Important information about your admission procedure

As you will have gathered from various media reports, newspaper articles and statements by politicians, industry and interest groups over the past year, the events surrounding the breast implant scandal have triggered an intensive discussion. It was and is undisputed among all those involved that it is the responsibility of manufacturers to ensure the safety of medical devices. However, a need for action was also seen with regard to the approval and monitoring procedures.

As a result, DQS Medizinprodukte GmbH (DQS MED) as well as all other notified bodies in Europe, are now required to conduct unannounced audits of manufacturers and, if necessary, their major suppliers, starting this year, based on Recommendation 2013/473/EU.

We are aware that this represents an organizational and logistical burden for all involved. However, we would also like to point out that all parties involved contribute to strengthening confidence in the safety of the approval of medical devices and the systematic control of the products and their manufacturers.

In the following, we have summarized some further information and explanations on Recommendation 2013/473/EU and on the framework conditions of the unannounced audits for you.

Annex I - Product assessment
This annex describes the requirements for Notified Bodies with regard to the examination of EC design documentation and EC type examinations. This description essentially does not establish any new requirements, but specifies the previous requirements. In the past, DQS MED has already performed the examination of EC design documentation according to Annex II Section 4 of Directive 93/42/EEC according to these criteria. Only the focus on "all" hazards intensifies the aspect of risk management and thus refers to the current version of ISO 14971.

Annex II - Quality system assessment
In essence, the descriptions refer to the performance of tests in the sampling procedure and to tests of technical documentation in general.

Since the NBOG document BPG 2010-3 was published, a guideline for the determination of the sample size for inspections of technical documentation exists. Contrary to the statement of this document, which served as guidance for the Notified Bodies, the recommendation now regulates that within a certification cycle at least one product from each product subcategory is selected and tested as a sample. This will primarily affect manufacturers who have a broad product portfolio across several subcategories. However, this does not affect the requirement that, in the long term, the aim is for all of a manufacturer's technical documentation to be tested by the notified body.

Another aspect that should not be neglected is the indication that Notified Bodies are now required to carry out product tests or have them carried out should doubts arise as to the conformity of a product.

For the determination of conformity, it is also envisaged in future that the notified bodies will examine the material flow and the use of materials, both in terms of type and quality and also in terms of quantity in relation to the end products manufactured.

The concept of essential suppliers and subcontractors is also being reinterpreted. In the future, not only direct suppliers with an influence on product quality will be included, but also suppliers and subcontractors of these essential suppliers. For you as a manufacturer, this means a much more detailed and far-reaching resolution along the supply chain than was previously the case.

Also of importance in connection with the interpretations on suppliers are the aspects regarding the responsibility of manufacturers.

1. In the future, each manufacturer shall personally fulfill their obligations regardless of any partial or complete outsourcing of production to subcontractors or suppliers.

2. Manufacturers shall no longer be able to comply with the obligation to provide evidence of complete documentation by referring to the technical documentation or the quality assurance system of their subcontractors or suppliers but shall keep the relevant technical documentation themselves in a complete form.

3) In the future, manufacturers should integrate the quality assurance system of subcontractors of crucial importance and of important suppliers into their own quality assurance system.

4. Manufacturers shall in the future control the quality of the services provided and the components supplied as well as the quality of the production regardless of the length of the contractual chain between the manufacturer and the subcontractors.

Annex III - Unannounced Audits
Notified Bodies are now required to conduct unannounced audits on a planned and cyclical basis, at least every three years, on each manufacturer, with certain factors such as the risk posed by the product, non-conformities, incident reports, recalls and also complaints intended to influence the frequency of these unannounced audits.
It is essential that these unannounced audits are not carried out as a substitute for the regularly scheduled audits, but in addition to them.

The minimum duration for an unannounced audit is set in the recommendation at at least one day and should be carried out by at least two auditors.
If essential processes in connection with product creation are outsourced, it is also possible to visit the subcontractors or suppliers concerned on their premises without prior notice in order to conduct the audit there.

The focus of the unannounced audits is both the product evaluation and the evaluation of the quality assurance system. For the product evaluation, a sample, if possible from the current production, is checked for compliance with the specifications of the technical documentation, whereby the number of samples is variable depending on the complexity and the product risk and may require several samples.
With regard to the quality assurance system, it should be checked whether the activities in progress at the time of the unannounced audit with regard to product realization (e.g. production, purchasing, quality control) are carried out in accordance with the specifications documented in the system and are also suitable for meeting the regulatory requirements.

Please note that these unannounced audits are important for you as a manufacturer to maintain certification. The preparation of the company alone cannot be done as in the case of the regularly scheduled audits and therefore places a special demand on the company. It may be that important employees are not present, so that, for example, more extensive training or substitution arrangements are required to make the unannounced audit possible. Your employees can be helped by regulations on how to inform top management when a team of auditors shows up at your door unannounced. Make sure that access to production and the warehouse is guaranteed at all times and that escorts are assigned to the auditing team.
Also remember to brief your key suppliers and subcontractors of critical importance accordingly and, if necessary, add any necessary contractual provisions to enable an unannounced audit there as well.

Be prepared that an unannounced audit can take place at any time!

Francine Emakam

Francine Emakam is Team Coordinator Change Notifications & Unannounced Audits and continues to serve as lead auditor. In this position, she coordinates the certification processes according to Regulation (EU) VO 2017/745 for medical devices of classes lll and llb implants as well as product-specific changes/additions to existing medical devices of all risk classes and is in close exchange with our customers, assessors, and competent authorities.

The coordination of the planning and process handling of unannounced audits at manufacturers of medical devices complete her area of responsibility. As an internal contact person for clinical questions in the context of certification procedures, she provides advice and support to our customers and assessors. Her interests include the certification of management systems and medical devices.