Latest Regulatory Advice for PPE (Personal Protective Equipment)

Posted by Sally Henderson on

Overview

The PPE (Personal Protective Equipment) Regulations as set out by EU Regulation 2016/425 and European Commission Recommendation 2020/403 (dated 13 March 2020) apply to PPE which is:

a) equipment designed and manufactured to be worn or held by a person for protection against one or more risks to that person's health or safety;

b) interchangeable components for equipment referred to in point (a) which are essential for its protective function;

c) connexion systems for equipment referred to in point (a) that are not held or worn by a person, that are designed to connect that equipment to an external device or to a reliable anchorage point, that are not designed to be permanently fixed and that do not require fastening works before use. 

European Commission Recommendation 2020/403 is a temporary legislation designed by the Government to ease the supply of essential COVID-19 related PPE during this difficult time.

EU Regulation 2016/425 applies to all PPE first placed on the market from 21 April 2018.

Although the UK left the European Union on 31 January 2020, these two pieces of legislation continue to apply to the UK during the Transition Period. 

Some types of products that appear to be similar to PPE may actually be regulated as medical equipment if their main purpose is to protect others from the user (like a surgical face mask). A medical gown is a medical device if it is to protect the patient from the doctor. If it is to protect the doctor from the patient, it is PPE.


Compliance

The essential health and safety requirements (listed in Annex II of EU Regulation 2016/425) apply to all PPE within the scope of that Regulation. Under article 19, all PPE within scope must undergo a conformity assessment procedure in accordance with its risk categorisation (specified in Annex I) to demonstrate compliance with the essential requirements.

Under the easements in Recommendation 2020/403, PPE specifically necessary for protection in the context of the COVID-19 outbreak must continue to meet the essential safety requirements. However, for a limited time, provided it meets the essential safety requirements, and provided conformity assessment procedures have been started via a Notified Body, PPE can be placed on the market, even if the conformity assessment, including affixing of CE marking procedures, has not been completed.


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