COVID-19 Pandemic: Emergency market access for PPE, medical device and IVD manufacturers- Made easier and cost effective by Ascent EMIRATES Group.
The global coronavirus Covid-19 pandemic requires a global response. The Covid-19 / SARS-2 Virus / Cornonavirus-2 has created a mass pandemic across countries and regions, without any exclusions. The world quickly needs to respond, develop and deploy active diagnostics, treatments and a vaccine. Without these, countries might remain vulnerable.
Countries and organisations like Ascent EMIRATES around the world are joining forces to ensure that not only do we develop these life-saving tools but that we ensure they are quality-assured, available and affordable.
Human suffering and the devastating social and economic consequences of COVID-19, we at Ascent EMIRATES Group have launched a landmark, easy, global collaboration with various Associates, Certification Bodies, Testing Labs and Notified Bodies for the accelerated testing and certification of various products and systems needed urgently to fight Covid-19 / SARS-2 Virus / Cornonavirus-2 including assurance about essential health technologies.
Expedited Conformity Assessment procedures for CE Marking Certification
In order to improve admittance to personal protective equipment (PPE), surgical masks and similar equipment as well as ventilators, respiratory equipment and IVD test kits to fight and prevent coronavirus infections (or aggravation of the infections), we at Ascent EMIRATES on advisories, and regulations from the European Commission has recommended to allow exceptions / relaxations from conformity assessment procedures, authorized, on justified requests for the placing on the global market and putting into service, of individual devices for the protection of general public and including healthcare providers tackling the COVID-19 crisis.
Under normal circumstances, obtaining a CE Marking certificate for a medical device, IVD or PPE involves a conformity assessment either from a Notified Body or Certification Body (self-declaration for low-risk products and low categorized products), based on Categories / Classifications of Products as stipulated under the following:
- Machinery Directive (2006/42/EC)
- Medical Devices Directive (93/42/EEC, or MDD)
- Active Implantable Medical Devices Directive (90/385/EEC, or AIMDD)
- In Vitro Diagnostic Medical Devices Directive (98/79/EEC, or IVDD) for IVD devices
- Regulation (EU) 2016/425 for PPE.
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Where required and essential, Notified Body conformity assessments of these devices and PPE products generally ranges from several months for some PPEs to roughly a year or longer for high-risk medical devices and IVDs.
But because of this emergency public health situations all the Authorities / Regulatory Bodies have come out with Regulations on the ability to temporarily permit access to EU markets for devices and PPE products based on the applicable legislation, so that the procedures are made less bureaucratic and less complex, and so that the timelines are lessened greatly and so that things get along urgently in a cost-effective manner.
Conformity assessments of qualifying PPE devices and equipments have been granted emergency EU/GCC market access and this entails the following:
- Certification Bodies, Notified Bodies and Testing Labs certifying PPE under Regulation (EU) should arrange on priority basis conformity assessments of newly submitted products deemed necessary for protection against COVID-19;
- PPE manufactured under methods other than harmonized standards may be allowed emergency access based on World Health Organization (WHO) recommendations for appropriate PPE selection; manufacturing methods should nonetheless ensure proper levels of protection aligned with PPE Regulation (EU) health and safety requirements;
- Certification Bodies, Notified Bodies and Testing Labs certifying PPE manufactured following non-harmonized standards should contain a notification of these certifications;
- For medical devices, exceptions / relaxations from standard conformity assessment in order to facilitate emergency market access has to be considered based on certain regulatory requirements for PPEs if applicable.
Ascent EMIRATES Group has geared up to develop suitable processes to conduct the following through Approved Testing Labs and Notified Bodies:
- Marking & Certification
Specific products currently slated for emergency Covid-19 situation include the following:
- Protective Face Masks (Respiratory Protective Devices)
- Medical Face Masks
- Face Shield / Visors
- Personal Eye Protection
- Protective Clothing
- Protective Clothing against liquid chemicals
- Medical Clothing, drapes, gowns and clean air suits
- Medical Gloves
- Protective Gloves
- Medical Equipment eg. Ventilators, Hospital Equipment
- Hospital furniture
- Disinfecting Booths
We at Ascent EMIRATES also have developed procedures for the following:
- Guidance on Preparing Workplaces for COVID-19
- Worker Exposure Risk to COVID-19
- Guidance for specific industries:
- Construction (after Lockdown, as per the specific Country’s Government Regulations)
- Manufacturing (after Lockdown, as per the specific Country’s Government Regulations)
- Malls (after Lockdown, as per the specific Country’s Government Regulations)
- Cinema Halls (after Lockdown, as per the specific Country’s Government Regulations)
- Public Gatherings (after Lockdown, as per the specific Country’s Government Regulations)
- Religious Gatherings (after Lockdown, as per the specific Country’s Government Regulations)
- Other Industry Types (after Lockdown, as per the specific Country’s Government Regulations)
- Occupational Health & Safety Guidelines and Procedures