Posted on December 15, 2020 in
Written by: David B. Honig
Conversely, it should be clear, as part of the relevant agreement, that the PRRC has the right to express its concerns about one of its views, without adversely affecting its employment status or appointment. Manufacturers must now have someone within their organisation who bears the specific responsibility for complying with device laws. Even micro-organizations and small organizations will be required to have such a person “permanently and continuously.” For these small organizations, the PRRC must be considered a critical supplier for manufacturers` quality systems and a specific written agreement must be reached between the two parties. In particular, legal manufacturers must ensure that their suppliers comply with both mDR and provide the legal manufacturer with the information and documentation necessary to enable the legal manufacturer to in turn meet its obligations under the MDR. The requirement for a supplier to simply comply with applicable law is unlikely, both from a risk management and compliance perspective. It is considered that the competent authorities will ensure much more strictly that the regulatory obligations imposed by MDR on legal producers are properly documented in the relevant agreements of third parties. As a result, manufacturers must put in place a methodology to ensure adequate financial coverage, in most cases in the form of insurance coverage based on previous categories. Producers should also ensure that their trade agreements provide appropriate and appropriate coverage and compensation with other relevant third parties, such as subcontractors and distributors, particularly in light of the fact that they will now have their own regulatory functions in this process and that the manufacturer has entered into the agreement on the basis that the third party has the necessary know-how to carry out its new regulatory functions. The levels of liability and compensation must also be negotiated contractually with the ARs, who now assume legal liability for defective devices if manufacturers have not complied with the MDR. In my recent interactions with organizations ranging from small virtual production start-ups to well-established medical device manufacturers, I have observed considerable uncertainties about supplier quality expectations. In accordance with European directives 93/42/EEC (MDD) and ISO 13485:2016, supplier quality management is possible with few resources.
Some companies have successfully managed suppliers from a regulatory perspective with a minimal compliance approach and no on-site vendor audit. From a quality point of view, there is another story. Although the regulatory requirements are not specific, lax supplier controls pose many quality problems. With enhanced supplier control within the EU MDR (Regulation 2017/745), it is time to re-evaluate your supplier quality programme to address regulatory and quality issues. ISO 13485:2016 requires criteria for evaluation, selection, monitoring and re-evaluation of suppliers. The standard also requires that these criteria be consistent with the supplier`s ability to provide the product or service, the supplier`s performance, the effect of the device or service on the quality of the medical device and the risk profile of the medical device. Finally, the qualification requirements of supplier staff must be defined in your organizations` purchasing information. By following the recommendations made so far and preparing your suppliers for unannounced audits, you will decrease transit results against your suppliers. Here too, your approach must be risk-based, with the most important efforts being applied to your main suppliers (those that have the greatest impact on the compliance of your finished devices).