Question: How should my medical devices company manage new requirements associated with Section 10.4 of the EU MDR 2017/745 and the 0.1 percent threshold for substances that are carcinogenic, mutagenic or toxic to reproduction? Although my company isn’t concerned about the risk for implantable metals, as they are tested and evaluated rigorously, we are concerned about our instruments, especially those produced by outside manufacturers.
Safety Data Sheets don’t provide the required information, and industry standards don’t require testing for trace elements — so they generally aren’t tested. We have relied on certificates of conformity, analysis and requests to vendors for threshold levels on polymers. In the case of metals, it’s more difficult; most manufacturers haven’t had stringent requirements until now and manufacture primarily for other industries.
Answer: Section 10.4 of the EU MDR requires the identification of substances. The manufacturer placing the finished product on the marketplace has to create a technical file as part of the product approval process. This identifies where any EU MDR substances may be found above the 0.1 percent weight by weight threshold within a medical device, it’s sub-assemblies at the very lowest part and must include appropriate justification. This data should be acquired from your suppliers.
To put this technical file together, your first order of business should be to identify substances in products. If your organization receives a request for information on EU MDR substances, you’ll need to provide data on any reportable substances contained in any articles you supply. The onus is on your suppliers to determine this.
To acquire the data, various conformance certificates may be collated and submitted. The Assent EU Medical Device Regulation module allows for additional documentation to be uploaded.
Please note that although it may seem like your implantable devices are compliant, under EU MDR implants are under even more scrutiny. When a patient receives an implant, the manufacturer of the implant has to provide an implant passport that identifies the product, the patient receiving an implant and data on materials used in the implant. This is managed from a central database, and used for post-market surveillance (product monitoring and recalls). Therefore, any requests relating to implant materials must be treated in the same manner as all other EU MDR requests.
Content is current as of 2019-09-13.