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.
What is EEC? Click this site for details.
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.
Visit https://www.trade.gov/ce-marking for info about CE-marking.
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 … Read More..