It is now time to devote oneself, if not to the study, at least to the reading of the general essential requirements for safety and performance included in Annex I of the Regulation on Medical Devices, MDR 2017/745, and In Vitro Diagnostic Medical Devices, IVDR 2017/746.
At a first glance, it appears that the number of requirements has greatly increased (from 13 of the Medical Devices Directive MDD 93/42/EEC and subsequent amendments and additions to 23 of the MDR, and from 8 of the In Vitro Diagnostic Medical Devices Directive IVDD 98/79/EC to as many as 20 in the IVDR).
This increase is in line with the reasons that led to the drafting and issuing of the regulations, briefly summarized as follows:
- Divergences among the national regulatory systems of the European Union Member States;
- Insufficient control on the operators by Notified Bodies;
- Necessity of post-market surveillance;
- Need to identify and track devices more effectively;
- Presence of increasingly innovative devices, employing hybrid technologies that get placed on the market faster and faster;
- Need to intensify patient safety and protection systems following adverse events (i.e., the PIP prosthesis scandal in 2010);
- Comparison with other non-EU systems and globalization needs.
In terms of form and content, the essential requirements contained in the MDR and IVDR provisions reflect these general objectives and are expressed in a more or less evident way in the requirements that deal with the information provided by the manufacturer, namely the instructions for use and labelling.
Be careful, though! The concept of labelling (intended as all the information provided to the patient, user or third parties concerning the device, including promotional or informative material in general) seems to have been included in the regulations.
In particular, article 7 of the MDR and IVDR refers not only to the instructions for use (IFU) and product label, but also to the information provided with the device when making it available and putting it into service, to the advertising of the devices in order to ban the use of information or images that “could lead the user or patient into error regarding the intended use, safety and performance of the device”.
Other parts of the regulations, introduce labelling requirements such as, for example, the need for importers to place their name on the device, packaging or IFUs. The same responsibility falls on those who translate the above information, re-label or re-package the product.
Labels and IFU are specifically referred to by requirements 23 of the MDR and 20 of the IVDR. Below are six points, explicitly formalized by the aforementioned regulations that correspond more directly to the general objectives:
- The information accompanying the device, necessary to identify the device itself and the manufacturer, together with all relevant safety and performance information relevant to users or other persons, must be made available, aside from being placed the device itself, on the packaging and in the instructions for use, on the manufacturer’s website as well;
- The label must contain the UDI code, as defined by the relevant legislation and the indication that it is a medical or an in vitro diagnostic medical device;
- The IFUs must contain an indication of the particular infrastructures necessary for the use of the device;
- Along with the IFUs, information that can be used to determine when the device should no longer be re-used, regarding for example the signs of degradation of the material or the maximum number of possible reuse, must also be provided;
- The IFUs should contain detailed information, warnings or precautions to be taken to facilitate the safe disposal of the device, its accessories and consumables associated with it, if any, in relation to the biological or physical risk;
- A warning should be present inside the IFUs, pointing out to the user and/or patient the need to report any serious incident that occurred in relation to the device to the manufacturer and to the competent authority of the Member State where the user and/or patient is established.
How should one prepare for the implementation of the essential requirements on the information provided by the manufacturer, as required by the MDR and IVDR?
Here are some useful tips:
- Identify the other applicable requirements within the regulations, not only considering Annex I;
- Proceed to a careful reading of Annex I, highlighting the different/modified/added essential requirements;
- Prepare a template document that can take into account all the requirements to be implemented;
- Evaluate the impact of changes/additions to other sections of the technical documentation (clinical evaluation, risk management, post-market surveillance, etc.).
When re-reading the table of essential requirements, new and unexpected opportunities for improvement in the devices protection and safety may emerge. Or maybe not … as usual, it all depends on the eyes of the beholder.
Marisa Testa
QA/RA Manager
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