Essential Safety Requirements Checklist

Each medical devices should also be accompanied by or direct the user to any safety and performance information relevant to the user or any other person as.

Essential safety requirements checklist. The sprs are detailed in annex i of the mdr. Clinical condition or the safety of patients or the safety and health of users or where applicable other persons. Product safety information checklist october 2010 su2 products have to meet essential requirements also known as essential health safety requirements ehsrs in the machinery directive. Essential principles labelling and instructions for use 16 1 each medical device should be accompanied by the information needed to identify the medical device and its product owner.

Requirements regarding design and construction ii. Article 5 standards applied by. Requirement deleted clinical evaluation required per article 49 and annex xiii ii. European medical device directive essential requirements checklist european medical device directive essential requirements checklist page 1 of 22.

To demonstrate compliance with the essential health and safety requirements of the ppe regulation eu 2016 425 as contained in annex ii please complete the attached checklist as follows. Having considered the regulation requirements carefully please indicate if the essential health and safety requirements of the regulation have been. Find out what you can do now to prepare. A high level of protection for the safety and health of persons.

Compliance with the general safety and performance requirements sprs is a cornerstone in establishing conformity with the recently published medical device regulation mdr. These are listed in the annexes to the directives and repeated in the schedules of the uk implementing regulations see below. The medical device directive mdd defines the essential requirements as the requirements that every medical product has to fulfill according to the scope they belong to these essential requirements are described by directive in annex i. The uk has left the eu new rules from january 2021.

Essential health and safety requirements ehsrs of the machinery directive. The medical device regulation mdr continues this approach with the general safety. Essential requirements general safety and performance requirements. Essential requirements checklist annex i of proposed eu regulations compromise amendment for medical device ce marking identity of the device and applicable configurations variants covered by this checklist.

Essential national requirements for patient safety the essential national requirements for patient safety is a list of 20 national standards for hospitals. Demonstration of conformity with the essential requirements must include a clinical evaluation in accordance with annex x.