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Medical devices & in-vitro diagnostics

Every In-Vitro Diagnostics Device placed on the GB market needs to have a technical documentation in place, in accordance with the UK MDR

You must register all IVDs with the MHRA. If your product is listed in Part IV of the UK MDR 2002, Annex II or is a self-test device, you will need to contact a UK Approved Body.

1. Current regulations
2. Technical documentation
3. Northern Ireland and the NI protocol

Current regulations

Currently, devices are regulated in the UK under:

• Directive 90/385/EEC on active implantable medical devices (EU AIMDD)
• Directive 93/42/EEC on medical devices (EU MDD)
• Directive 98/79/EC on in vitro diagnostic medical devices (EU IVDD)

These directives are given effect in UK law through the Medical Device Regulations 2002 (SI 2002 No 618, as amended) (UK MDR 2002).

These Regulations (in the form in which they existed on 1 January 2021) continue to have effect in Great Britain after the transition period. This means that since 1 January 2021, the Great Britain route to market and UKCA marking requirements is still based on the requirements derived from current EU legislation and Medical Device Regulations 2002 (SI 2002 No 618, as amended) (UK MDR 2002).

Technical documentation

Manufacturers must keep technical documentation that demonstrates that their products conform to the requirements of the UK MDR.

The technical documentation must cover the following

Description: a general description of the product, including any variants (for example names, model numbers and sizes);
Raw material and component documentation: such as details of raw materials, drawings of components and/or master patterns, and quality control procedures;
Intermediate product and sub-assembly documentation: such as appropriate drawings and/or master patterns, circuits, formulation specification, relevant manufacturing methods, and quality control procedures;
Final product documentation: specifications including: appropriate drawings and/or master patterns, circuits, formulation specification, relevant manufacturing methods, quality control procedures;
Packaging and labelling documentation: packaging specifications and copies of all labels and any instructions for use;
Design verification: the results of qualifications tests and design calculations relevant to the intended use of the product, including connections to other devices in order for it to operate as intended;
Risk analysis: weighted against the benefits to the patient or user. For example, if biocompatibility is relevant (i.e. for invasive devices) you will need to compile and review existing data or test reports based on the relevant standards;
Compliance with essential requirements: one way of demonstrating that you meet specific essential requirements is by developing your product in accordance with relevant designated standards. The technical documentation needs to include a description of how each relevant essential requirement has been complied with including a list of relevant designated standards that have been applied, in full or in part, concerning the manufacture and design of the product;
Clinical evaluation in accordance with Annex X: of the relevant scientific literature currently available relating to the safety, performance, design characteristics and intended purpose of the device (required under Part II of the UK MDR 2002, Annex X (as modified by Part II of Schedule 2A to the UK MDR 2002)). The data needs to adequately demonstrate that the product fulfils its intended purpose. Guidance document MEDDEV2.7/1 describes what is expected in an evaluation. 7/1 includes guidance on deciding whether you need to do a Clinical Investigation as well or not;
Declaration of conformity: manufacturers must follow the EC declaration of conformity procedure described in Part II of the UK MDR 2002, Annex VII (as modified by Part II of Schedule 2A to the UK MDR 2002). You must do this before placing the device on the market;
Post-market surveillance, corrective action and vigilance procedure: manufacturers must immediately notify the MHRA if they find out that their device has been involved in an incident that: led to a death, led to a serious injury or serious deterioration in the health of a patient, user or other persons, might have led to death, serious injury or serious deterioration in health;
Manufacturers must communicate the MHRA of any technical or medical reason leading to the recall of a device.

Northern Ireland and the NI protocol

Based on the Ireland/Northern Ireland (NI) Protocol, valid as of 1 January, 2021, EU Regulation on Cosmetics (1223/2009) continues to apply in NI.

On this basis, we can determine the following for the regulation of cosmetics in NI post-Brexit:

Cosmetic products placed on the NI market after 1 January, 2021 must comply with EC Regulation 1223/2009 on cosmetics;
Cosmetic products manufactured in NI and shipped to the EU, or vice versa, are not considered as imported products;
Cosmetic products which are manufactured in GB and shipped to NI, or vice versa, are considered as imported products;
Cosmetic products placed on the NI market must have an EU RP
Cosmetic products placed on the NI market must be notified on the EU CPNP by the EU RP.

As a consequence of this arrangement, products can circulate freely on the island of Ireland, with the border being placed in the sea. Based on this, customs checks and tariffs will take place during the shipment of products from GB to the island of Ireland.