UKCA Marking & Consulting Services
As of 1st January 2021 the United Kingdom (UK) became a third country and broke away from the European Union (EU), Medical Devices & IVD (In Vitro Diagnostic) Devices sold in the UK are now required to be compliant to the UK Medical Device Regulations 2002. Medical Devices bearing the CE mark may still be sold into the UK market until the end of June 2024. The UK has replaced the CE mark with a UK specific UKCA mark to demonstrate conformity to the UK regulations. Medical Devices & IVD Devices requiring certification from a Notified Body must be certified by a UK authorised Notified Body. Class I medical device, and Class A IVD manufacturers must ensure that they are compliant with the regulations, place the UKCA mark and register their products with the MHRA. If the manufacturer is based outside of the UK then they must designate a Responsible Person to register their medical devices with the MHRA, please see our Responsible Person Service for more information on this.
New regulations are being implemented by the UK government and a public consultation on these new regulations has now completed, it is expected that the new UK regulations will be in place before the end of the 2024 deadline.
Patient Guard can assist you in ensuring that your Technical Files are in compliance with the UK regulations for the purposes of UKCA marking. Our technical file regulatory team are experts in creating new technical files for customers wanting to place a product in the UK for the first time, or converting your CE marked technical files into UKCA mark compliant technical files. We are also able to update your UKCA technical files to the new regulations that will come into force in 2024 as soon as the legislation is passed through the UK parliament and becomes law.
CE Marking & Consulting Services
For Medical Devices placed on the European Union (EU) market they must be compliant with the Medical Device Regulations (MDR) EU 2017/745, and IVD Devices must be compliant with the In Vitro Diagnostic Regulations (IVDR) EU 2017/746. Technical Files must be complaint with Annex I, Annex II and Annex III of these regulations. Each type of medical device must have its own Technical File. Knowing exactly what is needed to go into a Technical File can be confusing and may lead to non-conformities being raised by Notified Bodies if the correct information and formatting is not correct.
Its important that your technical files are created by experts within regulatory affairs to ensure that you are compliant and avoid costly mistakes. Patient Guards consultancy services are performed by experienced and fully qualified experts, Patient Guard can create your technical files for new devices or technical files that need to be converted from the old medical device directives. We can also assist you in updating your technical files as and when needed for example, if your device has been modified or its design updated, a review and update of your risk management file, reviewing and updating your files for your obligations of post market surveillance and clinical safety information.