Economic operator – a manufacturer, authorised representative, importer or distributor. The issue of procurement is addressed at some level in key regulations in the US, EU, Canada and Japan. The EU specifies in the MDD that the notified body visits the manufacturer`s suppliers and/or subcontractors in “duly justified cases”. In Canada, the CMMR requires the manufacturer to provide “the name and address of the plant where the product is manufactured.” In Japan, regulations on outsourcing are not as clear, but they focus on the inspection of finished products and activities such as design, manufacturing, sterilization, storage and labeling. Such a solution can also be interesting for large established medical device manufacturers when it comes to medical devices that complement their portfolio, but are not part of their core business and do not want to build staff/know-how. The main obligation of a medical device manufacturer is to prove the conformity of the medical device with the legal requirements. Conformity may be demonstrated by carrying out the appropriate conformity assessment of the medical device. Economic operator – a manufacturer, authorised representative, importer, distributor or the person referred to in Article 22, systems and sets of procedures, requirements (1) and (3). In the EU and Canada, it is clear that the manufacturer is the one whose name appears on the label, even if all activities on behalf of the manufacturer are carried out by a third party. In Japan, it is slightly different because the term “manufacturer” is not defined. But the Japanese still make it clear that the concerns are (a) where the device is actually manufactured, and (b) that controls should be applied primarily to the finished equipment. However, the Japanese are concerned about certain processes (design, manufacture, sterilization, labeling), whether or not it is a subcontracting situation. The reason why the GHTF needs to take a leadership role is that ISO 13485:2003 contains requirements relevant to manufacturers and subcontractors.
It requires the organization to define: specifications and how they are obtained; materials and process control mechanisms; how risk management is conducted; process and product validation requirements; and inspection requirements. The new standard is recognized, but it is considered a requirement in Canada, voluntary in the EU, good but not sufficient in Japan, and irrelevant in the United States. Medical device manufacturers can assume that their quality management system is effective if they have it certified to ISO 13485. Are the manufacturer and subcontractors sufficiently controlled? Simply put, given the company`s supply chain process and activities, the answer is no. However, an important consideration is the method of control and it must be determined whether this control is appropriate for the EU and Canada. This is illustrated in Figure 4, which shows that position f is OK. Positions a and e are not acceptable. Positions (b), (c) and (d) are probably good, but need to be examined more closely. This concern is a fact because in a global supply chain, it matters (a) who is responsible for the device (whose name appears on it) and (b) where it is manufactured. These concerns are also relevant because product safety can be significantly affected by the manufacturer`s legal sourcing decisions. The contract manufacturer should be aware of the possibility of unannounced audits of suppliers and/or subcontractors by notified bodies. Some contract manufacturers, especially small organizations, may not be willing to conduct such an audit.
In this case, the manufacturer (specification holder) should assist the contract manufacturer in developing a process and procedures for unannounced audits by notified bodies. A good time for practice could be during a supplier audit. The MDR and IVDR do not directly define or address the role of the traditional contract manufacturer, which is traditionally defined as those who manufacture products for or on behalf of the specification holder. With the publication of the new European Medical Device Regulation (EU 2017/745) and the In Vitro Diagnostic Medical Devices Regulation (EU 2017/746), some companies ordering or relabelling products (OBL/PBL) are questioning whether they are considered a “legal manufacturer” of the product they sell. Much of the confusion surrounding this issue stems from the assumption that there can only be one legal manufacturer. The current Medical Devices Directive (MDD 93/42/EEC) and the In Vitro Products Directive (IVDD 98/79/EC) are not entirely clear on this issue, but their successors (MDR and IVDR) make it clear: a product can potentially have multiple legal manufacturers, and each of these manufacturers can take regulatory responsibility for that product. In Europe, a medical device manufacturer is the organization whose name appears on the label and is responsible for design, manufacture, packaging and labelling. The manufacturer must have a CE marking for his product. With the publication of the European Medical Devices Regulation (EU 2017/745) and the In Vitro Diagnostic Medical Devices Regulation (EU 2017/746), some companies that manufacture or relabel products (OBL/PBL) are questioning whether they are considered a “legal manufacturer” of the product they sell. Much of the confusion surrounding this issue stems from the assumption that there can only be one legal manufacturer.
But the MDR and IVDR are clear: a device can potentially have multiple legal manufacturers, and each of those manufacturers can take regulatory responsibility for that device. A: The manufacturer can choose whether the importer should use the same system for registration. This is possible if the importer and manufacturer are part of the same parent organization or if a company can grant guest access to an external organization. The prerequisite is that the data records are accessible – the location is not prescribed. Q: If the importer is part of the parent company (manufacturer), they must keep separate records of complaints, recalls, etc. lead? Manufacturers (specification holders) must ensure that contract manufacturers establish and maintain robust risk-based qualification and validation programmes, as these documents are verified by notified bodies. An appropriate sample size combined with risk is essential to ensure that validations show that the process will produce consistent results that meet specified specifications. The quality assurance agreement should ensure that documents and records relating to the manufacture of a medical device or in vitro diagnostic medical device are easily accessible and must be made available to the manufacturer (product specification holder) and/or the notified body upon request.
This includes Device Records (DMRs), Device History Records (DHR), policies, standard operating procedures, work instructions, validations, risk management documentation, training records, etc.