Protective equipment

There is currently strong interest among importers and distributors in importing and selling protective equipment. The Medical Products Agency has recently received a lot of questions from operators wishing to import and sell these types of products in Sweden.

The purpose determines which regulations apply

It is the manufacturer’s intended purpose with the device that determines whether a product is subject to the regulations for medical devices or personal protective equipment.

Generally, devices that are intended to protect the patient are considered to be medical devices, while devices that are intended to protect the staff are considered to be personal protective equipment (PPE). However, this must be determined on a case‍-‍by‍-‍case basis and the manufacturer must state the intended use of a device.

The devices must be CE marked and have correct labelling and user information in Swedish regardless of which of these regulatory frameworks is to be applied. The manufacturer must state the regulatory framework according to which the device has been CE marked.

Importers and distributors may not state an intended use other than that which is stated by the manufacturer. Even at these stages, you have a responsibility to ensure that devices and their marketing are correct.

Personal protective equipment

If a device is mainly considered to protect the person who uses it and is intendet to be used in both medical and other environments, it shall be considered to constitute personal protective equipment in accordance with Regulation (EU) 2016/425.

In Sweden, the Work Environment Authority is the market surveillance authority for personal protective equipment in the workplace, while the Swedish Consumer Agency is the market surveillance authority for personal protective equipment for private use.

The Swedish Work Environment Authority is also the competent authority for controls on the use of protective equipment. The Medical Products Agency therefore refers to the Swedish Work Environment Authority and the Swedish Consumer Agency which are the competent market surveillance authorities for personal protective equipment.

Personal protective equipment for general use includes, for example:

• respirator masks
• eye protective equipment
• visors/face masks
• protective clothing
• protective gloves.

General use means that they may be used both in healthcare and in other contexts.

Medical devices

Items of personal protective equipment which are intended to protect patients, but also other items of personal protective equipment that are specifically intended for healthcare, may be medical devices. They are subject to the national rules which transpose Directive 93/42/EEC and/or Regulation (EU) 2017/745.

Examples of such products are:

• surgical masks
• operating masks
• examination gloves
• certain types of gowns, coveralls and aprons.

Face mask or respirator mask?

Face masks and respirator masks can be used as an example of a demarcation issue. There are a number of designations and expressions for this protective equipment, for example face masks, masks or respirator masks.

• A face mask is an obstacle for particulates (aerosols) that are found in exhaled hair.
• Face masks are not sufficiently tight to protect the user (healthcare staff), but reduce the spreading of these aerosols to the surroundings (patients).
• Face masks are usually fastened with loops around the ears and are straight and pleated lengthways.

The documentation that accompanies a shipment of face masks must refer to the legislation for medical devices (MDD), Directive 93/42/EEC or Regulation (EU) 2017/745.

• There are many different types of respirator masks. The piece of protective equipment shown in the image is a respirator mask (filtering half mask) which filters out harmful substances such as dust, smoke, aerosols and fibres from inhaled air.
• Respirator masks are designed to be close-fitting to the face; they are usually cupped. They usually also have an exhaling valve and double straps that fasten around the head.

The documentation that accompanies a shipment of respiratory protective equipment must refer to the regulation on personal protective equipment, Regulation (EU) 2016/425.

Exemption application for medical devices

The Medical Products Agency may grant exemptions from certain requirements in the regulatory framework for medical devices such as, inter alia, the requirement for CE marking, if the purpose is to protect the patient/user’s life and health. However, the product must be capable of being used in a safe way despite the requirements in the regulatory framework not being met. Normally, an exemption will not be granted if there are equivalent CE marked products available.

On personal protective equipment in response to COVID‍-‍19

Commission Recommendation (EU) 2020/403 of 13 March 2020 on conformity assessment and market surveillance procedures within the context of the COVID‍-‍19 threat.

Export authorisation for medical protective equipment

Manufacturers wishing to export protective equipment to countries outside the EU must apply for export authorisation in accordance with Implementing Regulation (EU) 2020/402. This must not be confused with the free sales certificate.

The application is submitted to the designated authority of the Member State in which the exporter is established.  In Sweden, it is the National Board of Trade that handles this.