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EU IVDR & MDR regulations

Copan is ready!

The new Medical Devices Regulation (EU) 2017/745 (MDR) and the In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR) will create a robust, transparent, and sustainable international regulatory framework to improve the safety of medical devices. The new regulations impact all the stakeholders of the healthcare environment, from the manufacturing industries to doctors, practitioners, and laboratorists that must comply with MDR/IVDR in their daily activities.

All the CE-marked MDs and IVDs will be affected by the new MD and IVD Regulations.

At Copan, we are committed to ensuring our products’ conformity with the EU Regulations to provide the best service to our customers. We have worked relentlessly in the last years to comply with applicable MDR and IVDR requirements. As a result, our product regulatory compliance and supply reliability are guaranteed, ensuring our trusted partners and clients any product family disruption throughout this transition period.

EU IVDR

We completed the transition from IVDD general devices to IVDR CLASS A devices within the date of IVDR application of May 26, 2022, while the certification process for our CLASS A STERILE devices is at an advanced stage and these devices will be gradually CE-marked according to EU IVDR before the new deadline of 31 December 2029.

 

EU MDR

We implemented quality procedures to comply with the EU MDR requirements (e.g., Vigilance and Post-Market Surveillance requirements) that are in force from the MDR application. The certification process for our CLASS IIa devices is at an advanced stage. Our MD CLASS IIa devices will be gradually CE-marked according to EU MDR and we’ll be able to communicate the CE mark transition to MDR three months before the expected date.

Togetherness

Together towards new regulations

Our Regulatory and Quality departments are committed to giving you the best support in this transition. Do not hesitate to contact us for any need.

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Microbiology Time – June 2022

Microbiology time

Our scientific database has been updated with the most recent studies that take advantage of our products. This month’s top picks span from HPV self-collection to measles and antibiotic-resistant bacteria:

  • Alice Avian and colleagues assessed whether HPV Selfy, a full-genotyping HPV DNA test, meets the international criteria for primary cervical cancer screening on clinician-collected and self-collected samples. HPV Selfy sensitivity and specificity resulted similar to the reference testing method, reaching adequate reproducibility. Moreover, this study demonstrated that the performance of HPV Selfy on self-collected vaginal samples was non-inferior to the performance obtained on clinician-collected cervical specimens.
  • In the second study, published on Viruses, an Italian team of scientists investigated cases of measles breakthrough during surveillance activities in Milan and surrounding areas between 2017 and 2021. The researchers spotted measles virus infections in some of the vaccinated individuals tested, suggesting a vaccination failure – probably due to the poor immune response of single individuals – and highlighting the importance of identifying breakthrough cases and characterizing their clinical and virologic profiles.
  • Annaleise R. Howard-Jones’ team describes in the third study an outbreak of carbapenemase-producing Enterobacterales in a COVID-19 intensive care unit, discussing workable and efficient infection control measures. By isolating specimens from patients and the environment and performing whole genome sequencing analysis, the researchers identified a few isolates of carbapenemase-producing Klebsiella pneumoniae. Infection control interventions – including careful adherence to contact precautions and hand hygiene, screening for multidrug-resistant organisms, strict antimicrobial stewardship, and enhanced cleaning protocols – promptly terminated the outbreak.

Discover the complete studies below, and see you in July!

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Microbiology Time – June 2022

News

Our scientific database has been updated with the most recent studies that take advantage of our products. This month’s top picks span from HPV self-collection to measles and antibiotic-resistant bacteria:

  • Alice Avian and colleagues assessed whether HPV Selfy, a full-genotyping HPV DNA test, meets the international criteria for primary cervical cancer screening on clinician-collected and self-collected samples. HPV Selfy sensitivity and specificity resulted similar to the reference testing method, reaching adequate reproducibility. Moreover, this study demonstrated that the performance of HPV Selfy on self-collected vaginal samples was non-inferior to the performance obtained on clinician-collected cervical specimens.
  • In the second study, published on Viruses, an Italian team of scientists investigated cases of measles breakthrough during surveillance activities in Milan and surrounding areas between 2017 and 2021. The researchers spotted measles virus infections in some of the vaccinated individuals tested, suggesting a vaccination failure – probably due to the poor immune response of single individuals – and highlighting the importance of identifying breakthrough cases and characterizing their clinical and virologic profiles.
  • Annaleise R. Howard-Jones’ team describes in the third study an outbreak of carbapenemase-producing Enterobacterales in a COVID-19 intensive care unit, discussing workable and efficient infection control measures. By isolating specimens from patients and the environment and performing whole genome sequencing analysis, the researchers identified a few isolates of carbapenemase-producing Klebsiella pneumoniae. Infection control interventions – including careful adherence to contact precautions and hand hygiene, screening for multidrug-resistant organisms, strict antimicrobial stewardship, and enhanced cleaning protocols – promptly terminated the outbreak.

Discover the complete studies below, and see you in July!

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Microbiology Time – June 2022

It was a pleasure to meet you there

The first in-person ECCMID of the last three years has been an event dense with meetings and science: thanks to all the people who visited our booth!
We hope you had a great time speaking with Copan’s people and got enthralled by our ingenious sample collection solutions and cutting edge-lab automation: in other words, our WISE approach!

Be WISE!

Four decades of innovation and collaboration with healthcare professionals allowed us to conceive a complete ecosystem that seamlessly integrates into any workflow, taking care of biological samples from their collection to the latest diagnostic platforms. That’s not big news, but today our comprehensive approach finally got a name:
WISE – Workflow-Integrated System Environment

Copan Group
Copan Group
Copan Group

Copan sponsored Integrated Lunch Symposia

Sample self-collection, a lesson gained during the COVID pandemic

During Copan’s ECCMID integrated symposium, four distinguished speakers updated the audience on the advances, achievements, and future trends of sample self-collection in different fields (STIs, HPV, respiratory infections, genetics, serology).

To the symposium page
Copan

Copan Winter Tour 2022

Make your lab WISE!

Last winter, we traveled across Europe to visit four microbiology labs and gather first-hand experiences and future perspectives on lab automation.
Listen here to our interviews with microbiology experts, clinicians, and lab technicians to understand how switching to a WISE lab revolutionized their daily activities!

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Sample self-collection, a lesson gained during the COVID pandemic

During the symposium, four distinguished speaker updated the audience on the advances, achievements, and future trends of sample self-collection.
The talks explore self-collection experiences in different fields
(STIs, HPV, respiratory infections, genetics, serology) and will dig all the challenges and opportunities of this specimen collection approach that improves patient comfort and confidence, reduces health care provider hands-on time and risk of exposure to infections, supporting sample management for the pre-analytics.
If you attended ECCMID, you can watch the full symposium on the congress platform. If not, watch the talks below!

To the ECCMID platform

Prof. Johan Melendez – Johns Hopkins School of Medicine – Baltimore (US)

Social innovation to increase access to STI testing during COVID-19: The IWantTheKit Program

Watch the video
Copan

Prof. Clementina Elvezia Cocuzza – University of Milano-Bicocca – Milan (Italy)

Cervical cancer prevention during the COVID-19 pandemic: home self-collection for the safe participation of women in screening

Watch the video
Copan

Dr. Geoffrey Behrens – DKMS Life Science Lab GmbH – Dresden – (Germany)

High throughput HLA typing and CMV antibody detection from self-collected buccal swabs

Watch the video
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Prof. Elisa Borghi – Università Statale di Milano – Milan (Italy)

Self-collection as a tool for active surveillance of asymptomatic SARS-CoV-2 infection

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Copan

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