The Medical Device Coordination Group (MDCG) has published a Q&A dedicated to conformity assessment procedures for protective equipment. The document has been developed to provide the manufacturers and other parties involved with additional information to achieve and sustain regulatory compliance. Personal protective equipment is especially important in the context of the outbreak of COVID-19. It is widely used for ensuring the protection for healthcare professionals working with the patients infected or suspected to be infected as well as for public use. The scope of the Q&A document covers various protective equipment including, inter alia, face masks, protective gloves, and coveralls.
Protective Equipment: Regulatory Background
The MDCG outlines the regulatory background in the sphere of protective equipment. It is important to mention that actually there are two regulatory frameworks to be applied depending on the particular medicinal product in question.
- In most of the cases, such products would be regulated as Personal Protective Equipment (PPE) under the Regulation (EU) 2016/425.
- At the same time, some of the protective equipment would be considered as medical devices and thus fall within the scope of regulation under the Medical Devices Directive 93/42/EEC (MDD) later to be superseded by the Medical Devices Regulation 2017/745 (MDR).
Both regulatory frameworks described hereabove set forth the detailed requirements regarding the performance of the products in order to ensure the safety of the users. In case if the product is being manufactured in accordance with the appropriate rules and requirements, it should be marked with the CE marking. Such products could be placed on the EU market without any additional restrictions or limitations.
The MDCG QA document also provides details about the applicable EU standards the protective equipment should meet in order to be allowed for marketing within the EU. In particular, the MDCG states that there are no mandatory standards to be applied. Hence, the manufacturers of personal protective equipment are allowed to apply any technical solutions they deem suitable, providing that the final product complies with the general safety and performance requirements set forth under the applicable regulations. The particular solutions the manufacturers may use are described in the applicable standards allowing the manufacturers to choose the ones that fit better. In case if the manufacturer decides to follow the appropriate standard, the final product would be deemed as one that meets the safety and performance requirements.
As an example, the QA document contains the references to the following harmonized standards:
- EN 149:2001+A1:2009 for the face masks considered as personal protective equipment, and
- EN 14683:2019+AC:2019 for the face masks considered as medical devices (e.g. surgical masks).
For sure, as it was already mentioned before, the manufacturers are free to choose any technical solution the deem to be appropriate while the use of applicable harmonized standards would allow them to reduce the regulatory burden and simplify the procedures to be performed in order to demonstrate compliance with the applicable safety and performance requirements.
One important aspect associated with the harmonized standards is related to the special testing prescribed by the standard EN 14683 which is applicable in case of protective equipment regulated as medical devices. Such testing could be performed either by a medical device manufacturer itself or by a third-party accredited laboratory. At the same time, the MDCG emphasizes that due to the fact that such tests are not required under the Medical Devices Directive, which due to the MDR implementation delay still constitutes the main regulation in the sphere of medical devices, the manufacturer may waive the appropriate requirements set forth under the standard. However, the manufacturer shall also consider that the regulating authority is allowed to perform the testing prescribed by the standard in order to verify compliance of the product in question with the applicable safety and performance requirements.
Usually, the harmonized standards should be purchased from the European standardization organizations CEN and CENELEC. However, due to specific needs existing nowadays, some of the standards (including the aforementioned standards EN 149 and EN 14683) could be downloaded by the manufacturers for free. Such a possibility has been introduced in order to simplify the access to the regulatory information to be considered by the manufacturers on all the steps of the manufacturing process.
PRO Instruments: Regulatory Background
In order to assist medical device manufacturers and other parties involved in the evaluation of medical devices, the FDA has already published several guidance documents covering various aspects related to the development, modification, and application of patient-reported outcome instruments. The list of the documents published by the FDA includes the following ones:
- “Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labelling Claims”,
- Guidelines on the Patient-Focused Drug Development,
- “Value and Use of Patient-Reported Outcomes (PROs) in Assessing Effects of Medical Devices”,
- “PRO Case Studies”, providing the examples of patient-reported outcome instruments, and
- “PRO Compendium”, a document containing a non-exhaustive list of PRO instruments used in clinical trials.
It is also important to mention that medical device sponsors (interested parties) are allowed to use patient-reported outcome instruments in the context of the development and evaluation of medical devices. The appropriate rule has been set forth by the Medical Device Development Tools program. Thus, the Center for Devices and Radiological Health (CDRH) recognizes such data as admissible evidence to be used in the context of medical device safety and performance evaluation.
The Agency emphasizes the importance of inclusion of the information collected directly from the patients to the scope of the documents to be submitted by the applicants in the course of applying for FDA approval. Such information could be also useful for the purpose of the decision-making process related to treatment and care. The authority states that the data deriving from the patient-reported outcomes instruments constitute an important source of information to be considered for benefit-risk assessment and preparation of the labeling.
EC Recommendation for COVID-related Products
Besides the aforementioned harmonized standards, the manufacturers of protective equipment shall also pay attention to the Recommendation to facilitate the rapid update of new products on the EU market issued by the European Commission earlier on March 13, 2020. According to this Recommendation, the notified bodies are instructed to give the highest priority to the products intended to be used in the COVID-related context. Such temporary extraordinary measures have been introduced by the European Commission in order to ensure and expand the uninterrupted availability of vitally important medical devices and personal protective equipment during the pandemic. The aforementioned Recommendations also provide the rules related to derogatory measures to be implemented to simplify the regulatory procedures and reduce the regulatory burden.
In accordance with the Recommendation, the regulating authority is entitled to perform the evaluation of the protective equipment in question in order to ensure it complies with the applicable safety and performance requirements. In case if this would be confirmed, the regulating authority is allowed to apply the fast-track framework to accelerate the placing of the product on the EU market. In particular, under the aforementioned rule, the first batch of the product subject to review could be marketed immediately upon receiving the approval from the regulating authority even if the products have no CE marking yet. However, the MDCG emphasizes that such placing is an extraordinary measure and thus should be limited in time.
Additional Exclusions for Personal Protective Equipment and Medical Devices
The document also describes additional rules to be applied when placing the protective equipment on the market during the pandemic. In particular, the aforementioned Recommendation prescribes that under certain conditions medicinal products could be placed on the market even without passing the conformity assessment procedure. Such an approach could be applied in cases when all the requirements below are met:
- The product in question is being manufactured in accordance with the appropriate harmonized standard, or the technical solutions used to ensure compliance with the applicable safety and performance requirements,
- The products are being purchased by the relevant Member State authorities,
- The products would be available only to the healthcare professionals,
- The products would be available only during the pandemic, and
- The products would not be marked via the usual distribution channels and made available to the users other than healthcare professionals.
Summarizing the information provided here above, the MDCG QA document describes in detail the special frameworks to be applied when placing protective equipment on the market depending on whether they are regulated as medical devices or personal protective equipment. The document also provides the manufacturers with additional clarifications regarding the special temporary and extraordinary measures introduced in order to ensure the availability of vitally important medicinal products during the pandemic.
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