Apr 8, 2020

European Union member states face similar crises as the US and other countries regarding shortages of medical devices and equipment needed to treat COVID-19 patients, driving the need for emergency access to European healthcare markets for these products at a faster rate than for the standard conformity assessment routes to obtain a CE Marking certification.

Similar to our post on US FDA Emergency Use Authorizations for medical devices and IVDs in short supply, we’ll examine processes available to EU member states whereby governments may temporarily authorize market access for needed devices and supplies.

Expedited EU Conformity Assessment procedures

In order to improve EU access to personal protective equipment (PPE), surgical masks and similar equipment as well as ventilators, respiratory equipment and IVD test kits to detect coronavirus infections, the European Commission has recommended to allow derogations from conformity assessment procedures, authorized by member states, on justified requests for the placing on the market and putting into service, within the territory of the member state concerned, of individual devices for the protection of healthcare providers tackling the COVID-19 crisis.

Under normal circumstances, obtaining a CE Marking certificate in Europe for a medical device, IVD or PPE involves a conformity assessment either from a Notified Body or a self-declaration for low-risk products and low categorized products, as stipulated under the European Medical Devices Directive (93/42/EEC, or MDD), Active Implantable Medical Devices Directive (90/385/EEC, or AIMDD); the In Vitro Diagnostic Medical Devices Directive (98/79/EEC, or IVDD) for IVD devices; and Regulation (EU) 2016/425 for PPE. Notified Body conformity assessments of these devices and PPE products can range from several months for some PPEs to roughly a year or longer for high-risk medical devices and IVDs.

However, in emergency public health situations both the European Commission as well as EU member states individually have the ability to temporarily permit access to EU markets for devices and PPE products that have not gone through or have not yet  completed the required conformity assessment based on the applicable legislation, and thus have not yet received the CE Marking certificate or are not yet able to affix the CE mark to the device (for self-declared products).

Member State-level authorizations required

Specific requirements for marketing eligible medical devices, AIMDs, IVDs and PPE products via emergency pathways are imposed singly by European member states. Individual Competent Authorities thus grant permissions for emergency market access in their respective countries, so manufacturers should take into account variance in terms of processes and requirements from one EU member state to another if pursuing emergency access.

Emergency EU market access specific to COVID-19

The European Commission has identified devices and PPEs that will be temporarily allowed for sale without CE Marking in response to the COVID-19 crisis.

  • PPE: The EC has temporarily allowed the marketing of non-CE marked PPEs (gloves, face masks, etc.) in the following scenarios:
  1. If a national Competent Authority (CA) finds that the PPE s in the EU market ensure an adequate level of health and safety in accordance with the Essential Requirements set out in EU law, the CA may authorize access for these PPEs to the EU market, even though the conformity assessment procedures, including the affixing of CE marking, have not been fully finalized.
  2. In exceptional circumstances, where certification procedures have not been initiated and no CE Marking has been affixed, if the following cumulative conditions are fulfilled:
  1. the PPEs are manufactured in accordance with one of the EN standards or other standards referred to in World Health Organization (WHO) guidelines or a technical solution ensuring an adequate level of safety;
  2. b) the PPEs are part of a purchase organized by the relevant member state authorities;
  3. the PPEs are only made available for healthcare workers;
  4. the PPEs are only made available for the duration of the current health crisis; and
  5. the PPEs are not entering the regular distribution channels and made available to their users.
  • Medical devices and IVDs: Devices without CE Marking will only be allowed temporary European market access in cases where no alternative products or treatments are available pertaining to the COVID-19 pandemic, and a request has been made to the EU member state where the devices are placed on the market. Member states will assess requests on a case-by-case basis.  Requests can be made by all Economic Operators.
  • Biocides: Some member states have also announces to temporary allow certain disinfectant gels and other biocides on the market in case they are  to be used by healthcare providers treating patients infected with coronavirus in Europe.

Conformity assessments of qualifying PPE devices and equipment granted emergency EU market access entails the following components:

  • Notified Bodies certifying PPE under Regulation (EU) 2016/425 should prioritize 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 Regulation (EU) 2016/425 health and safety requirements;
  • Notified Bodies certifying PPE manufactured following non-harmonized standards should notify other Regulation (EU) 2016/425 Notified Bodies as well as relevant Competent Authorities of these certifications;
  • For medical devices, derogations from standard conformity assessment in order to facilitate emergency market access should be considered based on Article 11(3) of the MDD as well as Article 59 of Regulation (EU) 2016/425 for PPEs if applicable.

Please note that the European Standardization Institute CEN/CENELEC have made standards relevant to products such as gloves and face masks needed to combat COVID-19 freely available.

Specific products currently slated for emergency European market access include face masks for protection against particulates as well as gowns, gloves and eyewear for protection against biological agents (these products fall under Regulation (EU) 2016/425 for PPE), as well as surgical masks, examination gloves and gowns, which all fall under both the MDD and Regulation (EU) 2016/425. Guidance on these temporary measurements can be found here.

 

Learn how other device markets are responding to COVID-19.

 

Market surveillance obligations

As with conformity assessments, European regulators are also making allowances for post-market surveillance requirements for devices and products granted emergency market access—but not without conditions.

While Competent Authorities should prioritize focus on medical devices, IVDs and PPEs that pose serious risks to intended users and patients, they may authorize use for a limited time of products targeting COVID-19 that do meet health and safety requirements even if those products have yet to complete conformity assessment and CE Mark affixation. (Conformity assessment processes should nonetheless still be carried out while these devices and products are made temporarily available to European markets.)

Furthermore, non-CE Marked PPE, medical devices and IVDs may be procured by EU member states to address COVID-19 outbreaks provided that those products are available to healthcare providers only until the public health crisis ends; the European Commission also forbids member state authorities from allowing distribution of these devices and products via regular channels.

Finally, market surveillance authorities should notify the European Commission as well as other EU member states of any and all temporary access permissions they issue for specific PPE, medical devices or IVDs. Authorities should utilize the Information and Communication System for Market Surveillance (ICSMS) to report specifically on temporary market access for PPE in these instances.

Given rapid developments regarding the COVID-19 emergency in Europe, Emergo by UL consultants will provide additional information on emergency market access for PPE, medical devices and IVDs as new details emerge.

Learn more about European regulatory responses to the COVID-19 pandemic:

  • COVID-19 regulatory news and analysis resource center
  • European Medical Devices Regulation (MDR) preparation and resource center
  • European CE Marking consulting for IVD manufacturers
  • European CE Marking strategy for medical device  companies

Author

  • Annette van Raamsdonk and Stewart Eisenhart

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