Manufacturers must keep technical documentation that demonstrates that their products conform to the requirements of the UK MDR.
The Technical Documentation must cover all the below:
- 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.
Source: Guidance on Class I Medical Devices.