MHRA Essential Requirements

The following apply to all devices¶

• The devices must be designed and manufactured in such a way that, when used under the conditions and for the purposes intended, they will not compromise the clinical condition or the safety of the patients, or the safety and health of users or, where applicable, other persons, provided that any risks which may be associated with their intended use constitute acceptable risks when weighed against the benefits to the patient and are compatible with a high level of protection of health and safety. This shall include
• reducing as far as possible, the risk of use error due to the ergonomic features of the device and the environment in which the device is intended to be used (design for patient safety), and

• consideration of the technical knowledge, experience, education and training and where applicable the medical and physical conditions of intended users (design for lay, professional, disabled or other users).

• The solutions adopted by the manufacturer for the design and construction of the devices must conform to safety principles, taking account of the generally acknowledged state of the art. In selecting the most appropriate solutions, the manufacturer must apply the following principles in the following order

  1. eliminate or reduce risks as far as possible (inherently safe design and construction),
  2. where appropriate take adequate protection measures including alarms if necessary, in relation to risks that cannot be eliminated,
  3. inform users of the residual risks due to any shortcomings of the protection measures adopted.

• The devices must achieve the performances intended by the manufacturer and be designed, manufactured and packaged in such a way that they are suitable for one or more of the functions referred to in UK MDR 2002 - Part I Section 2(1), as specified by the manufacturer.

• The characteristics and performances referred to in Sections 1, 2 and 3 must not be adversely affected to such a degree that the clinical conditions and safety of the patients and, where applicable, of other persons are compromised during the lifetime of the device as indicated by the manufacturer, when the device is subjected to the stresses which can occur during normal conditions of use.

• The devices must be designed, manufactured and packed in such a way that their characteristics and performances during their intended use will not be adversely affected during transport and storage taking account of the instructions and information provided by the manufacturer.

• Any undesirable side-effect must constitute an acceptable risk when weighed against the performances intended.

6a. Demonstration of conformity with the essential requirements must include a clinical evaluation in accordance with Annex X.

Design and construction essential requirements¶

The manufacturer will need to determine which apply to their software by reviewing Regulation 9 of UK MDR 2002. The following are likely to apply to software devices:

9.1 If the device is intended for use in combination with other devices or equipment, the whole combination, including the connection system must be safe and must not impair the specified performances of the devices. Any restrictions on use must be indicated on the label or in the instructions for use.

12.1 Devices incorporating electronic programmable systems must be designed to ensure the repeatability, reliability and performance of these systems according to the intended use. In the event of a single fault condition (in the system) appropriate means should be adopted to eliminate or reduce as far as possible consequent risks.

12.1a For devices which incorporate software or which are medical software in themselves, the software must be validated according to the state of the art taking into account the principles of development lifecycle, risk management, validation and verification.

12.4 Devices intended to monitor one or more clinical parameters of a patient must be equipped with appropriate alarm system to alert the user of situations which could lead to death or severe deterioration of the patient’s state of health.

12.9.1 Where a device bears instructions required for its operation or indicates operating or adjustment parameters by means of a visual system, such information must be understandable to the user and, as appropriate, the patient.

13.1 Each device must be accompanied by the information needed to use it safely and properly, taking account of the training and knowledge of the potential users, and to identify the manufacturer.

This information comprises the details on the label and the data in the instructions for use¶

13.3 The label must bear the following particulars. For this software device the "label" comprises the identifying information presented in this documentation and in the API/service metadata; particulars that concern physical product attributes are recorded as not applicable.

(a) the name or trade name and address of the manufacturer — applies. The manufacturer is the RCPCH, identified in this documentation.

(b) the details strictly necessary to identify the device and the contents of the packaging, especially for the users — applies. The device is identified as the RCPCH Digital Growth Charts Platform, with the specific software version exposed through the API and its OpenAPI specification.

(c) where appropriate, the word 'STERILE' — not applicable to software.

(d) where appropriate, the batch code (preceded by 'LOT') or the serial number — not applicable in the physical sense; the software version identifier provides the equivalent traceability.

(e) where appropriate, an indication of the date by which the device should be used safely, expressed as the year and month — not applicable to software.

(f) where appropriate, an indication that the device is for single use — not applicable to software.

(g) if the device is custom-made, the words 'custom-made device' — not applicable.

(h) if the device is intended for clinical investigations, the words 'exclusively for clinical investigations' — not applicable.

(i) any special storage and/or handling conditions — not applicable to software.

(j) any special operating instructions — applies. Provided in this documentation, which constitutes the Instructions for Use.

(k) any warnings and/or precautions to take — applies. Provided in the Intended Use section, the associated disclaimer, and throughout this documentation.

(l) the year of manufacture for active devices (this indication may be included in the version or release identifier) — applies via the release and version history recorded in the change-control system.

(m) where applicable, the method of sterilisation — not applicable to software.

(n) where the device incorporates, as an integral part, a medicinal substance or a human blood derivative, the relevant statement — not applicable.

13.6 Where appropriate, the instructions for use must contain the following particulars. For this software device the documentation site constitutes the instructions for use. Only the particulars relevant to a software device with a measuring function are reproduced below.

(a) the details referred to in Section 13.3 (other than those, such as the batch code, that relate only to a physical label) — applies; provided through this documentation.

(b) the performances referred to in Section 3 and any undesirable side-effects — applies; the intended performance is the calculation and display of growth-related parameters, as described in the System Definition and Intended Use sections of the Clinical Safety Case Report.

(c) if the device must be installed with or connected to other medical devices or equipment in order to operate as required for its intended purpose, sufficient details of its characteristics to identify the correct devices or equipment to use in order to obtain a safe combination — applies; the platform is intended to be integrated within host systems (EPRs, EHRs and PHRs), and integration guidance is provided in the implementer documentation.

(d) all the information needed to verify whether the device is properly installed and can operate correctly and safely, plus details of the nature and frequency of the maintenance and calibration needed to ensure that the devices operate properly and safely at all times — applies; covered by the implementer and API documentation.

(q) the degree of accuracy claimed for devices with a measuring function — applies; the platform has a measuring function, and its accuracy is evidenced by the static validation of the calculation engine against a synthetic test harness of approximately 4000 children's data, supervised by Prof Tim Cole, as described in the Clinical Safety Case Report (hazard "Incorrect centile data is returned by the API").

The intervening particulars (e)–(p), which concern matters such as implantation, reuse, sterile packaging, radiation emission, and incorporated medicinal or animal-derived substances, are not applicable to this software device.

The following are possibly applicable to software devices¶

10.1. Devices with a measuring function must be designed and manufactured in such a way as to provide sufficient accuracy and stability within appropriate limits of accuracy and taking account of the intended purpose of the device. The limits of accuracy must be indicated by the manufacturer.

10.2. The measurement, monitoring and display scale must be designed in line with ergonomic principles, taking account of the intended purpose of the device.

10.3. The measurements made by devices with a measuring function must be expressed in legal units conforming to the Units of Measurement Regulations 1986.