With Regulation (EU) 2020/561 of 23 April 2020, the transition period for the new approval of medical devices in accordance with Directives 93/42/EC and 93/385/EEC has been extended by one year. Such products must then comply with the new Medical Devices Directive EU 2017/745 (MDR). The 98/79/EC for In Vitro Diagnostics will be replaced by the EU Regulation 2017/746 (IVDR). Manufacturers will have two years longer to implement the new conformity assessment procedure.
The changes in deadlines do not affect the period during which products authorised under the "old" directives may still be made available in the market. The period of time during which they can be made available in the market can thus be shortened.
Experts agree that the new regulations will result in significantly increased labour costs for manufacturers. It seems to us both appropriate and promising to slowly start setting the course now towards conformity with the new Medical Devices Regulations, because the transition period for medical devices ends on 26 May 2020 (for In Vitro Diagnostics on 26 May 2022).
Is it possible to briefly outline the innovations?
Unfortunately not. It is, as so often, quite complex. For example, we’re working internally on a correlation table between the old directives and the new regulations, but we could just as easily start with a brand new matrix: For example, the number of articles to be observed in the new MDR has increased more than five-fold; from 23 to 123.
In summary, however, it can be clearly stated that, due to the increased number of articles to be observed and the increased complexity of existing articles, the associated procedures have also become considerably more extensive. As a result, documentation-related process steps on the way to having a certified medical device are also affected:
- Analysis and interpretation of the rules and regulations
- Transfer of requirements into requirements management
- Conformity assessment procedure (internal)
- Creation and continuous updating of technical documentation (including Instructions for Use)
- Auditing of the conformity assessment procedure and the required documentation
What does this ultimately mean for the Instructions for Use?
Here, too, a great deal has already happened in purely statistical terms: whereas in 93/42/EC the requirements which explicitly referred to Instructions for Use still ranged from "a)" to "q)", in the new Regulations these now range from "a)" to "ab)". But here as well, in addition to the numerical increase, there has also been an increase in complexity. In the context of this blog, we would like to illustrate this with just one example, albeit a representative one:
Whereas the old Medical Devices Directive on the subject of "Disposal" only required "precautionary measures to be taken in the eventthat a product posed a special or unusual hazard with regard to its disposal" to be stated in the Instructions for Use, the current requirement appears to be more complex, upon first glance:
"Warnings or cautions to be taken into account for the safe disposal of the product, its accessories and any consumables used. This information may cover the following areas:
- infections or microbiological hazards such as explants, needles or surgical devices contaminated with potentially infectious agents of human origin
- physical hazards such as sharp edges. If no Instructions for Use are required in accordance with Section 23.1(d), this information shall be made available to the user upon request."
It’s also interesting in this context that the authors of the new Medical Devices Ordinance once again attach great importance to optimised usability: "In particular, the Instructions for Use must be written in such a way that they are understood by the intended user without difficulty and, if necessary, supplemented with drawings and diagrams.” (for our terms, clearly more insistent than creators of comparable regulations in other industries). It’s fitting that with the new 82079-1:2019, another standard has just been published that not only stresses usability, but also wants it to be tested and lived.
If, as a manufacturer of medical devices, you’re considering tweaking your documentation processes and Instructions for Use concept anyway, the timing could hardly be better.