Medical Device Certification Courses Lead and Developed by Industry Professionals

People in the medical device (MD) field should know by now that today’s 93/42/EEC medical device directive will be obsolete. It means that start-up planning to put devices will face challenges brought by the Medical Device Reporting. That is why product development plans need to include a detailed analysis of the life cycle phases of medical devices against the new Medical Device Reporting requirements.

It is imperative to realize what the term lifecycle means: all phases in the MD lifespan, from its conception to disposal and final decommissioning. That is why people need to think about the certification process during the concept development and initial brainstorming, as well as choosing the right regulatory route which will enable individuals a safe and strategical journey, from the initial brainstorming to disposal and final decommissioning.

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What is the focus of the new Medical Device Reporting?

Like most regulations, its main purpose or focus is to allow safe and effective devices to enter and remain in the European market. The potential clinical dangers for users and patients should be reduced as far as possible until positive risk-benefit examinations can be demonstrated.

As a manufacturer of these devices, companies need to keep these things in mind at all times and make this their guide when developing their technical documentation. Listed below is a simple overview of the path that will generate solid and detailed technical documentation. These details will eventually lead to the CE-mark.

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Define its intended use

It is surprising how frequently a lot of manufacturers overlook this, but it is very important that they define the intended use of their device correctly. The Global Harmonization Task Force document defines the intended use as:

The object or item, intent of manufacturers when it comes to the use of their products, services, or processes are reflected in the company’s instructions, information, and specifications.

The definition of medical devices is given in Article Two of the MDR. Documentation of the intended use of the item and checking if it falls under the MD definition is very important. To be categorized as an MD, it shouldn’t achieve its primary intended action by immunological, metabolic, or pharmacological means, but maybe helped in its functions by all means.

This report brings clarity and stability to the categorization of washers, disinfectors, and sterilizers. Furthermore, certain product categories don’t intend medical uses as defined in Article Two but will fall in the scope of the said regulation.

Determine the right conformity assessment procedure

As mentioned above, the right risk classification plays a very important part in the medical device certification process; according to Article 53 of the reporting, the possible conformity assessment procedures with reference to the important Annex of the regulation. The manufacturer needs to choose the right procedure and properly implement it.

Define risk classifications

There are seven risk classes (I, Is, Im, Ir, IIa, III). These things are based on the risk and criticality of the item on the patient, contact points, invasiveness, contact duration, and mode of application. According to need VIII, the reporting defines 22 rules.

By using one of these rules, companies need to define the risk classification of their product or services. They should not forget that they need to carefully evaluate the product’s intended use against every rule’s content. Wrong definitions of risk classifications will lead to wrong selections of conformity assessment procedures or certification routes. Next to the intended use definition, the right classification is one of the most important steps in the certification process.

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Make sure the safety of the product

The design of the product needs to make sure that the safety and intended use are met. Companies should comply with the harmonized standards, as well as common specifications, to achieve state-of-the-art safety. As defined by quality management system standards, the design inputs should cover the applicable regulatory standards and requirements.

That is why the performance, functional, safety, and usability requirements are given on the applicable harmonized standards should be considered inputs. These should be validated and verified at the right stages, as well as transformed into the right specifications.

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The crucial point would be to have an efficient, safe, and effective design procedure, which defines the verification, review, transfer, and validation stages. Manufacturers may benefit from a traceability matrix to demonstrate compliance with every applicable General Safety and Performance Requirements are given in Annex I of the standard regulation.