This post focuses on medical device labelling requirements and user manual requirements under the EU Medical Device Regulation (MDR) 2017/745. On May 26, 2021, the EU Medical Device Regulation (MDR) 2017/745 will replace the EU Medical Device Directive (MDD) 93/42/EEC, establishing a regulatory framework for better safeguarding of public health and safety. The EU MDR 2017/745 expands
requirements for medical device approvals and places additional restrictions on substances used in the design and manufacture of products to reduce possible risk to consumers. This new regulation restricts the use of certain substances known to be mutagenic, carcinogenic or toxic to reproduction above a specified threshold, as well as specific substances known to have endocrine-disrupting properties. In-scope medical devices containing restricted substances will need to carry specific
appropriate labels and precautionary instructions in addition to the general medical device labelling requirements. Non-compliance with the EU MDR can result in product recalls, fines, and even loss of EU market access. With that being said, let’s have a look at the general label and user manual requirements for medical devices under the MDR 2017/745. The following sections also provide information on what products these requirements apply to. EU MDR Requirements for Product Labelling and Instructions for UseManufacturers of medical devices must fulfil several requirements regarding the information supplied with their devices. For instance, each medical device must be accompanied by the information required to identify the device and its manufacturer and any safety and performance information relevant to the user. Such information may appear on the product’s surface, on the packaging or in the instructions for use. Medical Device Labelling RequirementsA label represents the written, printed or graphic information appearing either on the medical device itself, or on the packaging of each unit or the packaging of multiple medical devices. Manufacturers must ensure that their product labels bear all the following elements to avoid non-compliance:
User Manual Requirements for Medical DevicesBy instructions for use, it is meant the information provided by the producer to inform the user of a product’s intended purpose and proper use. The information supplied with the instructions for use must contain at least the following elements:
What Products Must Fulfil the MDR Requirements?Compared to its predecessor, the MDR 2017/745 has a wider scope of application, including products that previously weren’t considered medical devices. Overall, the new regulation covers medical devices and parts of medical devices that are:
The MDR also applies to medical devices and accessories used in clinical investigations and the groups of products without a medical purpose listed in Annex XVI (e.g., contact lenses, liposuction equipment, dermatology equipment). Products falling outside of the scope of the MDR are, as follows:
Get Help with the MDR Certification ProcessClever Compliance helps companies of any size meet the MDR requirements and get their products on the EU market. Our digital approach to CE marking medical devices, extensive experience and connections in the certification industry are some of the elements of our proven framework for success. So, if you need help with performing GAP analysis under the MDR or any other aspect of the medical device CE certification, get in touch with our team at [email protected]. We will review your case and then assign a skilled MDR compliance expert to you. Relevant links:
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