accredited
karin.nydahl@ri.se,
/en/node/9710
More information:

At RISE, we are pleased to offer testing services for medical devices according to both ISO 10993-5 and ISO 10993-23.

We also provide services to ensure that your products can be cleaned, disinfected, and sterilized safely and effectively according to ISO 17664-1/2 and ISO 17665.

By combining our services under these standards, we can help ensure that your medical devices are both biocompatible, sterile, and suitable for reuse—critical factors for patient safety and the product's success in the market.

Feel free to contact us for more information or to schedule a consultation.

3. Good health and well-being
Purpose - Header: Why conduct irritation tests? Metod - Header: Which methods do we use? Delivery - Header: Delivery
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Medtech Sekundär områdes navigation:
Metrology
Biotechnology
Tjänstetyp tagg: Provning

ISO 10993-5 Cytotoxicity Test - in vitro

Name of service (page headline, shown in promos – maximum of 70 characters incl. spaces): ISO 10993-5 Cytotoxicity Test - in vitro Lead (include SEO-words and the main benefits for your target groups. Stick to one paragraph, maximum 2-3 sentences):

Cytotoxicity testing is a crucial part of the biological evaluation of medical devices and is a necessary step to meet the requirements of the Medical Device Regulation (MDR). RISE conducts cytotoxicity testing according to ISO 10993-5 and is accredited under ISO/IEC 17025 or GLP (Good Laboratory Practice).

Purpose/Benefit:

By conducting cytotoxicity testing, you ensure that your medical device meets the necessary regulatory requirements under the Medical Device Regulation (MDR) and international standards such as ISO 10993-5.

The test is crucial for guaranteeing patient safety, ensuring that your product does not have harmful effects on cells when it comes into contact with the body. Additionally, cytotoxicity testing helps minimize risks by identifying and eliminating potentially harmful effects at the cellular level early in the product development process, protecting your company from costly recalls and legal issues.

Method (what/which methods are used to perform the service):

We conduct cytotoxicity testing according to ISO 10993–5 Annex C, the MTT test. This method is used to measure cell viability, i.e., the ability of cells to survive and function normally after exposure to extracts from a test material.

The MTT test is based on the principle that metabolically active cells can convert MTT, a yellow tetrazolium salt, into a blue-purple formazan crystal. The amount of formazan formed is proportional to the number of viable cells, providing a measure of the material’s cytotoxicity.

If the viability of the extract is reduced to <70% of the blank sample, the test is considered to have cytotoxic potential according to the standard.

We follow GLP

We are accredited under ISO/IEC 17025 and follow GLP (Good Laboratory Practice), ensuring that cytotoxicity tests are conducted in a scientifically valid and regulatory-compliant manner.

Delivery (what does the client get after performed service – e.g. a report, certificate etc.):

After completing the MTT test according to ISO 10993-5, you will receive a detailed test report in English. The report includes quantitative data showing cell viability after exposure to the test material.

Area: Medical devices Contact person (Enter one name per field. Activated personal contact pages will appear automatically): Karin Nydahl, Laboratorieingenjör
Ensure regulatory compliance with MDR and get support with biocompatibility testing/cytotoxicity testing according to ISO 10993-
Field measurements: No Price type: 1 Division: Division Bioeconomy Preparation: No preparation required Standards:

ISO 10993–5

ISO/IEC 17025

Certification and marking: Not applicable Type of service: Testing / Analysis / Evaluation Instrument: Not applicable General area: Not applicable Delivery level: Accredited
karin.nydahl@ri.se,
/en/about-rise/operations/mission-governance/policy-documents/privacy-policy
More information:

At RISE, we are pleased to offer testing services for medical devices according to both ISO 10993-5:2009 and ISO 10993-23.

We also provide services to ensure that your products can be cleaned, disinfected, and sterilized safely and effectively according to ISO 17664-1/2 and ISO 17665.

By combining our services under these standards, we can help ensure that your medical devices are biocompatible, sterile, and suitable for reuse—critical factors for patient safety and the product’s success in the market.

3. Good health and well-being
Purpose - Header: Why conduct cytotoxicity tests? Metod - Header: Which methods do we use? Delivery - Header: Delivery
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Medtech Sekundär områdes navigation:
Metrology
Chemical and biological analysis
Drug development
Tjänstetyp tagg: Provning

Microscopy analysis of biological surfaces

Microscopy imaging of biointerphases
Microscopy imaging

Do you have a material with antimicrobial effects that you wish to evaluate visually over time? Or do you want to evaluate the effect of a specific substance on, for example, cells or tissues? We have the capability to analyze surfaces with, for example, bacteria or cells and use staining of various markers to answer your specific question.

Fluorescence image of bacteria on surfaces stained with live/dead-staining, where green indicates living and red indicates dead bacteria. The image on the right has significantly fewer living bacteria, indicating antimicrobial properties on the surface.

At RISE, we have access to various bright field and fluorescence microscopes, allowing us to analyze different types of surfaces. By using different stains, specific parts of bacteria or cells can be detected and compared with various treatments. Examples of questions we can help you answer:

  • For antimicrobial materials, a live/dead staining can be used to estimate the antimicrobial effect of the substance on the surface.
  • We also have the capability to culture cells from various cell lines and evaluate growth with trypan blue staining, or by detecting different markers typical for, for example, migration and proliferation using various types of antibody staining with fluorescent markers.
  • We can also analyze sectioned tissue samples from in vivo experiments to detect different markers for, for example, inflammation or similar conditions.
  • We can also offer FISH analysis (Fluorescence in situ hybridization) and have expertise in karyotyping. FISH is a molecular cytogenetic analysis where specific genes are labeled with a fluorescent probe to detect, for example, loss, duplications, and translocations of chromosomal material.

The projects are tailored entirely to the customer’s needs and wishes. Feel free to contact us to learn more!

Example of stained cells in various stages of proliferation. Cell nuclei labeled with DAPI (blue) and actin (red), as well as vinculin (green).

Louise Wogelred

Forsknings- och utvecklingsingenjör
+46 10 516 52 42 Read more about Louise
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Division: Division Materials and Industry Medtech

EU reference laboratories for IVD class D devices

Name of service (page headline, shown in promos – maximum of 70 characters incl. spaces): EU reference laboratories Lead (include SEO-words and the main benefits for your target groups. Stick to one paragraph, maximum 2-3 sentences):

The European Commission has designated 5 different labs in Europe to become EU reference laboratories (EURLs) for high-risk in vitro diagnostic medical devices (IVDs) according to Article 100 of Regulation (EU) 2017/746.RISE has been designated in the scope "Respiratory viruses that cause life-threatening diseases" and " Blood grouping markers".

Purpose/Benefit:

The EURLs for high-risk in vitro diagnostic medical devices (IVDs) are designated according to Article 100 of Regulation (EU) 2017/746. This was done by the following implementing acts, Commission Implementing Regulation (EU) 2023/2713 and Commission Implementing Regulation (EU) 2025/2526 designating EU reference laboratories in the field of in vitro diagnostic medical devices.

The main tasks of the EURLs: advisory ones and those related to conformity assessment, particularly of the highest risk, i.e., class D devices. The EURLs were chosen on the criteria within and will work with the tasks listed in Commission Implementing Regulation (EU) 2022/944.

For conformity assessment of class D devices, the EURLs will:

  • verify the performance of class D devices and compliance with common specifications,
  • perform batch testing of class D devices. 

The designated laboratories are:  

1. RISE Research Institutes of Sweden, Sweden

2. Consulting Químico Sanitario SLU, Spain 

3. Instituto de Salud Carlos III, Spain

4. EU Referenzlabor für In-vitro-Diagnostika am Paul-Ehrlich-Institut, Germany

5. Consortium, Servicio Madrileño de Salud (SERMAS), consisting of 3 hospitals: 

a. Hospital General Universitario Gregorio Marañón, Spain 

b. Hospital Universitario la Paz, Spain 

c. Hospital Universitario Ramón y Cajal, Spain 

Method (what/which methods are used to perform the service):

For new products, a performance test will be carried out, for products already tested, there will be a batch test. 

All communication from manufacturers is through Notified Body.

Delivery (what does the client get after performed service – e.g. a report, certificate etc.):

The EU reference laboratories are working with Notified Bodies and delivering to them. 

Delivery time:

The order is placed through the Notified Body.

Area: Life Science Contact person (Enter one name per field. Activated personal contact pages will appear automatically):
Benny Lyvén, Affärsutvecklare
Hardis Rabe, Forskare
RISE EU reference laboratory espiratory viruses that cause life-threatening diseases
Field measurements: No Price type: 1 Division: Division Materials and Industry Preparation: No preparation required Standards:

ISO17025

Certification and marking: Not applicable Type of service: Testing / Analysis / Evaluation

What scopes of the class D devices are covered by the EURLs?

- Hepatitis and retroviruses
- Herpesviruses
- Bacterial agents
- Respiratory viruses that cause life-threatening diseases
- Parasites
- Blood grouping markers

Which scope are covered by which EURL?

Can be found in the Implementing act: https://eur-lex.europa.eu/eli/reg_impl/2023/2713/oj and https://eur-lex.europa.eu/eli/reg_impl/2025/2526/oj

Status of EU reference laboratories

The designation act includes transitional arrangements to allow the EURLs to form a network and harmonize their working methods and for manufacturers and notified bodies to adapt their processes to include EURL testing.

The EURLs have started their tasks in the conformity assessment of devices since1 October 2024.

EURLs have created a network to coordinate and harmonize their working methods. They are all both working as a whole network with all laboratories as well as scope specific networks. The general network and the sub-networks works on harmonization of methods, procedures, processes, etc. in particular on common laboratory test procedures for performance verification and batch testing of devices. The works also will also adopt common rules of procedure. RISE is coordinating this work.

What will the fee be for using the EURLs?

The fees that the EURLs are going to use are according to Commission Implementing Regulation (EU) 2022/945

Rules for Setting the Fees for EU Reference Laboratories (EURL)

Fee Coverage

Fees levied by EU Reference Laboratories may cover the following categories of costs:

1. Staff costs: Includes staff hours, travel, accommodation, and subsistence costs.
2. Equipment costs: Applicable when the equipment is not provided by the manufacturer of the device to be tested.
3. Consumables, test specimens, and reference materials.
4. Shipping costs: For sample transportation.
5. Translation costs.
6. General laboratory operation costs.

Outsourced Testing
When a task is outsourced to another laboratory under a contract, the fees may include the costs paid to that laboratory for completing the requested task.

Fee Calculation Principles
1. Fees must be non-discriminatory, fair, reasonable, andproportionate to the services provided.
2. Fees shall be calculated based on incurred costs.
3. If calculating the incurred costs for a particular category (staff, equipment, consumables, shipping, translation) is unreasonably burdensome, the EURL may estimate the costs based on average costs for that category.
4. The fee for general operation costsshall be determined as a percentage of the combined costs of the other categories and may not exceed 7% of those costs.

How do notified bodies work with EURLs?

We are currently working together with the NBGC Med-IVD Class D on how the EURLs and NB will be working together.
The EURLs will have contact with the Notified bodies for testing of devices and not with the manufacturers.

How do notified bodies work without EURLs?

For class D devices must be tested by the EU reference laboratory before they may be placed on the market, regardless of whether or not they are novel. There are two key types of testing – verification of performance and batch testing.

Regarding the conformity assessment of devices without a designated EURL, they may still be certified by notified bodies and placed on the EU market according to Regulation (EU) 2017/746.

The EURL-related elements of the conformity assessment do not apply to them until an EURL is designated. Please see MDCG 2021-4 for guidance on how the EURLs should be integrated into the conformity assessment process when designated.

What if there is no EURL for an class D testing scope yet?

For the remaining 2 categories, namely arboviruses and haemorrhagic fever and other biosafety level 4 viruses, there were either no laboratories that satisfied the criteria or their combined capacity was insufficient to cover the expected volume of requests. There has been a call for interest out for the remaining scopes, which is now processed by EC. Expression of interest open – Possible second call for EU reference laboratories for high-risk in vitro diagnostic medical devices - European Commission (europa.eu)

Recommendations on suitable reference materials and reference measurement procedures of higher metrological order

According to IVD regulation 2017/746, Article 100 (2h), EURLs have to provide recommendations on (i) suitable reference materials and (ii) reference measurement procedures of higher metrological order for their specific scopes. This applies only to devices whose intended use is related to class D. The purpose of sharing this information is that class D IVD stakeholders have availability of references regarding standards and metrological traceability of IVD devices.

Information on (i) suitable reference materials:

EURL Scope 5, respiratory virus
Pathogen: MERS-CoV
Marker: MERS-CoV Antibody
Reference material: 1st International Standard for anti-MERS-CoV immunoglobulin G (human)
Reference and provider: 19/178, NIBSC

Pathogen: MERS-CoV
Marker: MERS-CoV Antigen
Reference material: Not available
Reference and provider: Not available

Pathogen: MERS-CoV
Marker: MERS-CoV RNA
Reference material: Not available
Reference and provider: Not available

Pathogen: Highly virulent Influenza virus (HVI)
Marker: Antibody HVI
Reference material: Not available
Reference and provider: Not available

Pathogen: Highly virulent Influenza virus (HVI)
Marker: Antigen HVI
Reference material: Not available
Reference and provider: Not available

Pathogen: Highly virulent Influenza virus (HVI)
Marker: RNA HVI
Reference material: Not available
Reference and provider: Not available

In relation to reference measurement procedures of higher metrological order (ii),
some database can be consulted. The JCTLM Database lists higher-order
reference materials, measurement methods and services to be used in calibration
hierarchies for value assigning calibrators and trueness control materials for
quantities measured by in vitro diagnostic medical devices. The listed reference
materials, measurement methods and services when applied following the models
described in ISO 17511:2020, ‘In vitro diagnostic medical devices —Requirements
for establishing metrological traceability of values assigned to calibrators, trueness
control materials and human samples’, can be used to establish metrological
traceability.

Besides JCTLM, other publications in relation to metrological traceability have
been also selected as possible source of recommended procedures of higher
metrological order and general framework for this topic:
• CLSI EP32 - Metrological Traceability and Its Implementation
• ILAC P10:07/2020 ILAC Policy on Metrological Traceability of Measurement
Results
• Establishing metrological traceability in laboratory medicine
• European Metrology Network (EMN) for Traceability in Laboratory Medicine
(TraceLab Med)
• MDCG 2020-16 rev.4 Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746.

Shipment instructions RISE-EURL-IVD

Please note that 100% of the cost for delivery/transport have to be paid by the manufacturer.

The kits should be sent to the following address:
RISE Research Institutes of Sweden AB
Att: EURL, Name
Brinellgatan 4, House 6 gate G
504 62 Borås
Sweden

EORI Nr. SE5564646874
VAT nr: SE556464687401

Companies that are not part of the European Union must create a Pro Forma invoice in order for the shipment to be cleared through customs to Sweden accompanied by a delivery note.

The Pro Forma invoice must contain the following information.
• The purpose of the export. (Use any of the following, “Sample for testing purposes according to IVD regulation” / “for in vitro use only” / “for testing purposes only” / “not for human use”)
• Contents/identity of the shipment. (Kit name, lot no.)
• Parcel type.
• Gross weight.
• Taric/HS code of the contents.
• The value of the contents followed by the text “No charge. Value for customs purposes only.”
• Country of Origin
• Delivery terms, Incoterms 2020 DDP Borås, Sweden.

The delivery note must contain (for both non-European companies and European companies):
• Product name and model.
• Number of items.
• Special information about the product. (The kits should be stored at the recommended storage temperature (e.g., 2-8°C).) This to avoid that the kits will be stored at too warm temperature in case there is any delay with the customs declaration. This special information must also be clearly and visibly written outside on the box.

Use express delivery or equal and make sure that the delivery will be made door-to-door to avoid unnecessary stops at airports or other storage terminals.

When the shipment is ready to be shipped, please contact us by e-mail and inform about the details including date, flight number or reference (track) number.

Collaborations with national reference laboratories (NRLs)

According to IVD regulation 2017/746, Article 100 (2h), and 2022/944 (art 15) EURLs have to set up and manage a network of national reference laboratories (NRLs) after consulting with the national authorities and publish a list of the participating NRLs and their respective tasks. The purpose of this interaction is among others to favor collaborations, sharing know-how and testing methods.
For corresponding scopes, the NRLs that have been identified and with which there has been interaction for possible collaborations are:
- Scope 5 (respiratory virus): Erasmus MC (Netherland), Hospices Civils de Lyon (France) and Folkehelseinstituttet (FHI) (Norway)

The tasks with these NRLs are planned to be (i) networking and (ii) harmonization of methods

Instrument: Not applicable General area: Not applicable Delivery level: Accredited
benny.lyven@ri.se,hardis.rabe@ri.se
/en/node/9710
More information:

Funded by the European Union. Views and opinions expressed are however those of the author(s) only and do not necessarily reflect those of the European Union or HaDEA. Neither the European Union nor the granting authority can be held responsible for them.

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