The President of the Office has just announced that the use of medical devices in the form of all types of dermal fillers (such as hyaluronic acid) by individuals without formal education in healthcare or medicine is unlawful and constitutes a violation of the Medical Devices Act.
The logic of the Statement is as follows: if the instructions for a device specify that the user must be a professional, this automatically excludes laypersons. And under the #MDR, a “layperson” is defined as “a person without formal education in a relevant field of healthcare or medicine.”
This communication is extremely significant for the long-running debate over the scope of cosmetologists’ and beauticians’ competences versus the medical monopoly – and it is highly unfavorable for non-medical professionals.
We can expect that the debate will now focus on whether a “cosmetologist” can be considered a “professional” and whether the distinction between “professional” and “layperson” is indeed a logically closed and exhaustive division.
Kudos to the President for his courage! A heated public debate is certain to follow.
Together with Kamil Kistryn, we have just won a final acquittal in a criminal case against an anesthesiologist accused of endangering a patient’s life after a difficult surgery by allegedly failing to notice that more than two liters of blood had drained from the patient in the three hours following the procedure!
The medical records contained half-hourly entries documenting the readings from the drainage bags: 50 ml, 80 ml, 100 ml, 120 ml, 150 ml… and so on. The nurses carefully recorded the fluid levels based on the measurement scales on the drainage bags – in other words, every 30 minutes the amount of blood in the bag increased, as is normal after a major surgery.
The experts, however… added these values together! Seriously. 50+80+100+120+150, etc. On this basis they concluded that the doctor had shown gross negligence by failing to notice that the patient was supposedly losing massive amounts of blood. The prosecution filed charges, and the trial dragged on for more than four years. The result: acquittal at both instances.
Where is the problem? Despite clear explanations, witness testimonies, and the obvious mistake, the experts in my client’s case never withdrew their flawed findings! They refused to change their position – even in the face of indisputable facts.
Sadly, this has been my experience in many medical cases. Experts very often do not want – and do not like – to revise their initial hypothesis. Yet, experts are NOT allowed to establish facts! That is the exclusive role of the court. The expert’s task is to provide a scientific analysis of the circumstances indicated by the court, and in case of uncertainty – to present a variant analysis (“if X happened, then the evaluation is Y, but if not, then Z”).
In my view, the current practice of writing expert opinions needs significant reform. The model taught to doctors in medical schools and applied in some forensic medicine departments is flawed in this respect – and leads to unnecessary extensions of court proceedings.
A serious dilemma, which the Polish Society of Gynecologists and Obstetricians has recently brought to the Ministry of Health – namely, how should an obstetrician act when a certificate from another specialist requires termination of pregnancy, but the fetus has already reached viability – was something I had already “anticipated” in my commentary on the Penal Code edited by Radosław Tymiński.
Key excerpts from the text (4.1.11. Termination of late pregnancy for maternal reasons falling outside the scope of Article 152 § 3 of the Penal Code):
“Such dilemmas are common in medicine […]. As A. Zoll has pointed out, in such a situation the child must be saved.”
“This dramatic view completely overlooks the everyday side of medicine, where benefits and risks are constantly weighed in typical clinical situations.”
“In medical practice, no Polish obstetrician would consider the decision to terminate a pregnancy, for example in the 34th week due to increasing risk for the mother, as an ‘abortion’ within the meaning of Article 152 § 3 of the Penal Code.”
“For doctors, such an intervention is associated with terms like ‘accelerated delivery’, ‘expedited termination of pregnancy’, ‘elective completion of pregnancy’, ‘induction of labor’, etc. […] In these circumstances, the actions are understood in obstetric – not abortion – terms.”
“In my opinion, decisions to accelerate delivery in late pregnancy, involving a medically acceptable level of health risk for the child – reasonably proportionate to the risks for the mother – do not fall under the prohibition of Article 152 § 3 of the Penal Code. Rather, they belong to the sphere of actions that can par excellence be called ‘primarily lawful’. Such actions do not infringe upon the legal goods protected by these provisions and do not constitute an attack on them.”
As we are now close to the end of the consultation for the Targeted Evaluation of the MDR and IVDR for which the Commission is currently planning proposals for Q4 this year, the Dutch Ministry of Health has interestingly also published its position on the Targeted Evaluation. The one page document gives an interesting insight into the head of a member state:
Two points interest me here:
If the wish is "one representative body, with experts on medical devices that could give input on priorities, address long term development of the regulatory system and coordinate international activities to ensure consistency, predictability, sustainability and confidence" this is exactly the role that the Commission was always supposed to have under the MDR and IVDR and which is reinforced in the Liese initiative.
This idea shows that member states are still not serious about centralisation that will actually make a difference for Europe and the member states are not ready to allow the EU to profit from the policy and regulatory chaos in the US and show that the EU has a world class regulatory system and is where you launch your devices first. Let's not miss this opportunity because of this national lack of ambition that goes to the detriment of innovation and quality of healthcare.
Important #GDPR clarification by the CJEU of the concept of personal data (so relevant to personal data concerning health data too), because people confuse pseudonomised and anonymised data all the time. If you refer to data as anonymous data, you probably have missed an important nuance under EU GDPR.
Consider this example to understand the logic of the CJEU's judgment: a safe has money in it. If you lock the safe, that doesn't mean that there is no money in it anymore. You open it, and there is the money. That's why you need to treat the safe as containing money. Same with data. Only people who don't know what's in it in the first place don't have to treat the safe as containing money. Again, same with data.
Interesting developments in conditional CE certificates: a recent press release of Team-NB encourages members to continually consider the possibility of issuing certificates with specific conditions, provisions, or limitations. Why is this happening only now? The press release refers to a legal basis that exists since 2017, to MEDDEV guidance that has existed even longer and MDCG guidance from 2022 (the famous non-legislative measures guidance MDCG 2022-14).
Apparently the CORE-MD report titled ‘Reports on conditions on certificates by notified bodies Deliverable 3.3’ (31 March 2024) referenced in the Team NB press release was the ‘breakthrough’. This report has highlighted the low volume use of certificates with conditions by notified bodies under the medical device directives, but also highlighted the value of this mechanism to support innovation and pointing at its underutilization of such conditions under the MDR.
It seems that after the report’s conclusions notified bodies have finally received the go-ahead of member states that oversee them and greenlighted a more practical approach for devices that now suffer from the standard conformity assessment process in which they cannot tick all the boxes immediately, e.g. on premarket evidence: innovative, novel and orphan medical devices.
Basically the solution is to make better use of PMS/PMCF and PMS/PMPF in the MDR and IVDR, an option that I have personally been defending for years (also for example in relation to revision of the five year certification cycle). This is the easiest option to have a more proportionate market access pathway without designing new procedures, although we may see those new procedures in the MDR and IVDR’s targeted evaluation for which the Commission proposals are due Q4 of this year.
However, the option of conditional certificates does not automatically make for more (cost)efficient and predictable procedures, which is in the end what is needed to bring these devices to the market (the Liese initiative for MDR contains exactly such procedures). We will need to see how the notified bodies translate this to practice, most importantly if it will be possible to get clarity on important parameters in prior structural dialogue, a feature that is still highly problematic for nailing down a clinical strategy in advance (which would be what these devices need).
And: conditional certificates will remain exceptional, so there is still nothing like structural programs such as the breakthrough devices program in the US. But let’s be optimistic. Some movement is better than no movement, even if it concerns options that were available for years already.
As Fairfield Law Firm, we are attending today the most important conference in Poland on medical devices – “Investments in a New Future” organized by the POLMED Chamber.
A very interesting panel on (de)regulation, led by Oskar Luty, has just ended. During the discussion, President Sebastian Migdalski revealed some key insights regarding penalties imposed in Poland by the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (URPL, WMiPB).
The new information can be summarized in three points:
This is an important signal for the industry in Poland: while penalties remain moderate for now, URPL is closely monitoring the market and prioritizing real risks to patients and transparency of communication. Unfortunately, despite assurances that formal breaches are the lowest priority, in our practice we most often encounter allegations related precisely to violations of formal requirements in advertising.
