Newsletter No 36 July 2023
Subject: : Supplier management in the context of the MDR
Supplier management is a structured process within the quality management system (QMS) of medical device manufacturers for the selection, qualification, monitoring and periodic reevaluation of suppliers. It is a key process to ensure consistent quality of the raw materials and subcontracted parts that are incorporated into the production process of medical devices.
This process requires joint efforts of multiple departments, with special mention to quality assurance, procurement and quality control.
Supplier management has already been one of the pillars of the QMS under the medical devices directive (MDD) and is included in the scope of ISO 13485:2016, the quality management system standard for medical devices.
Which are the requirements according to MDR?
Under medical device regulation (MDR) there are no substantial changes in the process; however, there is a reinforcement of the authority and responsibility of notified bodies (NB) in the supervision of medical device manufacturers.
On the manufacturer’s side, quality management system requirements specifically includes selection and control of suppliers and subcontractors as part of the resource management.
With regard to the notified bodies, their surveillance requirements for manufacturers include more detailed requirements concerning:
- identification of manufacturing sites, relevant suppliers and/or subcontractors of the manufacturer, their links and allocation of responsibilities among them.
- audit of the manufacturer`s purchasing controls and verification of purchasing devices.
- it is indicated for NBs to assess the controls from the manufacturer over the suppliers with influence on the conformity of finished devices.
- NB unannounced audit planning including those of subcontractors and suppliers, as applicable.
How do medical device manufacturers manage suppliers?
- Selection and qualification of suppliers
The process starts with the selection of suppliers, according to preestablished criteria such as product specifications and compatibility with further production steps, quality system of the supplier and supplier certifications, production capacity and timelines, etc. This process includes collection of supplier questionnaires and other documents.
Next step is supplier qualification, that involves risk categorization in critical/ non-critical suppliers, and risk level of critical suppliers depending on the impact on product safety and performance. This categorization determines the supplier audit requirements up to onboarding audit, scheduled in the supplier audit plan or other monitoring arrangements, along with additional documents to collect during the qualification process. It also provides an indication on the minimum safe number of suppliers/subcontractors needed for critical supplied raw materials, intermediate products or finished goods.
In case of significant supplier changes in scope of EC certification that are not legacy devices, that is all device risk classes except for class I non-sterile & no measuring function, changes need to be assessed and approved by the NB prior to implementation. This assessment may include NB audit to the supplier.
Once all requirements have been fulfilled, a quality agreement is prepared and signed by both parties to set forth obligations and responsibilities of both parties including all applicable MDR requirements.
All critical suppliers, once qualified, become listed in the approved suppliers list (ASL) and are available for order placement.
- Management and monitoring of suppliers
Qualified suppliers are being monitored and reassessed through supplier scorecards, audits, and overview in the management review.
Supplier scorecard monitoring is conducted periodically and includes items such as production capacity according to manufacturer needs, timeliness of product delivery, product quality monitored through non-conformity records, response time to supplier complaints, supplier corrective actions (SCARs) or QA requests, etc.
Audits are conducted periodically according to the audit plan that is prepared following a risk-based approach. Audits allow to identify potential issues and opportunities of improvement. They also make more visible strong processes from suppliers.
Quality agreements are reviewed as necessary due to new regulatory requirements, changes in processes or products and non-conformities detected. Typical changes due to MDR are stronger focus on change notification and approval, unannounced audits from the Notified Body or Competent Authorities, and update of regulatory references.
Suppliers are periodically reassessed, and the overview is presented at the management review. If issues are detected during the process, they are managed through SCARS and decisions are taken if necessary.
This robust process is established and maintained to consistently introduce good quality materials and parts in the production process with the aim of placing safe devices on the market.
How are the manufacturers monitored?
Medical device manufacturers are regularly audited by the Notified Body for EC certification or certificate maintenance according to MDD or MDR, as applicable according to the MDD-MDR transitional provisions. Additionally, manufacturers are regularly audited by the Certification Body for ISO 13485:2016 recertification or maintenance. The review of the supplier management system is included in the certification cycle audit plans, at the discretion of the auditing body.
This newsletter is part of our campaign to increase the sensitivity and the awareness of all our business partners, to bring more clarity around the MDR journey and challenges and opportunities around the MDR Art.22 “Systems and Procedure Packs”.
We are already today all dependent on efficient cooperation. For the MDR implementation, we require even closer collaboration to ensure we all can deliver safe supplies to hospitals and patients in the future.
We are confident we will continue to supply health care competently on customized surgical procedure sets and small kits.
Do you wish to know more about specific MDR topics? Do you have any questions or comments about STS newsletter? Write us at MDR2020@stsmedicalgroup.com.
The next MDR newsletter will be issued in September. We wish everyone a pleasant summer.
CEO STS Medical Group
Group Manager Regulatory Affairs
STS Medical Group