European Commission - Guideline on personal protective equipment/medical devices
The corona crisis has increased the need for protective equipment. The European Commission is trying to tackle this issue in various ways, most recently by a public procurement initiative for the joint purchase of masks, gloves, goggles and medical ventilators and testing kits. On 27 March 2020, the European Commission has issued a guideline on the conformity assessment procedure for (potential) manufacturers of personal protective equipment ("PPE") and medical devices ("MD") in FAQ form ("Guideline"). The Guideline explains the applicable EU legal framework and authorization and certification mechanisms for placing PPE and MD on the market.
The great majority of the products currently required falls under specific EU legislation ("harmonized products"). The products concerned are subject either to Regulation (EU) 2016/425 on personal protective equipment ("PPE Regulation") or Directive 93/42/EEC on medical devices ("MD Directive") and national implementing legislation (in Austria primarily the Medical Devices Act). Originally, the MD Directive was to be replaced on 26 May 2020 by Regulation (EU) 2017/745 on medical devices ("MD Regulation"). However, on 25 March 2020, the Commission announced its intention to postpone the applicability of the MD Regulation by one year – presumably in order not to burden companies with a changed regulatory framework in the current crisis. A corresponding Commission proposal is expected at the beginning of April 2020.
The PPE Regulation and the MD Directive
- lay down essential requirements on health, safety and performance
- are technologically neutral (manufacturers may therefore use a number of technical solutions to meet the essential requirements).
- allow manufacturers to rely on specific technical solutions, which are detailed in harmonised standards (e.g. EN 149:2001+A1:2009 for FFP-type masks and EN 14683:2019 for surgical masks, available at https://standards.cen.eu/dyn/www/f?p=CENWEB:5). Compliance with the exact specifications set out in these standards is not mandatory; however, compliance with their prescriptions allows a swifter placement on the market (since the product does not have to be re-tested once again by a third party / certification authority).
The following (very general) distinction is relevant for the present context:
1. medical devices
- of class I (e.g. examination gloves and non-sterile gowns) are subject to a "self-assessment" by the manufacturer
- of a higher risk category (e.g. surgical gloves, surgical masks) must, however, be approved by a third-party testing body.
2. personal protective equipment
- Category I includes minimal risks, such as superficial mechanical injury, damage to the eyes due to exposure to sunlight and weather conditions of a non-extreme nature. Category I includes products such as gardening gloves or sunglasses.
- Category II serves as a “fallback category” for risks that do not fall under categories I or III. Products in this category are primarily intended to provide protection against mechanical risks, such as work safety helmets and safety shoes.
- Category III only covers risks that may cause very serious consequences such as death or irreversible damage to health, relating inter alia to hazardous substances and mixtures, electric shock and harmful noise. This category includes life jackets, hearing protection and PPE to protect against chainsaw cuts.
Category II and III PPE must be tested and approved by a third-party testing body to ensure compliance with the PPE Regulation. The FFP-type masks currently under discussion are classified as PPE III and must be tested before being placed on the market.
The Commission will complement the Guidelines on a regular basis in order to address any additional questions or concerns expressed by the economic operators in relation to the abovementioned regulatory framework.
Please note: This newsletter merely provides general information and does not constitute legal advice of any kind from Binder Grösswang Rechtsanwälte GmbH. The newsletter cannot replace individual legal consultation. Binder Grösswang Rechtsanwälte GmbH assumes no liability whatsoever for the content and correctness of the newsletter.
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