Medical Devices EU Regulation 2017/745 of April 5, 2017 estates in point (36) that to ensure legal certainty in respect of the obligations incumbent on economic operators, it is necessary to clarify
when a distributor, importer or other person is to be considered the manufacturer of a device.
MDR not only expands the medical device definition to a large list of products but also includes a reclassification for the old list. According to this, maybe you are a medical device manufacturer if your product is now a medical device (thinking on healthcare apps or wearable devices)
By placing your legal name and adress close to the symbol in the labelling of the product, you demonstrates your conformity with the product general safety and performance requirements and other legal requirements, such as those relating to quality and risk management and several other obligations such as clinical evaluation or vigilance reporting.
Medical device manufacturers are required to have a quality management systemm and measures in place to provide sufficient financial coverage for claim compensation for damage caused by a defective device.
But who is the actual manufacturer of a medical device product? Manufacturers of medical devices take prime responsibility for getting their products CE-marked for the European market. The manufacturer is to clarify how the company is affected: legal entities, obligation of economic operators, organisational structures and resources.
Article 2, definition (30) states:manufacturer means a natural or legal person who manufactures or fully refurbishes a device or has a device designed, manufactured or fully refurbished, and markets that device under its name or trademark; Several cases are considered:
The reprocessor of a single-use device should be considered to be the manufacturer of the reprocessed device and should assume the obligations incumbent on manufacturers under this Regulation
Medical devops manufacturing software ERP is an optimal solution to cover all the aspects that a medical device manufacturer needs.