The EU Medical Device Regulation 2017/745 (MDR) that went into effect May 26, 2021, presents a number of challenges for medical device manufacturers, especially makers of implantable and invasive devices.
These devices are under stricter scrutiny as compared with the prior Medical Device Directive (MDD). The MDR includes new classification rules as well as extra surveillance reports, unannounced on-site audits, and a required designated person responsible for regulatory compliance.
The chemical compliance portion of the MDR is section 10.4. It covers “devices, parts of those devices, and materials used within devices.” The devices that are in scope are those that are:
- Invasive or come into contact with the human body.
- Used to administer or re-administer medicines, bodily fluids or other substances, including gases to/from the body.
- Used to transport or store such medicines, body fluids or substances, including gases, to be (re)administered to the body.
The general safety and performance requirements for substances used in the design and manufacture of these invasive and body contacting devices are that they not contain any hazardous substances (carcinogenic, mutagenic, reprotoxin) and endocrine-disruptors (CMR/ED) at a concentration of greater than 0.1% weight by weight, unless the presence of the substance can be justified.
Many substances are regulated under the MDR, and the number will continue to increase.
Finding MDR information
The definitions and reporting requirements for reportable components in the MDR are consistent with the EU CLP regulation (EU Regulation 1272/2008). Therefore, device makers can review EU product Safety Datasheets (SDS) from their materials suppliers for information regarding the presence of any reportable components for MDR. The SDS will list any hazardous components present at a concentration of >0.1%. The MDR also limits the presence of phthalates to a concentration of 0.1%. If there is no mention of phthalates or CMR/ED substances in the SDS, then there should be no concern on that count in terms of MDR compliance for the device.
Manufacturers should look to their materials suppliers that have put the necessary product stewardship practices in place to provide this information and to monitor for ongoing developments. Such suppliers should be able to provide customers with biocompatibility test results for their materials in their unprocessed form and consult on interpreting both base level and material level biocompatibility testing.
If a chemical does contain any of the CMR/ED substances over the 0.1% threshold, the device maker must perform an analysis explaining the potential exposure, the latest scientific consensus, alternative chemical options (or lack thereof), and the risk/cost/impact trade off. The supplier of the material in question should be able to advise on this analysis.
Devices containing these substance over the 0.1% concentration must be labeled to indicate the contents on the device itself and/or on the packaging for each unit, and the device maker must disclose the information in the device technical file. Under the MDR, the information will become part of an implant card, or “passport,” that is created when a patient receives an implant. The card identifies the product, the patient, and data on materials used in the implant. This is managed from a central database and will be used for patient safety and post-market surveillance.
More areas where MDR is tougher
The MDR also reinforces the position of Notified Bodies, the independent organizations designated by an EU country to assess the conformity of higher-risk products before being placed on the market. Under the MDR, Notified Bodies are now required to carry out unannounced on-site audits and to conduct physical or laboratory tests on devices to ensure continuous compliance by the manufacturers.
There is no “grandfathered” exemption under the MDR for existing devices that are currently on the EU market. The new regulation requires recertification of all medical devices, some of which will need to be up-classified to a higher-risk class compared with the MDD. For example, certain devices that come into contact with the spinal cord will move up from class II to class III.
The MDR is also more rigorous with regard to the provision of clinical evidence for legacy implantable medical devices. Even devices with a long safety record might not meet MDR requirements if the manufacturer does not have sufficient clinical evidence to support claims of both the safety and performance. In such cases, the manufacturer will need to conduct new clinical investigations.
Another new MDR requirement – Article 15 – is that manufacturers must designate a least one person within their organization to be responsible for regulatory compliance that possesses the requisite expertise in the field of medical devices.
A final note
Chemical regulation requirements for medical devices under the MDR are separate from compliance requirements under the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) and the Restriction of the use of certain Hazardous Substances (RoHS) directives and their amendments. Devices placed on the EU market must comply with all three. The MDR lists potentially different substances than REACH, so compliance with one does not indicate compliance with the other. The recommended approach for manufacturers is to have a unified chemical management system in coordination with their materials suppliers that begins at the design phase and continues throughout the product lifecycle.
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This article is a general guide only and should not be taken as legal advice. This article was up to date as of Oct. 25, 2021. Requirements and/or interpretations may have changed since then.