Uk Responsible Person Agreement Template
The manufacturer`s information includes the name, address and contact person of the organization In the first step, you will receive ready-made templates from us. These contain information about your company and the medical devices you want to register in the UK. We can register up to 100 product groups (grouped by GMDN codes) per registration with a maximum of 20,000 items via the MHRA database. The cost of registration in the UK is £100 per registration. In addition, according to the UK MDR 2002, technical documentation must be provided to your UK official if required by the UK authority. We first check the status of your technical documentation for timeliness and completeness, we are happy to provide you with your feedback and, if necessary, we help you fill in the gaps. A person responsible for the United Kingdom must have registered his or her registered office in the United Kingdom “where the service of a document relating in any way to the placing on the market of the product in question by the person is effective”. Although the Guidelines use the term `person`, a natural person (i.e. an individual entrepreneur) and a legal person (i.e. a business) can be referred to as the responsible person in the UK.
UK-based importers who have obtained the necessary prior authorisation from the medical device manufacturer can become UK controllers. Written evidence in the form of a contract must be signed between the manufacturer and the responsible person in the UK in support of its position. This proof must take the form of a crushed designation letter or a signed contract indicating the name and address of the company for the foreign manufacturer and the person responsible in the UK. Regulation 60 of the United Kingdom MDR 2002 (as amended by the United Kingdom MDR 2019) states that a responsible person of the United Kingdom may be prosecuted as a person who places the product on the market for the purposes of the Regulation. Since the United Kingdom`s MDR 2002 (as amended by the United Kingdom`s MDR 2019) are safety regulations for the purposes of the Consumer Protection Act, it is possible that a responsible person in the United Kingdom may be prosecuted under the Regulations or the Consumer Protection Act 1987 if he or she fails to fulfil any of his or her obligations. It is also possible that a person will be held responsible. Product details include the specific name of the device (brand/trademark/common name), device model(s), catalog number(s), contraindications, and critical warnings. For manufacturers with a large product portfolio, the MHRA has provided a special template for “bulk download” that allows all information to be uploaded to the database. As you fill out the templates that are sent to you, we will review your files. You can always contact us throughout the registration process and we will be happy to help you clarify any questions you may have about how best to prepare your registration information. Once all the templates are ready, your work is done. After returning the completed models and verifying the information received, registration in the MHRA database begins.
Manufacturers must determine whether there are any responsibilities for post-market surveillance for which the UK responsible person is jointly responsible. Those responsibilities should be clearly defined in the mandate established between the manufacturer and the responsible person in the United Kingdom. The manufacturer is always required to fulfil all its obligations, regardless of what the UK responsible person is responsible for. At the end of the 11-month transition period, the UK separated from the EU on 1 January 2021 after years of arduous negotiations. In order to facilitate trade between the EU and the UK, the agreement contains certain provisions for the medical technology industry. The Medical Devices Regulations 2019 (UK MDR 2019) amended the existing Medical Devices Regulations 2002 (UK MDR 2002) to create this new role. The UK MDR 2019 defines `UK responsible person` as `a person established in the UK acting on behalf of a manufacturer established outside the UK in relation to certain tasks related to the manufacturer`s obligations under those regulations`. This includes registration with the MHRA before a medical device is placed on the UK market. Depending on the risk category of the medical device, manufacturers outside the UK will have the option to appoint a responsible person in the UK between four and 12 months after a no-deal Brexit.
Since all medical devices must be registered with the MHRA after the withdrawal date before being placed on the UK market, manufacturers benefit from this grace period. These enhancements are included in the Registration Guidelines to allow time to comply with the new registration process. The BRITISH FP must have access to the technical documentation in one way or another. This can be a printed or electronic copy or a link to the manufacturer`s documentation system. Qserve prefers to have a contact person at the manufacturer who is available for UK PR to answer and discuss specific questions about technical documentation and where to find it, as well as for vigilance and incidents. The MHRA is responsible for the designation and oversight of the UK`s conformity assessment bodies. From this stage, you, as a manufacturer, are almost completely detached from the process. We transmit all information via the MHRA database and are in contact with the English authority for you. After a successful submission, we will receive feedback from the English authority as soon as possible. Thus, you are officially registered with us in the UK in three steps and can continue to market your products smoothly and safely. The products concerned which have themselves been certified against the CE marking before those dates may continue to be placed on the MARKET on the UK market, provided that their certificates remain valid for the EU market under the transitional provisions of the EU MDR and the EU IVDR. This guide is divided into sections on the different rules that apply in Britain, Northern Ireland and the EU.
Britain is England, Wales and Scotland. In cases where you achieve CE certification, you can continue to do so and put your device on the UK market by June 30, 2023. Please note that you must meet the EU DUM requirements for Class I products bearing the CE marking, which you will certify yourself from 26 May 2021. Similarly, you must meet the IVDR requirements for CE marking if you self-certify general IVDs as of May 26, 2022. These Directives apply only to medical devices and do not apply to other CE or UKCA marked devices which are subject to separate Directives. To receive our email updates, select your language, topics, and countries, then select Save. Other topics and content will follow shortly. Engagement increases and we will keep your preferences up to date as additional content is added. For more information, see the Guidelines on Conformity Assessment Bodies. Manufacturers of Class I medical devices and general IVDs may declare their products themselves to comply with the UK MDR 2002 before affixing a UKCA marking and placing the product on the UK market. The responsibilities of the UK responsible person are set out in the UK MDR 2002.
In summary, in addition to the above registration requirements, the responsible person in the UK: Please note that the accounts of former uk-based authorised representatives who have not updated their role as a UK responsible person in the MHRA registration system, as well as the accounts of all manufacturers represented from 1. January 2022 until the person responsible in the UK has updated their role. For more information on registration requirements, see the Medical Device Registration Guidelines. If you are a manufacturer based in Northern Ireland and have already registered your device with the MHRA for the purposes of the Northern Irish market, it can be placed on the UK market and does not need to be registered further in the UK. Q: Does the UK PR require access to technical documentation? Deselect this option if you don`t want to receive updates on critical or urgent developments outside of your regular email notifications. Products are governed by the Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR 2002), which transposed the guidelines listed below into UK law before the end of the transition period: For the purposes of the UK market, UK recognised organisations may carry out conformity assessments with regard to the UKCA marking. for medical devices, active implantable medical devices and in vitro diagnostic medical devices in accordance with Parts II, III and IV of the United Kingdom MDR 2002. . . .