Regulation (EU) 2017/745 on Medical Devices was first adopted on 5 April 2017, and has been followed by a three-year transition period, scheduled to end on 25 May 2020. In the interim, the regulation is running alongside the two current directives, known as 93/42/EEC, the Medical Devices Directive and 90/385/EEC, the Active Implantable Medical Devices Directive. The new Medical Devices Regulation will subsequently supersede them both in spring 2020.
So, what is the purpose of introducing the new Medical Device legislation? These updated guidelines hope to welcome various improvements, as well as containing proposals to fix a number of shortcomings acknowledged in the current legislation.
Science and technology are constantly evolving, meaning that the field of Medical Device use is also required to do so. In order to accommodate such change, the new legislation will now encompass select Aesthetic Medical Devices (e.g. devices used for cosmetic purposes, such as tanning beds and pedicure chairs) however, this will apply only under the condition that the same attributes and safety profiles are possessed as Medical Devices, specifically, the prevention of disease.
The overall scrutiny of Medical Devices will increase as a means of reducing the potential risk to patients. Manufacturers will also be required to undergo strict post-marketing surveillance requirements, as well as a new pre-marketing analysis for high-risk devices, which will be undertaken by specialists at an EU level.
Manufacturers will be required to develop an in depth understanding of the legislation in order to prepare for the full implementation of the regulation. In the coming months, it is expected that extensive gap analysis will be performed so that any risks or deficiencies identified may be fulfilled ahead of the implementation date.
The changes to the Medical Device legislation have been proposed for several years. The new legislation will require a number of practical changes in the way that device safety management is performed.
Electronic reporting of incidents (EUDAMED Database); Periodic reports (PSUR); Safety reviews (trending and reviews of serious incidents); risk assessments; and device modifications to reduce those risks; will all feature as a summary of safety and clinical performance.
These are fundamental revisions to the existing legislation, all of which are accompanied by making a person responsible for the devices for the Company: The Person Responsible for Regulatory Compliance.
PharSafer will examine each of the key areas over the coming months and provide a detailed review of what each element means. This article is our introductory review of the legislation, so that clients can understand the new requirements.
We handle Medical Devices for many of our clients and if you need assistance in this area, please contact us to see how we can help with your global devices.Share this News item: