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Tıbbi Cihaz Medikal Ürün Tasarımı

Medical Device Medical Product Design

Medical devices are life-saving products, both figuratively and literally, designed for use in the healthcare industry. General definition; A medical device is any device, instrument, software, material or other product designed by its manufacturer specifically for diagnostic or therapeutic use and used alone or in combination, including software necessary for its correct application.

Its main purpose is diagnosis or treatment. However, it is defined as follows within the scope of its other functions:

o Accessory
o Vehicle
o Equipment
o Software

There are a number of issues that should be considered when designing medical devices. Some of these issues are listed below.

- General requirements for medical devices should be determined.
- Preparing the usage instructions step by step.
- To take measures for adverse situations that may be encountered and to indicate these measures.
- Classification, market supply, design, production, putting into service should be designed considering the dose.


Usage areas:

• Diagnosis, prevention, monitoring, treatment or alleviation of disease, or
• Diagnosis, monitoring, treatment, alleviation or redress of injury or disability; or
• The investigation, modification or replacement of an anatomical or physiological function, or
• Birth control

Apart from these, it can be used alone or in combination with another device. However, the following items are not considered medical devices.

- Products that do not provide pharmacological effects
- Products that do not provide immunological effects
- Products that do not provide metabolic effects

There are a number of regulations or systems for inspecting medical devices. These:

1. Medical Device Regulation (Official Gazette dated 07.06.2011 and numbered 27957)
2. Regulation on Active Implantable Medical Devices (Official Gazette dated 07.06.2011 and numbered 27957)
3. Regulation on Medical Diagnostic Devices Used Outside the Body (In Vitro) (Official Gazette dated 09.01.2007 and numbered 26398)

For the acceptance of a medical device design, the design must contain the following clauses.

- The device can be used to diagnose, treat or prevent a disease.
- Having a physical or mechanical effect mechanism in the areas where it is used.

The life cycle of medical devices is used as a diagram as follows:



Registration is the common denominator here. It determines the before and after placing on the market. The entire process before registration covers the pre-market offering, and the post-registration process covers the post-market offering. It is obligatory to make a clinical evaluation of all medical devices, regardless of class. No medical device can be placed on the market for which its clinical benefit has not been demonstrated. All medical devices must have a technical file. Technical file; It is a set of documents updated by the manufacturer over time, containing all the information about the product.

The items that should be included in the technical file of the product are listed below.

- Manufacturer name and address, address of production site and design location
- Declaration of Conformity
- European Representative
- GMDN code
-    Production flow chart
- List of machines used in production
- Raw material suppliers ISO Certificates
- A clear description of the product, its subtypes and models, if any, and its accessories.
- Intended use of the product
- Product label
-    User guide
- Product classification and justifications
- List of standards used
- Medical Devices Regulation / Basic Requirements (93/42/EEC, Annex?1)
- Risk analyzes
- Pre-clinical evaluation
- Product life, stability studies, packaging processes
- Technical features of the product
- Clinical data
- Clinical Evaluation Report


For medical device design approval, it is necessary to apply to notified bodies.

Medical devices should be designed and manufactured in a way that does not endanger the clinical condition or safety of patients, the health and safety of users or, when necessary, other persons when used in accordance with their intended use and conditions. This is required both legally and ethically.

- Chemical and physical analyzes, shelf life and stability studies for product safety
- Biocompatibility analysis and biocompatibility evaluation report
- It must be demonstrated by a clinical evaluation report consisting of clinical data that the medical device has achieved the performance prescribed by the manufacturer.
- Clinical research
- Clinical experiences (Case Report)
- Published or unpublished reports