EU Authorised Representative for PPE
Equipment which is intended to provide protection against one or several risks to a person’s health or safety is considered to be Personal Protective Equipment (PPE). Within the healthcare sector, this does not include devices or equipment which protect the patient from risk of harm.
Since 21st December 1989, the design, manufacture and marketing of PPE was covered by the PPE Directive 89/686/EEC. As part of the New Approach Directives, the PPE Directive defined essential requirements which must be met in order to place PPE on the EU market.
Being over 20 years old, and due to technological advancements, it was determined that this Directive should be updated. To this end, the PPE Regulation (EU) 2016/425 superseded this Directive and was adopted on 12th February 2016 and published in the Official Journal of the EU after 20 days. This started a 2 year transition period which ran out on 21st April 2018.
Changes Introduced by Regulation (EU) 2016/425
- Annex I of the Regulation presents the Risk Categories of PPE, with certain equipment being promoted to high risk categories (e.g. protection against harmful noise, life jackets). An interesting inclusion is the one for heat gloves, which were not covered by the scope of the Directive.
- A Declaration of Conformity (DoC) must now be issued with each PPE. It also allows for the provision of a link at which the DoC may be obtained.
- New or renewed certificates issued by the notified body shall not exceed 5 years.
- The obligations for importers and distributors of PPE are provided in Articles 10 and 11 respectively.
To claim conformity with the Regulation, the manufacturer must meet all the applicable Essential Health and Safety Requirements in Annex II and draft up a Declaration of Conformity. In the process, manufacturers must establish a compliant technical file for their PPE, as outlined in Annex III. Included in the technical file is the list of applicable Essential Health and Safety Requirements, design and manufacturing drawings of the PPE, applicable test reports, and a copy of the manufacturer’s instructions.
Link to Medical Devices
In certain cases, a product may be used to protect both a patient and the user of the device. For example, radiation aprons may be intended by the manufacturer to be used by either the patient or the radiographer. In this case, this device falls under both the definition of a medical device, and a PPE, and will thus need to meet the requirements of both Regulations.