A number of key changes in requirements for quality management processes that may affect several Original Brand Labelers (OBLs) have been introduced recently. The updates, affecting those operating in the fields of Medical Devices and In-Vitro Diagnostic Devices, mainly concern OBLs’ current auditing system and quality management practices – extending the boundaries and giving clearer, stricter guidelines for both.
For the sake of clarity it is worth outlining that the definition of an OBL is generally accepted as any company that receives equipment made by a manufacturer with the intent of repackaging or incorporating that equipment under its own brand name. As such, an OBL is generally the body expected to place a product on the market under its own name, brand, or trade name.
As part of the updated requirements, OBLs are obligated to facilitate a quality management system (QMS) that adheres to each requirement laid out in the relevant directive – MDD 93/42/EEC in the case of OBLs working with medical devices. It is worth noting that while this doesn’t necessarily mean that a fully compliant ISO13485 system is mandatory in each case, it would certainly simplify processes in terms of harmonised standards.
Included in the new QMS requirements, the following (at a minimum) must be included in a product’s documentation (to be assessed during annual audits):
- Traceability data
- Regulatory requirements (market surveillance, vigilance, etc.)
- Quality control data
- Organisational structure for the company (including roles and responsibilities)
- Quality objectives
- Internal audit information and documentation
- Management review
- Client communications and order-processing
- Manufacturing processes (including performance testing and non-conformity information)
- Corrective and preventative actions taken by the company
- Purchasing from and control of related parties (including Original Equipment Manufacturers and other suppliers)
OBLs dealing in Class IIb and Class III medical devices are also obligated to provide design processes within the updated quality management system documentation. It is important to note that OBLs are obligated to carry out each of these processes themselves and cannot delegate to an Original Equipment Manufacturer (OEM) or any other third party. Failure to do so can result in a range of consequences for the OBL, including loss of CE certification or destruction of the product in question.
In addition to regular annual audits, a series of unannounced audits will also be required by the new updates. These audits will be carried out at the place(s) where the devices in question are manufactured – in most cases these may be the premises of an OEM. The responsibility for all audit costs falls onto the OBL as the body responsible for introducing the product to the European Market. It is important to also note that non-compliance or refusal to undergo the full unannounced auditing process (by either the OEM or the OBL) can result in a suspension of the manufacturer’s CE certification.
For more information on the new updates to quality management requirements, to learn about Obelis’ CE Marking and Authorized Representative services, or for advice on compliance with European directives, contact our team of regulatory experts today!