Software in Medical Devices, by MD101 Consulting - Tag - IVDRBlog about software medical devices and their regulatory compliance. Main subjects are software validation, IEC 62304, ISO 13485, ISO 14971, CE mark 93/42 directive and 21 CFR part 820.2024-03-18T07:25:39+01:00Cyrille Michaudurn:md5:9c06172e7cd5ed0f5b192883b657eabbDotclearIs my software in class IIa, IIb, or III, Dark Fateurn:md5:95414fcca7d802573d176580ed925d022019-10-31T14:03:00+01:002019-10-31T14:03:00+01:00MitchRegulationsCE MarkClassificationIMDRFIVDRMDR<p>Here we are! <a href="https://en.wikipedia.org/wiki/Papal_conclave#Smoke_colors">White smoke</a> over the European Parliament! The MDCG 2019-11 guidance on qualification and classification of medical device software (MDSW) was published the 11th of October 2019.</p> <p>This guidance could compete with a FDA guidance, if there were an international contest of MD guidances. Similar structure, with definitions and reminders on the regulatory context, with plenty of examples, a bit verbose ... like a FDA guidance.<br /></p>
<h4>No surprise on qualification</h4>
<p>The MDCG 2019-11 reuses the successful receipt of the <a href="https://blog.cm-dm.com/post/2016/08/10/MEDDEV-2.1/6-2016">MEDDEV 2.1/6</a>: decision trees to qualify software as a medical device: one for MDSW and one for IVD SW. The decisions trees were adapted to the changes of the MDR/IVDR, compared to the MDD/IVDD. But there is no fundamental change: a software qualified as a SAMD for the MDD, remains qualified as a SAMD. Conversely, it's highly probable that software not qualified as SAMD with regard to the MDD will remain outside the scope of the MDR.<br />
For this reason, and without any surprise, we retrieve almost the verbatim of the examples found in the MEDDEV 2.1/6.<br />
<br />
The guidance also brings clarification on how to qualify SAMD using IVD data, either of SAMD, or of IVD SW, depending on the relevance of input data. A grey zone remains on software using both MD data and IVD data as input data. MD or IVD? We'll see in a couple of years if new examples are added to the guidance or the Manual on Borderline Classification.</p>
<h4>Annex XVI software</h4>
<p>The guidance also covers the case of software falling in devices listed in Annex XVI or their accessories. My two cents: don't try to place on the market such software right now. Wait for common specifications or guidances on Annex XVI.</p>
<h4>No surprise on classification</h4>
<p>Bid you farewell class I SAMD. The guidance doesn't resuscitate class I software and goes to a strict interpretation of the rogue, the villainous rule 11.<br />
In a last symbolic gesture, the MDCG even added at the very end of the guidance an example of class I SAMD. But it is not convincing at all. If I were the vendor of this poor software, I would claim its use for wellness only, outside the scope of the MDR, with the help of a cryptic disclaimer written by my lawyer.</p>
<h4>IMDRF SAMD categorization</h4>
<p>Probably knowing how many SAMD would be sentenced to class III with a too strict reading of rule 11, the MDCG called the IMDRF cavalry to assist them in their quest for mercy.<br />
The <a href="http://www.imdrf.org/docs/imdrf/final/technical/imdrf-tech-140918-samd-framework-risk-categorization-141013.pdf">IMDRF SAMD categorization framework</a> proposes a classification system, which is summed up in a table of the IMDRF document. This table was borrowed and amended by the MDCG, to map the MDR regulatory classes to the IMDRF classification table.<br />
<a href="https://blog.cm-dm.com/public/25-MDR-Rule-11/IMDRF_SAMD_table_and_MDCG_SAMD_table_comparison.png" title="IMDRF SAMD table and MDCG SAMD table comparison.png"><img src="https://blog.cm-dm.com/public/25-MDR-Rule-11/.IMDRF_SAMD_table_and_MDCG_SAMD_table_comparison_m.png" alt="IMDRF SAMD table and MDCG SAMD table comparison.png" style="display:table; margin:0 auto;" title="IMDRF SAMD table and MDCG SAMD table comparison.png, Oct 2019" /></a><br />
The IMDRF cagetorization scheme looks like a risk assessment policy, to establish the SAMD class:</p>
<ul>
<li>Significance of SAMD information: likelihood that wrong data from software can lead to a damage,</li>
<li>State of healthcare: severity of the damage.</li>
</ul>
<p>Thanks to this table inserted into the MDCG, it's now possible to introduce a dose of likelihood in the determination of SAMD regulatory class. E.g.: risk of death places your software in class III if we disregard the likelihood, with a strict reading of rule 11. Risk of death (critical situation) with software driving clinical management (medium significance) places your software in class IIb. Phew...</p>
<h4>"Drives or influences", "in combination"</h4>
<p>The implementing rule "drives or influence" was already a classification propeller in the MDD. It retains its characteristics in the MDR and IVDR similar implementing rules. But for SAMD, there's a risk that SAMD class is going to be boosted by rule 11.<br />
If rule 11 classes SAMD higher than the implementing rule, rule 11 wins.<br />
<br />
This is also applicable to embedded software (de facto a combination of software and medical device, see section 6.2 of MDCG 2019-11). If embedded software provides functions only inside the scope of the intended use of the hardware host, the device result of the HW+SW combination is in the class of the hardware. But if software has some more functions extending the intended use, rule 11 has to be invoked to give its judgement.<br />
Thus, a device combination of a hardware host and an embedded software, can be placed in a higher class than hardware alone, per rule 11.</p>
<h4>IVD SAMD</h4>
<p>A few words on IVD SAMD classification. The guidance doesn't bring any interpretation of IVDR classification rules. A new guidance is in preparation for IVDR classification. This makes the title of the MDCG 2019-11 a kind of misleading advertising.<br />
But we shouldn't place too high expectations on this future guidance. IVD SAMD will be placed in IVDR regulatory class B or higher, like the other IVD devices.</p>
<h4>Conclusion</h4>
<p>Class I SAMD is dead. But SAMD will rarely be in class III, with the benevolent assistance of the IMDRF categorization. Almost 100% of SAMD will require the CE certificate of a notified body, to be placed on the market. A wave of SAMD certification requests is already growing.<br />
<br />
But where are the notified bodies able to certify SAMD? Where are the regiments of technical file reviewers, qualified at the same time on MDR/IVDR and SAMD, with a real understanding of software design processes and software risk management? In the MDR limbo.</p>https://blog.cm-dm.com/post/2019/10/31/Is-my-software-in-class-IIa%2C-IIb%2C-or-III%2C-Dark-Fate#comment-formhttps://blog.cm-dm.com/feed/atom/comments/228MDR and IVDR publishedurn:md5:422e54508d20dc1d46f45200a20b3e712017-05-06T10:59:00+02:002017-05-06T10:01:29+02:00MitchRegulationsIVDRMDR <p>Hello,
The Medical Device Regulation and In-Vitro Device Regulation have been published the 5th May 2017!<br />
See the <a href="http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=OJ:L:2017:117:FULL&from=EN">Official Journal of the EU</a>.</p>https://blog.cm-dm.com/post/2017/05/06/MDR-and-IVDR-published#comment-formhttps://blog.cm-dm.com/feed/atom/comments/203