The same approach is already applied in the European Union, where the manufacturer must be established in the EU or establish a representative office in the EU. At the same time, due to Brexit, EU representation would no longer be sufficient to enter the UK market – the authority also stresses that the manufacturer would have to be based in the UK itself or duly appoint a representative there. In addition, the manufacturer of medical devices must carry out a conformity assessment before applying for registration in order to be allowed to use the CE marking for its products. The UK responsible person then assumes responsibility for the manufacturer in relation to the registration of the device with the MHRA. A virtual manufacturer is an organization that sources entirely from another company (sometimes referred to as an “original equipment manufacturer”) that has designed and manufactured an identical product marked UKCA/CE/CE UKNI. By indicating its own name and address on the product, the virtual manufacturer assumes legal responsibility for the medical device and is therefore considered a manufacturer under the UK Medical Devices Regulations 2002 (SI 2002 No 618, as amended). If you register equipment as a responsible person in the UK or as an authorised representative in Northern Ireland, you will also need to provide information about the manufacturer(s) you represent. The above registration process then applies. (d) details of any changes to the medical devices to be communicated to both parties, documenting the authorisation granted by the OEM if the virtual manufacturer wishes to make changes. Authorised representatives based in the UK are no longer recognised in the EU. This means that they are not able to perform tasks on behalf of the manufacturer in order to place products on the EU market. In cases where a virtual manufacturer does not own or does not hold any rights to the design of the product, notified bodies and competent authorities may accept technical documentation containing proprietary information redacted in accordance with the guidelines. Such authorisation is only possible if the redacted data in question is not necessary for a notified body or competent authority to determine whether a product complies with regulatory requirements.
If a virtual manufacturer has redacted technical documentation, that company must have contractual arrangements in place allowing the OEM to fully disclose this information to the virtual manufacturer`s notified body, thus avoiding additional agreements between the OEM and the notified body. There is currently a requirement to register with the MHRA certain medical devices (including IVDs, custom-made devices and systems or treatment kits) placed on the market in Northern Ireland. This requirement does not apply to manufacturers placing Class I medical devices or general IVDs on the Northern Ireland market if: According to the new MHRA guidelines, the registration deadlines are 1. January 2021 for manufacturers of Class I medical devices, IVDs and custom-made devices that are established in the United Kingdom or whose authorised representatives are established in Northern Ireland. UK regulators have set grace periods for other types of equipment based on their risk classifications. This applies to devices intended by the manufacturer to be sterilised before use. Manufacturers of systems and sets of procedures are required to: In the event of a dispute between a UK Recognised Body/EU Notified Body and a virtual manufacturer regarding regulatory requirements, contact the MHRA for clarification via email devices.regulatory@mhra.gov.uk. If you are a non-UK manufacturer placing an IVD on the market in Northern Ireland, you may need to designate a single responsible person in the UK in the UK. Manufacturers located outside the United Kingdom are not required to designate a responsible person from the United Kingdom to place other products on the Northern Ireland market.
UK approved bodies/EU notified bodies should note that manufacturers: Note that in practice, there is no difference between the regulatory requirements that apply to a manufacturer and a virtual manufacturer. For more information, please email our customer service centre on info@mhra.gov.uk or call 020 3080 6000. You can also contact devices.regulatory@mhra.gov.uk by email with questions. You can also contact your trade association by email: The UK`s Medicines and Healthcare Products Regulator (MHRA) has updated its guidelines for medical device manufacturers, originally published in December 2014.