Medical Device and IVD Emergency Use Routes in Europe

The EU regulatory framework is based on Directive 93/42/EEC—the “Medical Devices Directive” (MDD). Active implantable devices are separately controlled under Directive 90/385/EEC (AIMD). And In Vitro Diagnostics are controlled under Directive 98/79/EC (IVDD). The medical devices directives are transposed into each EU member state’s legislative statutes. In May 2017, the Medical Devices Regulation (MDR) (EU) No. 2017/745 and In Vitro Diagnostic Medical Devices Regulation (IVDR) (EU) 2017/746 were formally published in the Official Journal of the European Union (OJEU) and will be phased in over the coming years.

Personal protective equipment (PPE) regulation is also harmonized in the EU. PPEs are regulated under Regulation (EU) 2016/425 (the PPE regulation), which covers the design, manufacture, and marketing of personal protective equipment.

Overview of standard regulatory requirements in Europe

The standard process for medical devices, IVDs, and PPEs includes a Conformity Assessment. Depending on the risk class of the medical devices or IVDs, or category of the PPE, devices are either self-declared or need a Notified Body to review the documentation and issue a CE certificate. Notified Body involvement is required for all medical devices except Class I self-declared devices (non-sterile, non-measuring, and under the MDR Class I non-reusable surgical instruments), all IVDS listed in List A or B of Annex II IVDD and/or IVDs for self-testing, and all PPEs classified in Category II or III. The Notified Body review generally ranges from several months (PPEs) to almost a year (certain high-risk medical devices and IVDs) to complete.

In the case of urgency relating to health and safety, the European Commission (EC) and member states can grant access to the EU market for devices that have not followed the normal conformity assessment routes. All aforementioned EU regulations include a derogation article, by which member states are able to temporarily authorize a device. The EC can extend for a limited period of time the validity of the aforementioned authorization granted within the territory of the EU, and can set conditions under which the device may be placed on the market or put into service.

For such acts, there needs to be duly justified imperative grounds of urgency relating to the health and safety of humans. Decisions on granting access to the EU market for devices which have not followed the conformity assessment routes will always be made public by the EC. In patient-specific cases, the manufacturer needs to make a request to the member state.

COVID-19 specific exceptions

A general overview can be found in the EC Commission document, How to verify that medical devices and personal protective equipment can be lawfully placed on the EU market and thus purchased and used – also in the COVID-19 context.

Personal Protective Equipment (PPE)

In response to the COVID-19 outbreak, the EC has temporarily allowed the marketing of non-CE marked personal respiratory protective equipment (and other personal protective equipment) through Commission Recommendation (EU) 2020/403. The marketing of these devices is permitted if a number of criteria are met. This only applies to equipment intended to protect healthcare professionals from the coronavirus SARS-CoV-2).

Medical Devices and IVDs

Member states may temporarily allow healthcare providers to use non-CE marked medical devices for which no alternatives are available at this moment due to the COVID-19 pandemic. Notably, some member states have adopted additional measurements regarding export of the aforementioned devices.

The EC has issued a new draft document, Current performance of COVID-19 test methods and devices and proposed performance criteria. As COVID-19 IVDs are self-certified according to the IVDD, it is highly recommended that manufacturers who want to place these IVDs on the EU market review and apply this guidance document. The document emphasizes the importance of understanding first what information different tests can deliver (i.e., what is the intended purpose of a given test), and second, the level of a test’s performance (i.e., how well it is able to achieve that purpose). Therefore, manufacturers need to regularly monitor their data and compare it to the evolving state of the art. The document includes considerations on device performance and validating that performance.

Biocides

Some biocides, such as disinfection gels, are temporarily allowed to be used by healthcare professionals, to disinfect the hands against the coronavirus, without having followed the conformity assessment route for these devices. More information specific to the Netherlands can be found on the CTGB website. The EC has published guidance for hand gel manufacturers.

Stay informed about special access routes in response to COVID-19

Emergo by UL consultants are monitoring the development of expedited regulatory routes in medical device markets worldwide. The situation is changing daily, and we encourage you to create a free RAMS account, where you can access real-time updates on COVID-19 regulatory developments from our international research team.

 

Get free EU regulatory updates on COVID-19

 

Regulations, guidance, and resources

Derogation provisions and specific COVID-19 information can be found here:

Standards to show conformity for certain devices are now made publicly available:

Stockpiling information:


Device types and eligibility criteria

Devices that are currently eligible for the emergency route are:

  • Face masks ensuring protection against particulate hazards, gowns, gloves, and eyewear protection, which are used for prevention and protection against biological agents (Regulation (EU) 2016/425). 
  • Surgical masks, examination gloves, and some types of gowns fall within the scope of Directive 93/42/EEC and of Regulation (EU) 2017/745.

Category III PPE devices have Notified Body involvement. Currently manufacturers use harmonized standards to show compliance. In the current emergency situation, Notified Bodies are allowed to conclude that a PPE following another specific standard or technical solution is compliant with the essential health and safety requirements applicable to it. The following mouth masks do not need additional review:

  • Masks from China: the masks KN95, KP95 and KN100, KP100 respectively, which have been tested against the Chinese GB 2626-2006 standard (followed by the GB 2626-2019 standard);
  • Masks from the United States: the mouth masks N95, P95, R95 and N100, P100, R100, P99, R99, respectively, which have been tested against the American NIOSH 42 CFR 84 standard.

Refer to the EC letter here, listing the eligible devices.

In general member states throughout the EU are cooperating, after the EC decided to create a strategic stockpile (“rescEU stockpile”) of medical equipment such as ventilators and protective masks to help EU member states deal with the COVID-19 pandemic. More information on the rescEU stockpile can be found on the European Commission website.

The stockpile will include items such as:

  • Intensive care medical equipment such as ventilators
  • Personal protective equipment such as reusable masks
  • Vaccines and therapeutics
  • Laboratory supplies

Pathway overview

The specific requirements for the import and sale of eligible devices under the emergency route is set at a member-state level, rather than at the EU level. In general, it will be necessary to obtain permission from the Competent Authority; however, the process and requirements will vary from state to state.

A list of Competent Authorities and contact information may be found on the EC website.


Notified Body accreditation/competency

While measures outlined above have been undertaken by the EU Commission to facilitate the supply of essential PPE during the COVID-19 pandemic, evidence of CE compliance may still be leveraged in other jurisdictions where manufacturers wish to pursue traditional registration routes outside of local emergency pathways adopted.

As such, it is important to verify that such evidence, when applicable, is issued by a Notified Body with the appropriate accreditation/competency. The New Approach Notified and Designated Organisations (NANDO) Information System can be consulted to verify Notified Body accreditation/competency.

Simply locate the name of the Notified Body indicated on the certificate presented and verify whether the legislation described on the certificate is listed under the ‘Legislations’ covered under the Notified Body’s accreditation. It may also be necessary to view the specific details of accreditation under a specific legislation to verify that certain types of products are within the scope of accreditation.

Notified Bodies and the legislation they are designated to can be found here:

Please note that class I (non-sterile, non-measurement) Medical devices do not have NB involvement. However, if these devices are also covered by the PPE regulation and categorized in category II or III, these devices would need NB involvement from a PPE-designated NB only.


Transport of devices during the COVID-19 crisis

The European Commission has issued a recommendation to implement Green Lanes under the Guidelines for border management measures to protect health and ensure the availability of goods and essential services during COVID-19. Free movement during COVID-19 is allowed in case of critical workers and medical device engineering professionals or other essential infrastructures. More information can be found here.

The implementation of Green Lanes should make it easier for EOs in and outside the EU to transport devices that are critical during this COVID-19 crisis.

Updated on 10 June 2020.

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