Essential Requirements MDD (93/42/EEC)
This document addresses all essential requirements outlined in Annex I of the MDD. Unlike other templates, the quoted sections below directly reference the MDD, without added explanations. These excerpts represent legal text from the MDD itself, not interpretations or clarifications.
For each requirement, assess whether it applies to your product. Some assumptions for software have been pre-filled, but it is important to review each requirement carefully—particularly those regarding measuring functions (Section 10) or monitoring clinical parameters (Section 12.4).
1
Devices must be designed and manufactured so that when used as intended, they do not compromise the safety or clinical condition of patients, users, or others. Any associated risks must be acceptable when weighed against the device’s benefits and aligned with a high level of health and safety protection.
- Applicable: Yes
- Evidence of Conformity: ISO 14971:2019 (Risk Management Report), Clinical Evaluation
This includes minimizing the risk of use errors by considering ergonomic design features and the environment in which the device is intended to be used (designed for patient safety).
- Applicable: Yes
- Evidence of Conformity: ISO 14971:2019 (Risk Management Report), IEC 62366-1:2015 (Usability Evaluation Report)
Additionally, the design must account for the technical knowledge, experience, education, and physical conditions of the intended users (whether lay, professional, or with specific needs).
- Applicable: Yes
- Evidence of Conformity: IEC 62366-1:2015 (Usability Evaluation Report)
2
The device design and construction must conform to safety principles, aligning with the state of the art. The manufacturer must:
- Eliminate or minimize risks (inherently safe design).
- Implement protection measures (e.g., alarms) for risks that cannot be eliminated.
- Inform users about residual risks associated with the product.
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Applicable: Yes
- Evidence of Conformity: ISO 14971:2019 (Risk Management Report)
3
Devices must meet their intended performance as defined by the manufacturer and be suitable for one or more functions referenced in Article 1(2)(a).
- Applicable: Yes
- Evidence of Conformity: IEC 62304:2006 (Software Verification), Clinical Evaluation
4
The performance and characteristics of the device must not deteriorate to the extent that patient or user safety is compromised during the expected device lifespan, considering normal conditions of use.
- Applicable: Yes
- Evidence of Conformity: ISO 14971:2019 (Risk Management Report), IEC 62304:2006 (Software Verification & Validation)
5
Devices must be designed and packaged to ensure that their intended performance is not negatively impacted during transport or storage, considering the manufacturer’s instructions.
- Applicable: No
6
Any undesirable side effects must present acceptable risks when weighed against the device’s intended performance.
- Applicable: Yes
- Evidence of Conformity: ISO 14971:2019 (Risk Management Report)
6a
Conformity with essential requirements must include a clinical evaluation in accordance with Annex X.
- Applicable: Yes
- Evidence of Conformity: Clinical Evaluation
7-12.3
- Applicable: No
12.4
Devices used to monitor clinical parameters must include alarm systems to warn users of potential life-threatening conditions.
- Applicable: No (no monitoring features)
12.5-12.8
- Applicable: No
13
Devices must include all necessary information provided by the manufacturer to ensure safe usage.
- Applicable: Yes
- Evidence of Conformity: ISO 14971:2019, IEC 62366-1:2015 (Labelling, Instructions for Use)