Personal protective equipment or medical devices – what rules apply?

Protective equipment can be regulated by two alternative regulations, the rules for medical devices or the rules for personal protective equipment. The intended use of the products is decisive for which regulation that is applicable. If the product primarily protects the wearer and it is intended for “general use”, i.e. the product is intended to be used in both medical environments as well as in other environments, it should be considered as personal protective equipment according to Regulation (EU) 2016/425. Products intended to protect the healthcare personnel are usually regarded as personal protective equipment while products used to protect the patients are usually regarded as medical devices. However, this is decided on a case by case basis and the manufacturer shall state the intended use of a product. Respiratory protection (FFP-type face masks), eye protection and protective clothing are examples of products that can constitute personal protective equipment. In Sweden, the Swedish Work Environment Authority and the Swedish Consumer Agency are responsible for monitoring compliance with these rules, while the Swedish Medical Products Agency, and to a certain extent the Swedish Health and Social Care Inspectorate, with regard to in-house manufacturing of medical devices, has supervisory responsibility for medical devices.

Products that are specifically intended to be used in healthcare can be considered medical devices. Examples of such products are surgical face masks and examination gloves. These products must meet the requirements of the medical devices’ rules, i.e. Directive 93/42/EEC and the national rules implementing the directive. The directive will be replaced by an EU regulation (Regulation (EU) 2017/745) to be applied from 26 May 2020. However, after a proposal from the Commission, the Parliament and the Council have decided to postpone the application date by one year, i.e. it applies from 26 May 2021.

Conformity assessment – harmonised standards

For personal protective equipment as well as for medical devices, there are requirements regarding the safety and function of the products. The two regulations allow for products to be designed in accordance with so-called harmonised standards to meet these requirements. The use of harmonised standards facilitates the process of placing a product on the market in the EU. When a harmonised standard is used, the manufacturer can perform tests on its own to ensure compliance with the standard, or the manufacturer may entrust a laboratory to perform the tests. The advantage of using a harmonised standard is that the product does not need to be re-tested by a third party/certification authority before it is placed on the market, provided that the manufacturer can prove that the product complies with the standard (this however depends on the risk classification of a medical device).

Before placing the product on the market, a CE marking must be affixed to the product. By affixing the CE marking, the manufacturer assures that the product meets the essential requirements in the relevant regulations and that the product has passed the conformity assessment prescribed in these regulations.

Harmonised standards are now provided free of charge

Harmonised standards are developed by European standardisation organisations and are copyrighted. Normally, a company that wants access to a harmonised standard must purchase it from a national standardisation body. In Sweden, these standards can be purchased from the Swedish Institute of Standards (SIS). The Commission and the European Standardisation Organisation CEN have recently agreed that 14 European harmonised standards (including face masks) will be available for free download from the national organisation bodies. In Sweden this organisation is SIS. SIS will also provide certain alternative global standards free of charge.

A complete list of the standards that are now being provided free of charge is available on SIS’ website.

The Swedish Government temporarily waives the requirement for CE marking of personal protective equipment

On April 7, 2020, the Swedish Government decided to temporarily waive the requirement for CE marking of certain personal protective equipment, in order to meet the increasing demand from the healthcare sector. The Government’s decision means that personal protective equipment that does not have a CE marking can be approved by the Swedish Work Environment Authority, provided that the equipment meets the essential health and safety requirements. Furthermore, the Government has decided to temporarily remove the requirement for Swedish instructions for personal protective equipment in healthcare. The products covered by these changes include disposable overalls, aprons, gloves, thick gloves, eye protection (e.g. visors) and respiratory protection.

Anyone wishing to provide non-CE-marked personal protective equipment to so-called authorized purchasers can apply for a temporary permit from the Swedish Work Environment Authority. Authorized purchasers can e.g. be healthcare, emergency services, the Swedish Armed Forces, the Police Authority and other organisations that shall maintain public order. It may also include other personnel working to fight the virus and avoid further spread, such as professional caregivers. The equipment cannot be sold on the open market.

In the case of products where the manufacturer has initiated the conformity assessment procedure, the Swedish Work Environment Authority states:

“Manufacturers who have initiated a conformity assessment procedure of equipment in accordance with the requirements of the CE marking can apply for a temporary permit to sell the equipment during the assessment procedure. With such a permit, the equipment may be sold on the open market.”

During the Swedish Work Environment Authority’s permit procedure the products are tested and evaluated, but the tests are not as comprehensive as for CE marking. An approval shall be based on assessments of the essential health and safety requirements for each type of equipment. In addition, the quality assessment must be performed by a notified body.

A permit for personal protective equipment will be temporary and will be valid until 31 December 2020.

Commission recommendations on conformity assessment and market surveillance

On 17 March 2020, the Commission issued a recommendation that notified bodies should prioritise the testing of necessary protective equipment. It is not mandatory to use a harmonised standard, neither according to the rules for medical devices nor the rules for personal protective equipment, but there are several ways to ensure that the requirements of the respective regulations are met. The Commission stated that notified bodies should therefore assess whether products manufactured according to other technical solutions, such as those included in the WHO’s recommendations on the appropriate selection of personal protective equipment, also meet the essential health and safety requirements that are applicable.

In addition, the Commission identified two scenarios according to which a product may be placed on the market even if the conformity assessment procedure (including affixing of the CE marking) has not been completed or, in some exceptional cases, has not even been initiated. It is in accordance with these exceptions, which are described in more detail below, that the Government has temporarily waived the requirement for CE marking of personal protective equipment.

1. If a national market surveillance authority finds that the products meet the essential health and safety requirements set out in EU law, the national market surveillance authority may approve the products for the EU market even though the conformity assessment procedure (including the affixing of CE marking) has not been finalised.

2. In exceptional circumstances, products may be placed on the market even if the certification procedures have not been initiated and no CE marking has been affixed to the products, if the following cumulative conditions are met:

a) the products are manufactured in accordance with a harmonised standard or in accordance with any of the other standards specified in the WHO guidelines or according to a technical solution that guarantees an adequate level of safety;

b) the products are purchased by the relevant Member State authorities;c) the products are only made available for the healthcare workers;d) the products are only made available for the duration of the current health crisis; ande) the products do not enter the general distribution channels and are thus not made available to other users.

The Swedish Health and Social Care Inspectorate’s answer to questions about in-house manufacturing of medical devices

The Swedish Health and Social Care Inspectorate has supervisory responsibility and is the market surveillance authority for in-house manufactured medical devices, i.e. products that are initiated and manufactured by a healthcare provider and which are to be used only in the manufacturer’s own operations. On its website, it has published an answer to a question regarding in-house manufacturing of disposable visors in connection with the shortage of protective equipment. The Swedish Health and Social Care Inspectorate states that it does not have formal authority to grant an exemption from current requirements for medical devices, but that it will consider the current situation when assessing measures that will be taken by the healthcare sector in the near future. The Swedish Health and Social Care Inspectorate emphasizes that the rules on in-house manufacturing only apply to medical devices, for other protective equipment the regulations for personal protective equipment must be complied with. Regarding the possibility of deviating from the normal process for in-house manufacturing, it states:

“In the case of a medical devices, it is more reasonable to deviate from the in-house manufacturing process for a disposable visor, which only acts as a droplet shield, than a respiratory mask with filter function or other products that have special properties.”

The Swedish Health and Social Care Inspectorate further emphasizes the importance of carrying out risk assessments and to document eventual deviations from applicable regulations.

Postponed application of the EU’s new Medical Devices Regulation (MDR)

On 3 April 2020, the Commission presented a proposal to postpone the application of the EU’s new Medical Devices Regulation (MDR) for one year, i.e. to 26 May 2021. The proposal does not affect the In vitro Diagnostic Medical Device (IVDR) Regulation, which will apply from 26 May 2022. The proposal was adopted by both the Parliament and the Council and entered into force on 24 April 2020.

The Covid-19 crisis is the primary reason for the postponement, as the crisis has led to a shortage of certain medical devices. The transition to the new regulatory framework will be time-consuming for medical device companies as well as for national authorities. The Commission believes that these companies should focus on meeting the increasing demand for medical devices instead of focusing on the transition to the MDR.

Rules regarding export bans

For more information on rules currently applicable to export bans for protective equipment see this article.

State aid for inter alia testing and manufacturing of protective equipment

The Commission has recently introduced special rules for state aid for the construction and upscaling of testing facilities, up to the first industrial deployment, to develop and test products useful for managing the corona virus. These products include protective equipment. Furthermore, there are opportunities to support the manufacturing of products such as protective equipment.

See this article.

Beware of excessive pricing to avoid violating the competition rules

Due to the current shortage of protective equipment several competition authorities have announced that they will monitor companies’ pricing practices and have stated that companies should not engage in so-called abuse of a dominant position through excessive pricing. More information on this can be found on the following link.

Concluding remarks

The rules for different types of protective equipment are undergoing major changes, especially now during the crisis. It is therefore important to stay updated on the applicable rules and the temporary relaxations of the regulations that are gradually being introduced, and to be informed of the requirements that will be applicable in the future when the temporary relaxations no longer apply.