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. SAMPLING CONTAINERA VACUUM OR NON-VACUUM DEVICE, SPECIALLY DESIGNED BY THE MANUFACTURER FOR TAKING THE HUMAN BODY SAMPLE DIRECTLY AND STORING IT FOR IN VITRO DIAGNOSIS. As part of post-market surveillance support, contract manufacturers must ensure that production records and non-compliance records are easily accessible and created to facilitate verification. The contract manufacturer`s internal failure modes shall match the manufacturer`s (specification holder`s) external error modes to allow for effective verification of complaints and escalation data to CAPA, as well as validation of the probability of occurrence of FMEA and detection assumptions. A 510(k) is a pre-market application to the FDA to demonstrate that the marketed product is at least as safe and effective, i.e., substantially equivalent (SE), to a legally marketed product [21 CFR 807.92(a)(3)] that is not subject to pre-market approval (PMA). Economic operator – a manufacturer, authorised representative, importer or distributor. (a) makes a product available on the market under its name, registered trade name or registered trade mark, unless a distributor or importer enters into an agreement with a manufacturer whereby the manufacturer is identified as such on the label and is responsible for complying with the requirements of this Regulation in respect of manufacturers; The main requirement for manufacturers (specification holders) is to ensure that strong quality agreements are in place with contract manufacturers. Some of the points that should be included in the quality agreement are: Before placing a medical device or in vitro diagnostic medical device on the market, manufacturers must obtain a unique registration number (NRS), record the required information and enter it into the required electronic system.
Contract manufacturers are not required to obtain an NRS and register, except for those who combine medical devices or in vitro diagnostic medical devices into dental systems or packaging, or sterilize treatment systems or kits. In Europe, a medical device manufacturer is the company whose name appears on the label and which is responsible for the design, manufacture, packaging and labelling. The manufacturer must have a CE marking for his equipment. PERFORMANCEThe ability of a product to achieve the intended use specified by the manufacturer. For each acronym, we have also given the relative definition. Of the three European directives on medical devices – Directive 90/385/EEC on active implantable medical devices, Directive 93/42/EEC on medical devices (MDD) and Directive 98/79/EC on in vitro diagnostic medical devices – the definition of what constitutes a manufacturer is identical: MODERNISATIONThe objective of the definition of manufacturer is the complete reconstruction of a device already placed on the market or placed in force service, or the manufacture of a new device of the used equipment to bring it into compliance with MDR (EU) 2017/745 and IVDR (EU) 2017/746, as well as the revitalization of the refurbished product. CLINICAL EVIDENCEThe clinical data and performance evaluation results of a device of sufficient quality and quantity to allow a qualified assessment of the ability of the device to provide the intended clinical benefits and safety when used as intended by the manufacturer. The change control processes used by contract manufacturers shall ensure that at least one communication and feedback mechanism is in place for the manufacturer (specification holder) to assess any change in terms of its potential regulatory impact on the status of the marketing authorisation. Preferably, manufacturers should sign any amendments affecting their regulated products. Intended for use of a device as specified by the manufacturer on the label, directions for use or material, or in advertising or sales claims, and as specified by the manufacturer in the clinical evaluation. PO (economic operator)A manufacturer, authorised representative, importer, distributor or natural and/or legal person who puts a medical device into service, makes available and/or makes available on the market. `Natural or legal person responsible, in his own name, for the design, manufacture, packaging and labelling (sic) of a product before it is placed on the market, whether these operations are carried out by that person himself or by a third party on his behalf.` Manufacturer – means a natural or legal person who manufactures or completely refurbishes a product or has a device designed, manufactured or completely revised and markets that device under his name or trademark.
The requirements for CGMP are specified in the quality system regulations. They require domestic or foreign manufacturers to have a quality system in place for the design, manufacture, packaging, labeling, storage, installation, and maintenance of finished medical devices intended for commercial distribution in the United States, unless such a product is specifically exempt from QSR under the regulations, which would be listed in the specific classification regulations in 21 CFR parts 862-892. The QS regulation is contained in 21 CFR 820. Manufacturers assembling treatment systems and packaging use Article 12 of the MDD, which is discussed in more detail in this Article, as do manufacturers who place products under their own name or brand but may not be involved in the design, manufacture, packaging or labelling. DISTRIBUTORThe natural or legal person in the supply chain, other than the manufacturer or importer, who makes a product available on the market until it is put into service. A discussion is not necessary to explain to the manufacturer of conventional medical devices that in its own facilities, in its own premises, it physically manufactures the product and performs all functions: design, manufacture, packaging and labeling. However, it should be noted that all manufacturers outsource some of their manufacturing to some extent because they source components from third-party suppliers. Limited guidance has been issued on this issue. Where the class of the system or procedure requires the intervention of the notified body (sterile or measuring class I, class IIa, class IIb or class III), the manufacturer should consult the notified body on the applicability of this Article to its device. * It depends on whether the legal manufacturer has the necessary controls in place to control their contract manufacturer. In some cases, manufacturers` obligations apply to importers, distributors or other persons. Article 16 of the MDR and IVDR states: SAFETY CORRECTIVE ACTIONScorrective actions taken by a manufacturer for technical or medical reasons to prevent or reduce the risk of major accidents related to a product made available on the market.
IN VITRO DIAGNOSTIC MEDICAL DEVICE FOR PERFORMANCE STUDYDivable medical devices for in vitro diagnostics intended by the manufacturer for use in a performance study. Devices intended for non-medical research purposes shall not be considered as devices intended for performance studies. Contrary to popular belief, OBL assumes sole regulatory responsibility for the device as soon as its own name as the manufacturer appears on the device. In other words, you`re not just pointing the finger at the OEM when something goes wrong with the device. The OBL must also issue the declaration of conformity and, as manufacturer, obtain the CE marking for the product. In addition, devices that the OBL marks as its own cannot be modified by the OEM version and are usually purchased, stored and marketed only under the OBL name itself. Therefore, the marking (label and directions for use) cannot be radically changed, except for changes to the device name or trade name, or for changes to improve the label. Although not explicitly required, a functional quality management system (QMS) should be a primary consideration.
Without QMS (ISO 9001 or 13485), meeting the remaining requirements becomes difficult, if not impossible, and can hinder the product approval process for manufacturers (specification holders). An effective certified quality management system from a reputable registrar should provide the necessary structure for compliance. 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 (DHRs), policies, standard operating procedures, work instructions, validations, risk management documentation, training records, etc. Documents and records must be accessible at all times and kept in such a way as to minimise deterioration and prevent loss. Virtual manufacturers are a more recent phenomenon. Encouraged by global markets and increased quality from abroad – where labor has traditionally been a cheaper product – some manufacturers have outsourced their entire operations and operate businesses without physical production facilities.