Tag Archives: medical device

What the Implant Files Are Not Telling

The investigation.  The “Implant Files” is a global investigation carried out by reporters in 36 countries under the lead of the International Consortium of Investigative Journalists (https://www.icij.org/investigations/implant-files/). The project, which attracted significant worldwide attention over the last few weeks as articles and reports were published, purported to show how the medical device industry failed to place on the market safe products and ultimately harmed a significant number patients.

Regrettably the way the investigation has been reported by several media outlets and the conspiracy theories underlying certain articles leave the readers without a clear understanding of the issues on the table and the policies behind the current regulatory framework.

The approval process.  For instance,  while the investigation was conducted globally, many articles published by European consortium members focused their attention on the lack of a centralized authorization procedure for the marketing of medical devices in the EU and argued that a loose regulatory framework enabled manufacturers to sell unsafe devices on the European market.

The absence of a centralized marketing authorization procedure for medical devices in Europe is depicted as a failure of European lawmakers, influenced by the medical device lobby. However, none of the articles reporting on the investigation provides readers – who may not be familiar with the authorization process – a clear and complete picture of the rationale and public healthcare policies behind the current regulatory framework. Most notably, the Implant Files investigation fails to explain the benefits for patients of a faster launch of innovative devices on the market. Neither they show any meaningful and documented difference in terms of patient safety between the EU and the US, where a centralized authorization procedure administered by the FDA is in force. The fact that the investigation concerns the US as much as the rest of the world is probably a good indication that the type of approval procedure does not per se guarantee patients’ safety and an effective healthcare system.

The new regulation.  As to the timing of the investigation, it comes at a moment of transition when the new EU medical device regulation has already been enacted but has not yet begun to unfold its innovative potential in the industry.  Yet, the Implant Files investigation seems to assume that the new regulation will have no impact on the industry and the approval/vigilance system as a whole. The investigation does not really delve into the changes and improvements brought by the new regulation, which has in fact already addressed many of the issues raised by the Implant Files. Among such innovations, new and improved vigilance measures and an increased accountability for notified bodies should be certainly taken into consideration.

Further, the investigation neglects the public discussions and exchanges that occurred throughout the EU (and the world) in the years that preceded the enactment of the new regulation, when the truth is that its provisions have been at the center of the public healthcare discourse for years, have been debated among experts, stakeholders and lawmakers in full transparency, have been reported by newspapers and specialized media. The alleged “scoop” seems a few years late.

The current vigilance system.  Lastly, one of the major flaws of many articles reporting on the investigation is that they give readers the idea that no meaningful vigilance system exists today. This is of course not correct. Italy, for instance, has a long-standing nation-wide register of approved medical devices marketed in its territory kept by the Ministry of Health. The same Ministry transparently shows on its website all safety notices and field actions carried out in Italy. The tool is easily searchable and can be found on the very first page of the medical device directorate’s site. 

Not only the Implant Files investigation failed to accurately report the existing vigilance and transparency measures, but created their own medical device database, allegedly aimed at providing the public with full access to data submitted by patients and reporters. 

Does the Implant Files investigation really benefit patients?  At the moment one cannot but wonder if this project really does provide patients with complete, accurate and independent information that can be useful for their health and wellbeing.

Is a public database, entirely managed by a private consortium, really empowering patients? How the database is managed, how the uploaded information is vetted and updated, for which purposes the uploaded information can be used by patients? Shouldn’t we work on improving a public, transparent system, managed by officers and professionals who have the scientific and regulatory expertise that is needed to address all issues involved, rather than building on a new, uncontrolled and unaccountable tool that could potentially distort patients’ behavior? The media would do a better service to the public opinion by giving a balanced, informative and articulate picture of the facts, rather than spreading sensationalistic news that would make anyone with an implanted device panic (and click on the article!).

 

Take our Quiz on the New MoH Guidelines on Medical Device Advertisement!

On December 20, 2017, the Italian Ministry of Health has issued interesting guidelines on medical device advertisement to the general public, which you can download here (scroll to the bottom of the page).

The new rules describe DOs and DONTs in advertisement on Instagram, YouTube and Facebook and offer interesting indications on the use of a celebrity in the ads.

The basic principle remains the same: advertisement of medical devices that are subject to medical prescription (or may be used only with the assistance of medical personnel) is prohibited by Italian law. When allowed, advertisement of medical devices to the public is subject to authorization by the Ministry of Health.

Take our medical device advertisement quiz to check if you know (or can guess!) what’s new in the guidelines!

  • Can a doctor recommend a medical device in an advertisement to the general public?

No, the Ministry of Health will not authorize such advertisement.

  • What about a celebrity appearing in an advertisement message?

While the mere presence of such individual may be tolerated, no express or implied endorsement of the medical device will be authorized.

  • Can authorized medical advertisement be shared through Instagram?

Yes, but only in the “Stories” section and if users’ comments are de-activated.

  • What about Facebook?

As comments cannot be de-activated, a special disclaimer must be used in order to clarify that the Ministry of Health authorization of advertisement solely covers advertisement, while any further comments are the responsibility of users.

  • Is a medical device company allowed to email advertisement to patients?

Yes, but only if the Ministry of Health has authorized the advertisement and if the patient has expressed his/her consent (always revocable).

Medical Apps and the Law Part I – What is a medical app? Perhaps it is a medical device. Find out!

Technology often starts in a simple way, perhaps with a simple “click” on an “I AGREE” button on your smartphone. Once the technology has spread, lawyers and authorities start debating what it is and how it fits with the laws.

The following post is the first part of a legal analysis of medical apps attempting to establish what they are under current legislation (Part I), as well as what is wrong with them according to various authorities who have scrutinized them (Part II).

 I keep reading and hearing that apps are not regulated and that the European Union stands behind than the United States in that process. Both statements are wrong. Medical apps can be regulated, if they fall within the scope of the definition of “medical device”. The trick is to find out if they do…

It probably takes less time to download a medical app on your smartphone than to determine if it falls under the definition of “medical device”[1]. Where to look for guidance?

THE EU COMMISSION GUIDELINES. In June 2012 the European Commission has issued Guidelines (MEDDEV 2.1/6) in order to attempt to clarify when standalone software is a medical device. A 6-step decision diagram is also provided by the Guidelines as an aid to decide if a medical application is a medical device. If the medical app is indeed a medical device, then a conformity assessment is required and the app must carry the CE marking.

One key element stands out in order to decide whether a medical app is a medical device: its intended use. This has been further emphasized in the Brain Products GmbH case (Case C-219/11) decided by the European Court of Justice regarding an electro-technical system enabling human brain activity to be recorded. The Court stated that “a device used in humans for the investigation of a physiological process falls within the scope of Directive 93/42 only if the intended purpose of that device, defined by its manufacturer, is medical”, while specifying that the fact that the software is used in a medical context is not sufficient to trigger its qualification as “medical device”. Therefore, the intended use of a device is up to the manufacturer, although – as the influential medical device counsel and blogger Erik Vollebregt puts it – “you cannot disclaim an obvious intended purpose as this would amount to a contradictory label and consequently a non-compliant product”.

THE FDA’s VIEW. On September 23, 2013 the United States Food and Drug Administration tackled the same problem and issued a guidance documentto clarify the subset of mobile apps to which the FDA intends to apply its authority”, because while “The FDA encourages the development of mobile medical apps that improve health care and provide consumers and health care professionals with valuable health information.”, however “The FDA also has a public health responsibility to oversee the safety and effectiveness of medical devices – including mobile medical apps.

FURTHER HELP FROM THE UK. On March 21, 2014, the United Kingdom Medicines and Healthcare Products Regulatory Agency (MHRA) has also issued guidelines to help “healthcare and medical software developers who are unsure of the regulatory requirements for CE marking stand-alone software as a medical device”. The MHRA indicated that software functions that, e.g., analyze, alarm, calculate, control, convert, diagnose, measure, monitor, are likely to lead the app to be considered as a medical device.

REALITY CHECK! The intention of the EU Commission, the FDA and the MHRA to clarify the regulatory framework is commendable and guidelines abound (see also the D4Research guide), but how many mobile medical apps actually bear a CE marking? How many app developers, app stores and app users are even aware of such requirements? I have witnessed awards granted to apps and eHealth projects which showed no awareness of the regulatory aspects. Announcements to “crack down” on illegal apps have been issued (e.g., by the Dutch authorities). What is happening in Italy? While the Ministry of Health is developing its own apps, its general manager Dr. Marletta in December 2013 has announced that the explosion of medical app use is an area of concern, especially with regard to risks and liabilities, which will be monitored by the authority going forward. Actual enforcement action, however, is still to be seen.

THE PROPOSED MEDICAL DEVICE REGULATION: WHAT MAY HAPPEN NEXT.  If the Proposal Regulation replacing the Medical Device Directive sees the light, software will be expressly regulated and specific quality requirements will apply concerning the following aspects:

  • software design must ensure repeatability, reliability and performance according to the intended use;
  • appropriate means to eliminate or reduce as far as possible and appropriate consequent risks in case of single fault condition;
  • software must be developed and manufactured according to the state of the art taking into account the principles of development life cycle, risk management, verification and validation;
  • if intended to be used in combination with mobile computing platforms, software must be designed and manufactured taking into account the specific features of the mobile platform (e.g. size and contrast ratio of the screen) and the external factors related to their use (varying environment as regards to level of light or noise).CONCLUSIONS. Medical apps do not stand in a regulatory vacuum: if they fall within the definition of “medical device”, they are subject to essential requirements and should bear the CE mark.
  • INSTRUCTIONS FOR USE FOR MEDICAL APPS: IN WHICH FORM? We note that, under the e-labeling regulation (Regulation no. 207/2012) entered into force on March 30, 2013, stand-alone software that is deemed to be a medical device can have instructions for use in electronic form, provided that the devices are intended for exclusive use by professional users and that the use by other persons is not reasonably foreseeable. Instead, if the app is a medical device but intended for a patient, instruction for use in paper form must be provided. This requirement appears both unpractical[2] and unreasonable given that a patient downloading an app seems “digital” enough to be sufficiently protected by electronic instructions.

[1] The very definition of medical device included in Directive 93/42/EEC, as amended by Directive 2007/47/EC, includes software. In fact, “’medical device’ means any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, together with any accessories, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application, intended by the manufacturer to be used for human beings for the purpose of:

  • diagnosis, prevention, monitoring, treatment or alleviation of disease;
  • diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap;
  • investigation, replacement or modification of the anatomy or of a physiological process,
  • control of conception,

and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means;”.

[2] An average smartphone user downloads 37 apps, according to the Opinion 02/2013 on apps on smart devices by the Article 29 Data Protection Working Party, page 2.