The understanding and implementation of the regulatory requirements in the early stages of the product life cycle will ensure and adequate development of the medical product under development.
The definition of life cycle is reported in the ISO 14971 version 2019:
Series of all phases in the life of a medical device, from the initial conception to final decommissioning and disposal.
In this post we will go through the different phases of the product life cycle for medical device and we will discuss in details about each of these phases.
Product Life Cycle Phase 1: Concept
This phase of the product life cycle is related to the initial evaluation of possible development of commercial product. The concept may be related to an idea of a new device or a new way to use an existing device.
First of all, it is necessary to determine wether the product can be considered a medical device or not. Obviously the definition of medical device may differ based on the countries where the device will be sold and the applicable regulatory requirements of the country. For example, in Europe, the definition of medical device reported in the EU Medical Device Regulation 2017/745 is the following:
medical device’ means any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the following specific medical purposes:
— diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease,
— diagnosis, monitoring, treatment, alleviation of, or compensation for, an injury or disability,
— investigation, replacement or modification of the anatomy or of a physiological or pathological process or state,
— providing information by means of in vitro examination of specimens derived from the human body, including organ, blood and tissue donations,
and which does not achieve its principal intended action by pharmacological, immunological or metabolic means, in or on the human body, but which may be assisted in its function by such means.
The following products shall also be deemed to be medical devices:
— devices for the control or support of conception;
— products specifically intended for the cleaning, disinfection or sterilisation of devices as referred to in Article 1(4) and of those referred to in the first paragraph of this point.
In the concept phase, the intended use of the device shall also be identified, including, if possible, the patient population.
In order to proceed in a structured way with the development of the product, an initial risk analysis is needed. It is not essential to already document a real FMEA with all the scores related to probability of occurrence and severity of the harm. However, as a useful tool to facilitate the risk analysis, it is possible to use the Annex of the ISO 24971, with a series of questions that may be useful to identify and eventually mitigate the risk associated to the device.
Other aspects that need to be taken in consideration in the concept phases are the regulatory strategy associated to the device and the resources needed, in terms of personnel, infrastructure, equipment etc etc.
Product Life Cycle Phase 2: Planning
The planning phase of the product life cycle is related to the definition of the design inputs based on customer needs and technical requirements.
This phase specifically includes prototype analysis, initial testing and initial user feedback to ensure the developed product is aligned with customer expectations.
In this phase, regulatory strategy and commercial/market strategy will need to be define more in details. Requirements related to Quality Management System need to be implemented (risk management plan, design and development plan, etc).
Product Life Cycle Phase 3: Design
This phase is related to the development of product design and of manufacturing process, verification and validation.
The activities related to this third phase concern the development of the manufacturing process (including the documentation of procedure and working instructions).
From design standpoint, this phase include the design verification and validation, latter include activities such as evaluation of usability, biocompatibility and electrical safety, if the device is an active device.
Risk management documentation will need to be prepared in this phase, including risk management plan, finalization of the risk analysis and risk/benefit analysis.
The preparation of the technical file will need to be organized as, in this stage, the design shall already be completely frozen. In this context, it is important to make sure to have taken in considerations all the regulatory requirements that are applicable to the product.
Product Life Cycle Phase 4: Validation
This product life cycle phase includes final validation of manufacturing process and preparation for product introduction.
This steps involves different activities such as:
- Process validation, mainly based on the IQ/OQ/PQ technique
- Clinical investigation, based on the claims associated to the device
- Final labelling, including IFU
- Regulatory Submission
- CE marking or other market authorizations
Product Life Cycle Phase 5: Product Launch
The product can obviously be brought to the market after regulatory approval has been obtained. In this phase, training of the user of the device shall be organized, in case it is necessary.
Product Life Cycle Phase 6: Post-Market Activities
The last phase is related to post-market activities. This phase include post-market surveillance and post-market clinical follow-up. Among the PMS activities activities, complaint handling and vigilance reporting play an Important role in order to continuously evaluate the safety of the device on the market.
Normally in this phases there are as well actives related to process improvements and product improvements and the necessity to have surveillance audits to actively maintain the certification.
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