COVID-related Regulatory Background
The outbreak of the Coronavirus Disease 2019 (COVID-19) caused by the virus called “SARS-CoV-2” or the “novel coronavirus”, and further spreading of its complications and respiratory infections associated thereto resulted in a significant increase in demand on certain medical devices, such as ventilators or tests. National regulating authorities, as well as international regulating bodies, are actively taking all the measures necessary to ensure and expand the availability of vitally important medical devices to healthcare institutions and patients, and to prevent potential shortages. Nowadays medical device manufacturers face certain difficulties caused by COVID-related factors, such as quarantine and restrictive measures, that impact the ability of the manufacturer to maintain compliance with the applicable requirements. To assist medical device manufacturers in remaining compliant in spite of all the aforementioned factors, regulating authorities are implementing extraordinary and temporary rules and frameworks that would remain valid only during the pandemic. Authorities are also taking steps to ensure the higher effectiveness of the regulatory system to avoid shortages caused by regulatory issues. The European Commission is focused on notified bodies and the way they continue their operations during the pandemic.
According to the present EC guidance, depending on the type of medical devices, they could be regulated under the following frameworks:
- general medical devices could be regulated either by the Medical Devices Directive 93/42/EEC (MDD) or by the newly introduced Medical Devices Regulation 2017/745 (MDR) that is intended to fully replace the aforementioned Directive in the future.
- In Vitor, diagnostic medical devices are regulated under the Directive on in vitro diagnostic medical devices 98/79/EC (IVDD), under the In vitro diagnostic medical devices Regulation 2017/746 (IVDR).
The EC also states that in order to be eligible for marketing and use within the EU, a medical device should have a CE mark indicating that the device has successfully passed a conformity assessment and demonstrated compliance with the applicable safety and effectiveness requirements set forth by the legislation of the European Union.
Conformity Assessment Procedure
Depending on the type of medical device, the regulatory approach and associated procedures may vary. In some cases, it is necessary to apply for the conformity assessment to be carried out by a notified body. According to the EC guidance, it is necessary to perform the conformity assessment in case of:
- Class I sterile medical devices or ones with measuring function, and also Class IIa, Class IIb and Class III medical devices.
- Medical devices that constitute reusable surgical instruments,
- Self-testing medical devices,
- In vitro diagnostic medical devices (Classes A (sterile), B, C, and D).
In accordance with the applicable regulation, the conformity assessment procedures can include the following elements:
- On-site inspections and audits of the medical device manufacturer,
- Testing and examinations,
- Review of technical documentation to be provided by the manufacturer.
The procedures to be applied would be determined by the conformity assessment (notified) body depending on the type of the medical device subject to review and its class under the risk-based classification.
Availability of Notified Bodies
The main issue covered by the EC guidance is related to the availability of notified bodies. According to applicable regulations (both Directives and Regulations), conformity assessment procedures should be performed by the notified body – a specially designated entity that is eligible to perform certain types of assessment. The particular types and classes of medical devices the notified body is entitled to assess should be explicitly indicated in the scope of its designation issued by the designating authority – the national regulating authority in the sphere of medical devices.
The survey performed by the European Commission included several important aspects related to the availability of the notified bodies. The first criterion applied by the EC is the average time needed by the noticed body to initiate the procedure. According to the general rules, the whole process commences when the medical device manufacturer applies to the notified body and submits all documents required. Then, the notified body performs the initial review of the application to determine whether the documents provided by the medical device manufacturer are sufficient to assess the matter. In accordance with the responses provided by the notified bodies, in most cases, the review of the application for changes would take less time that the application for an entirely new medical device. For most of the notified bodies, it would take less than 15 days to perform the initial review of the application submitted by the medical device manufacturer. However, some notified bodies would need even more than one month to perform the same procedures. It is also important to mention that some of the notified bodies do not accept any new applications at all.
The survey performed by the EC also covered another important aspect related to the conformity assessment – the overall duration of the whole procedure. In particular, the notified bodies participating in the survey were asked to indicate the minimum time reasonably needed to carry out the whole conformity assessment process providing that the information initially provided by the medical device manufacturer is accurate and complete.
Actually, there are two different types of conformity assessment procedures that can be performed by a notified body:
- Procedures related to change notification: This is the simplest case since a notified body performs the additional assessment related to the existing certification of a medical device manufacturer already working with the notified body. This procedure could be applied if the initial medical device subject to modifications has been assessed by the same notified body.
- Procedures related to a new application for the entirely new medical device: The duration of the whole conformity assessment procedure commencing from the scratch would significantly depend on the type of the medical device in question, its class under the risk-based classification, and other important aspects. For example, for Class I sterile medical devices or ones with measuring function, the complete conformity assessment procedure could take from one to three months.
If the medical device subject to review is associated with a higher risk, the whole conformity assessment procedures would take slightly more time.
Summarizing the information provided hereabove, a survey performed by the European Commission demonstrates the estimated time necessary to carry out the conformity assessment procedures in accordance with the type and class of a medical device. This information could be used by the medical device manufacturer to plan its activity related to applying for the conformity assessment with an entirely new medical device or notifying authorities about the changes made to an existing one.
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