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 Use
Manufacturers 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 Requirements
A 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:
- Product name
- Product’s lot number or serial number
- All details needed for a user to identify the device, the contents of its packaging and the intended purpose of the device
- Contact details of the manufacturer (e.g., name and address)
- In the case of non-EU based manufacturers, the name and address of their authorised representative
- Where relevant, information per Section 10.4.5. of the MDR
- The UDI carrier referred to in Part C of Annex VII of the MDR
- An indication of any special storage or handling conditions
- A clear indication of the time limit for using the device safely, or where this is not applicable – the date of manufacture
- If the product is supplied in a sterile condition, an indication of its sterile state and method of sterilisation
- An indication if the product is for single-use
- An indication if the device is custom-made or intended for clinical investigation only
- Other warnings and precautions to be taken that need to be brought to the user’s immediate attention
User Manual Requirements for Medical Devices
By 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:
- Information in accordance with points (a), (c), (e), (f), (k), (l), (n) and (r) of Section 23.2 of the MDR;
- A detailed description of the intended purpose of the device
- The performance characteristics of the product
- Where relevant, a description of the expected clinical benefits
- A specification of any residual risks, contraindications and undesirable side-effects
- Information needed to verify the proper installation and use of the device.
- Instructions for handling sterile devices in the event of damaged sterile packaging
- Where relevant, instructions for sterilisation of supplied non-sterile devices
- The date of issue of the user manual
- Information if the device emits radiation for medical purposes
- Any requirements for special facilities or particular qualifications of the device user
- Information on the appropriate processes for allowing re-use, including cleaning, disinfection, packaging of reusable devices
- In the case of implantable products, the overall qualitative and quantitative information on the materials to which patients can be exposed
- In the case of single-use devices, information on known characteristics and technical factors that could pose a risk if the product were to be re-used.
- Any warnings or precautions that will facilitate the safe disposal of the medical device, its accessories and any consumables used with it.
- The circumstances in which the lay user should consult a healthcare professional.
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:
- invasive and come into contact with the human body
- used for aesthetic purposes
- used to administer, re-administer, transport or store medications, bodily fluids or other substances.
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:
- in vitro diagnostic medical devices
- medicinal products covered by Directive 2001/83/EC
- advanced therapy medicinal products included in the scope of Regulation (EC) No 1394/2007
- human blood, blood cells, plasma or other blood products
- cosmetic goods covered by Regulation (EC) No 1223/2009
- viable transplants, tissues or cells of animal origin, or their derivatives, or products containing or consisting of them
- transplants, tissues or cells of human origin included in the scope of Directive 2004/23/EC
- other products that contain or consist of viable biological material to achieve or support the product’s intended purpose
- food products covered by Regulation (EC) No 178/2002.
Get Help with the MDR Certification Process
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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.