Requirements for sub-suppliers of medical devices
Sourcing is a well-known concept and it is here to stay. Further sourcing has become a fixed element of product development and production.
Manufacturers of medical devices with sales on the international markets are constantly challenged by changing legislation, new products and possibilities offered by competitors and additionally – for some product groups – also by reduced lifetime as consequence of new or altered user requirements. Therefore, the need to constantly focus on innovation and on market approvals, which in turn is why the use of subcontractors has become ever more important. Just like the manufacturers of the finished product, the sub-suppliers must also continually develop and renew their products, so as to enable speedy development, reduced costs and increased flexibility.
Use of sub-suppliersFor small and medium-sized companies with limited resources in particular, there are great advantages to the use of sub-suppliers, if not a direct necessity in order to survive, and they are therefore especially critical in many cases to both development and production.
The widespread use of sub-suppliers places great demands on sub-supplier management. The manufacturer has an important job in ensuring that all sub-suppliers live up to the same requirements. Treating all sub-suppliers identically is not necessary and would simply be a waste of resources. A weighting of sub-suppliers and establishment of a set of requirements based on a risk assessment of the individual supplier should be made. There is then a foundation for triggering all of the potential cost savings to be gained by using sub-suppliers.
However, it is important for an efficient sub-supplier management and approval process that the requirements for the individual sub-suppliers are well-documented, and that checks are made to ensure these requirements are met. For critical suppliers it is also important that they are listed as a critical supplier with the manufacturer, and that special precautions are taken with these suppliers.
Categories of sub-suppliersTo ensure that sub-supplier management is done efficiently, sub-suppliers should be broken down into various categories, where two parameters in particular ought to be included: Critical and non-critical suppliers, as well as certified and non-certified suppliers.
Critical vs. non-criticalA supplier is defined as critical when the supplier delivers materials, components or services which can affect the safety and performance of the medical device. The individual company can however define more criteria for when a supplier can be considered as critical. This could be for example if there is only one supplier that can carry out the job, or if the supplier is located in a vulnerable area (e.g. earthquake-prone) etc.
Certified vs. non-certified
The use of sub-suppliers has the potential to optimise costs in terms of time, financing and flexibility.
One important factor in the choice of sub-suppliers and unlocking of this potential lies in certification, whereby with the use of a certified quality system, accredited services or other certificates of specific expertise, the sub-suppliers can be rightly expected to contribute towards ensuring the quality of the product. Certificates are relevant, as they are issued by a third party which audits the supplier at regular intervals in order to ensure that they continue to operate according to defined procedures and otherwise live up to those requirements laid down with the issuance of the certificate.
There is therefore excellent potential with a certified sub-supplier to:
- reduce the necessary efforts required to be able to demonstrate checks in development and production,
- have a positive influence on the manufacturer’s approval process,
- reduce the risk of having to redo things.
There is then excellent opportunities with the use of certified sub-suppliers to reduce the time spent from idea to market or perhaps simply to meet fixed schedules. For small and medium-sized companies without their own production, it is particularly advantageous to use a supplier with a certified quality assurance system, for example, where it must be expected that all documentation and processes are properly managed, as otherwise it can require large resources to demonstrate checks of processes and quality as a link in the approval process.
Requirements from legislation and standards
With the latest amendment of legislation for medical devices in Europe – Regulation (EU) 2017/745 of the European Parliament and of the Council on medical devices (MDR) from May 2017 – there has been a general tightening of requirements to manufacturers and for that documentation to be delivered as part of the approvals process. Correspondingly, many of the central standards used for the development of medical devices have also been revised. In this context the most important standard for quality management systems is ISO 13485:2016, where some of the most important changes in regard to sub-suppliers are in the section described below:
Section 4.2.33 introduces a requirement on the establishment of a Medical Device File (MDF), the content of which must demonstrate compliance with the standard. Basically, the MDF is a sort of shopping list and cookbook for the manufacture of the medical device, and the MDF is thus very comparable to the Device Master Record (DMR) known from the FDA. For manufacturers who have not previously sold products on the US market and are therefore familiar with the establishment of an MDR, the introduction of the MDF will introduce a central document with descriptions and references to how the product is manufactured, as well as the specifications that form the basis for the manufacture. An MDF must contain or refer to the product’s intended use, specifications, description of manufacture, labelling, monitoring, traceability, installation and maintenance instructions, if applicable.
Section 73 contains specific requirements for the procurement process and for verification of suppliers, including which elements should be included in the quality manual as well as the scope of inspection and coherence with the risks connected with a given sub-supplier or change to the product.
Increased pressure on sub-suppliers
Sub-supplier audits have become the norm and with the ever-increasing demands, it must also be expected that the level of detail in these audits will also increase in the future, affecting those sub-suppliers that are critical for a manufacturer the most. It can also be expected to see a link between the importance the sub-supplier has on the quality of the end product and the level of quality control which the sub-supplier must demonstrate. This is a knock-on effect of the manufacturer’s obligation, as a link in the approvals process, to demonstrate evidence of the sub-supplier’s expertise and quality level through certificates or as part of on-site audits, where the frequency of the audits is determined by how critical a supplier is and the evidence that can be provided.
The pressure on sub-suppliers of components and services for the manufacturers of medical devices is however not exclusively or solely caused by increased requirements on manufacturers as a result of legislation and compliance with standards. Among the larger manufacturers of end products in particular there is a clear trend towards passing a larger portion of the documentation load onto the sub-suppliers. This can be seen in the demand for accredited test reports of components for sub-suppliers and in requirements for certification from sub-suppliers.
A sub-supplier should no longer expect simply to deliver products, components or services of a high quality, but will also be expected to be positively involved in the manufacturer’s approvals process.
For further information, please contact Brian Hedegaard, Sales Manager, Product Compliance.