Simple tongue depressors and bedpans to complicated programmable pacemakers and closed loop artificial pancreas systems are examples of medical equipment. Medical devices also include in vitro diagnostic (IVD) goods such reagents, test kits, and blood glucose metres. Medical devices include certain radiation-emitting electronic goods that have a medical application or make medical claims. Diagnostic ultrasound products, x-ray equipment, and medical lasers are examples of these.
The Regulations on Medical Devices (Regulation (EU) 2017/745) and In-Vitro Diagnostic Devices (Regulation (EU) 2017/746) altered the European legal framework for medical devices, introducing new responsibilities for the EMA and national competent authorities in the evaluation of certain categories of medical device.
Following a four-year transition period, the Medical Devices Regulation goes into effect on May 26, 2021. When releasing new medical equipment to the market, manufacturers must follow the Regulation. Directive 93/42/EEC on medical devices and Directive 90/385/EEC on active implanted medical devices are repealed.
Following a five-year transition period, the In-Vitro Diagnostic Devices Regulation will take effect on May 26, 2022. In the meanwhile, producers can choose to market in-vitro diagnostic equipment under Directive 98/79/EC or the new Regulation.
Medical devices with an ancillary medicinal substance
An auxiliary medicinal ingredient may be present in medical equipment to help it perform properly. These items are covered by medical device regulations and must be CE labelled.
Medical devices containing an auxiliary medicinal ingredient include the following:
- stents with drug-eluting properties.
- antibiotic-containing bone cement
- catheters impregnated with heparin or an antibiotic.
- Condoms impregnated with spermicide
Medical Devices regulation change post Brexit
The UK legally exited the EU on January 31, 2020, starting a transition or implementation phase aimed to lessen the impact on businesses and give the UK and EU time to finalise future trading relationship arrangements. At the same time, a new respiratory ailment emerged in China that would have far-reaching consequences for the rest of the world.
The MDR was supposed to replace the existing European rules on non-IVD medical devices in 2020. This amendment, scheduled for May of that year, was also meant to become British legislation at the same time, providing a seamless transition for medical equipment.
The UK Medicines and Healthcare Products Regulatory Agency (MHRA) has issued a fresh public consultation on a potential post-Brexit regulatory framework for medical devices, which is set to go into force in 2023.
The new consultation seeks feedback from stakeholders on planned changes to the UK's Medical Devices Regulations 2002 as part of a broader transition away from European Authorized Representative Union legal and regulatory systems; beginning in July 2023, the MHRA will no longer accept EU CE Marking for medical devices, instead requiring manufacturers to obtain UK Conformity Assessment (UKCA) marking in order to legally sell their devices in England, Scotland, Wales, and (with special consideration) Northern Ireland.
Recognition of UKCA MARK for Medical Devices
The UKCA mark will only be recognised in the United Kingdom. Existing UK Notified Bodies have been designated as "Approved Bodies" and may now carry out the UKCA mark procedure. They are no longer able to grant CE Mark.
Furthermore, the UKCA mark is not recognised in the markets of the EU, EEA, or Northern Ireland.
UK Responsible Person Approved Bodies can undertake conformity assessments in respect to the UKCA mark for medical devices, active implantable medical devices, and in vitro diagnostic medical devices for the UK market under Parts II, III, and IV of the UK MDR 2002. (as amended). Other than for the purposes of the "CE UKNI" marking, which is valid in Northern Ireland, UK Approved Bodies are unable to undertake conformity evaluations in regard to the CE marking.
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