Medical Device legislation is the regulatory framework for all Medical Devices; including Examination Gloves.
Medical Device Regulation (MDR) EU 2017/745
The Medical Device Regulation (EU) 2017/745 is a new regulation, which replaced the Medical Devices Directive, 93/75/EEC, as well as the Implantable Medical Device Directive, in Europe, entering law on the 26th May 2021. This law is also effective in Northern Ireland due to the provisions of the Northern Ireland agreement between the EU and the UK following BREXIT.
The legislation adopted at EU level aims to safeguard the safety and health of patients and medical personnel alike, the economic and legal interests of healthcare providers and consumers, as well as offering redress and general product safety systems. The laws protect patients and medical personnel from risks that they would ordinarily not have the power to tackle; empower individuals to make clear product choices; ensure a clear and consistent approach to product claims and information; and bring about measures that directly safeguard people.
The changes to the regulatory regime in the EU was brought about in response to the PIP Breast Implant scandal, where subsequent investigations found not only fault with the manufacturer, but also significant short fallings in product surveillance and notified body monitoring.
As a result, the EU 2017/745 Medical Device regulation is much larger, with 100 more articles, much more prescriptive, and brings in new rules aimed at safeguarding patient safety.
Some of the key changes are listed below:
- Unique Device Indicator (UDI) to be phased in
- Increased Post Market Vigilance
- Authorised Representatives are now jointly responsible for the product with Manufacturer
- Unannounced Audits & Regulatory screening
- Requirements for a manufacturer to have a Quality Management System
- Person responsible for Regulatory compliance
UK Medical Device Regulation 2002, as amended
Following the UK’s withdrawal from the EU, the EU regulation EU 2017/745 was not implemented, due to the delay in implementation following the Coronavirus Pandemic. The Medical Device Regulation 2002 is based on the now withdrawn EU Medical Device Directive, 93/42/EEC.
To encourage a higher level of patient safety, additional requirements were brought in to this regulation however, such as strengthened requirements relating to post-market surveillance of products and Unique Device Indicator (UDI).
UK CA Marking
Having withdrawn from the EU, the UK has defined the regime for approval of medical devices. The UK requires that a UK CA mark is applied following conformance with regulatory requirements. This will be phased in for all UK products, depending on product type.
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