Advocate General Opinion on Software Medical Devices

On 28 June 2017, Advocate General Sanchez-Bordona (AG) presented his opinion in case C-329/16 Syndicat national de l’industrie des technologies médicales and Philips France following a request for preliminary ruling from the Conseil d’État (France) to the Court of Justice of the European Union (CJEU) concerning the laws governing the classification of software medical devices.

The AG’s opinion is not binding on the CJEU, but it provides useful guidance on the application of the EU medical devices Directive 93/42/EEC (the MDD) to software programs.  Importantly, it confirms the position set out in the Commission’s MEDDEV 2.1/6 guidance that software which merely stores and archives data is not a medical device; the software must perform an action on data (i.e., it must interpret and/or change the data).

EU national courts use the preliminary ruling procedure if they are in doubt about the interpretation or validity of an EU law. In such cases, they may ask the CJEU for advice. The Advocate Generals provide the CJEU with public and impartial opinions to assist the Court in its decision making. The Advocate Generals’ opinions are advisory and non-binding, but they are nonetheless influential.  In the majority of cases the CJEU follows the Advocate General.

Background

Philips France (Philips) manufactures and places on the EU market a software program called Intellispace Critical Care and Anesthesia (ICCA), which is used by physicians to provide information necessary for the proper administration of medicines for the purposes of resuscitation and anaesthesia.  The software highlights possible contraindications, interactions with other medicines and excessive dosing.  Philips classified the ICCA as a medical device under the MDD and the product bears a CE mark confirming that the software complies with the applicable requirements of the MDD.

Under French law, software programs intended to support medical prescriptions are subject to national certification requirements.  The French Government’s position is that the ICCA must comply with this national certification requirement. Further, it does not consider the ICCA to be a medical device within the meaning of Article 1(2)(a) of the MDD because the function of assisting with prescriptions does not fall under any of the defined purposes within the definition of a medical device.

Philips claimed that the national certification requirement should not apply as it amounted to a restriction on import, contrary to EU law, and that the French Government was in breach of Article 4(1) of the MDD, which provides that Member States must not restrict the placing on the market or the putting into service of medical devices bearing the CE mark within their territory.

The French Conseil d’État referred to the CJEU a request for a preliminary ruling on the question of whether software equivalent to the ICCA satisfies the definition of a medical device under the MDD.

AG Opinion

The AG opinion suggests that Philips had correctly classified the ICCA as a medical device.  It highlights that since the ICCA bears a CE mark and is freely marketed in 17 EU Member States, it benefits from a presumption of conformity with the MDD.  It was a matter for the French Government to rebut this presumption, and it had failed to do so.

In reaching his conclusion, the AG highlighted a number of points, including:

  • In order to qualify as a medical device, software must have a function beyond collection and archiving of data (i.e., it must have more than a purely administrative function). Rather, it must modify or interpret the data.  The ICCA software includes an engine that allows healthcare professionals to calculate the prescription of medications and the duration of treatments.  In light of such functions, the AG considers it difficult to maintain that the ICCA does not have a diagnostic or therapeutic purpose within the scope of the definition of a medical device. The ICCA is not a software program that is limited to administrative functions, but rather software that helps determine the proper prescription for the patient.  It is therefore a medical device as it has the aim of “preventing, controlling, treating or alleviating a disease”.
  • The fact that the ICCA does not act by itself in or on the human body does not preclude it from classification as a medical device. Contributing to the principal action of correcting the human body through the taking of medicinal products is sufficient.

The above conclusion endorses the position set out in the Commission MEDDEV 2.1/6 guidance on qualification and classification of standalone software, which states:

“…if the software does not perform an action on data, or performs an action limited to storage, archival, communication, ‘simple search’ or lossless compression (i.e. using a compression procedure that allows the exact reconstruction of the original data) it is not a medical device.”

Validation of Pharmaceutical Water Systems

validation-of-pharmaceutical-water-systems1

Thorough and proper validation of pharmaceutical water systems is highly essential for ensuring that the pharmaceutical unit uses the right quality of water. This is very important, because water is not only the source of life for humans; it enjoys the same importance in pharmaceuticals.

A very important reason for which validation of pharmaceutical water systems is necessary is that water is not only the most widely used raw material or substance in pharmaceuticals; it is also put to a number of uses in the pharmaceutical industry, such as Quality Control, process, production and formulation. Further, water comes with its own set of unique chemical properties that are obtained because of the hydrogen bonds present in it and its polarity. This makes water versatile, since it allows the dissolution, absorption, adsorption or suspension of various different compounds.

Process for pharmaceutical water systems validationvalidation-of-pharmaceutical-water-systems

Validation of pharmaceutical water systems is carried out in three phases:

Phase I, which is the investigational phase

Phase II, the short term control phase, and

Phase III, which is the long-term control phase

Pharmaceutical water systems are validated through these three steps or stages to demonstrate and ensure that the facility using pharmaceutical water systems has water under its control and is on the right track for production of the right quality and quantity of water in the short, medium and long terms.

Validation through commissioning and qualificationPharmaceutical water systems validation is carried out through two important steps, namely commissioning and qualification. Commissioning is about putting the validation of pharmaceutical water systems through the required phases using the prerequisite methods of documentation. This documentation is a core part of pharmaceutical water systems validation because it allows for different personnel in the organization to not only keep track of the processes involved, but also make changes when necessary.

Qualification as part of pharmaceutical water systems validationQualification is the next important stage of pharmaceutical water systems validation. Here, before a pharmaceutical water systems validation process is started, the pharmaceutical facility should implement the following important steps:

  • Design qualification (DQ)
  • Installation qualification (IQ) and
  • Operational qualification (OQ)

Phase I:In Phase I, the pharmaceuticals facility samples and tests water sampling for anywhere between two and four weeks for monitoring the water system. If the water system is free of failure during this phase, it is considered a successful phase of pharmaceutical water systems validation.

Phase II:In this phase of pharmaceutical water systems validation too, the water system sample is tested intensively for two to four weeks, during which the water sample should show that it is producing the right quantity of water under conditions of stated SOP.

Phase III:Phase III of pharmaceutical water systems validation is the longest and most arduous period, running to one year after completion of Phase I and Phase II. When the water sample passes through this phase, it is said to have completed the process of pharmaceutical water systems validation and is considered fit for pharmaceutical use.

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Compliance for medical devices is a very expansive area for manufacturers of medical devices

Compliance for medical devices is a very broad and vast topic. When one talks of compliance for medical devices, one needs to keep in mind the various regulations that the FDA has put in place for manufacturers of medical devices to comply with. The FDA requires strict compliance with its laws and requirements because it is charged with the task of ensuring the quality requirements of medical devices, which are a means to ensuring that the medical devices are safe and effective.

The FDA has undertaken the task of ensuring that medical devices, along with select nonmedical devices adhere to regulations pertaining to manufacturing; repackaging, relabeling and/or importing medical devices sold in the US comply with its requirements through its Center for Devices and Radiological Health (CDRH). The requirements for compliance for Class I, II and III medical devices, such as the registration of the establishment, listing of the medical device, 510 (k), premarket approval investigational device exemption (IDE), Quality Systems, GMP, device labeling and device reporting are set out in the various sections of 21 CFR Part 807.

A GlobalCompliancePanel seminar which will cover all the important areas of compliance for medical devices

A seminar that is being organized by GlobalCompliancePanel, a highly reputable provider of professional trainings for the areas of regulatory compliance, will be delving into the details of all that is required for compliance for medical devices. A boot camp of sorts, this seminar, which will cover all the important areas of compliance for medical devices, will have Susanne Manz, Quality and Compliance Expert / Auditor for Medical Devices, Manz Consulting, Inc. as the speaker.

To enroll for this very valuable seminar, just log on to http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900834SEMINAR?compliance-boot-camp-Phoenix-AZ . This seminar on compliance for medical devices has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.

A boot camp to ensure compliance for medical devices

Susanne will help participants from the medical devices industry get a thorough idea of what it takes to ensure compliance for medical devices. She will show ways by which to improve the quality and compliance of medical devices, while at the same time, optimizing costs. This boot camp is a means to building a sound Quality System with which to ensure compliance for medical devices.

An important piece of learning that Susanne will bring into this seminar is how to understand regulatory requirements and translate them into an effective and efficient Quality System. The ways of planning, structuring, and implementing a Quality System that addresses the specific business needs of the participants will be addressed at this seminar.

Means to address issues within a medical device company’s Quality System

In discussing how to create a quality strategy and plans; Susanne will explain some of the methods that need to be put in place for identifying, prioritizing and analyzing risks. She will help explore the capabilities that every medical device company needs to have if it has to ensure quality products and a compliant Quality System.

In this seminar on compliance for medical devices, Susanne will also take up important related items such as continuous improvement, Six Sigma, and Corrective and Preventive Action (CAPA) to address issues within a medical device company’s Quality System. The ways of effectively communicating and escalating risk, as well as monitoring performance and progress, as well as how to kick start the Quality System into avoiding common problems such as MDRs, recalls, 483s, and Warning Letters, will all be covered in this seminar on compliance for medical devices.

Susanne will cover the following areas at this seminar:

o  Quality System Expectations

o  Quality System Structure

o  Strategy and Planning

o  Risk management in your quality system

o  Case for Quality

o  Inspection preparedness and management

o  Monitoring and metrics

o  Creating a quality strategy and plans.

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/MedicalDeviceQualityandCompliance/default.htm

Regulatory Filing Requirements for medical devices in Japan

 

Japan is the world’s third largest market for medical devices, after the US and Europe. Ironically, many of the world’s medical device manufacturers find language barriers for communicating with Japanese regulatory authorities a greater barrier than passing through the regulatory maze! The regulatory filing requirements for medical devices in Japan are relatively less complex than those of the US and Europe and other markets.

Regulatory filing requirements for medical devices in Japan start with passing what is called the Pharmaceutical and Medical Device Law (PMDL). To facilitate better understanding of the language and to make regulatory filing requirements for medical devices in Japan easier, the Pharmaceuticals and Medical Devices Agency (PMDA), which is a part of the Ministry of Health, Labor and Welfare (MHLW) issues English language documents.

The “Toroku” registration processThe Japanese system for complying with regulatory filing requirements for medical devices has two different modes for domestic and foreign medical device manufacturers. For Japanese medical device companies, a registration system known as “Toroku”, which is formulated under the PMDL, applies. According to this process, domestic manufacturers whose manufacturing processes are based in Japan have to register their manufacturing facilities with the local authorities at their respective prefectures. For foreign manufacturers, the same have to be registered with the PMDA.

The step-by-step processThis is how the step-by-step process for regulatory filing requirements for medical devices in Japan takes place:

Read More

Medical device regulatory compliance training

For any professional in the medical devices industry; training is a must. This training has to be on the regulatory aspects of the industry profession, because this is at the root of the profession. Medical devices being one of the most regulated industries, a professional in this industry is governed by a slew of regulations.

Medical device regulatory compliance training is thus necessary to help them achieve two ideals: one, to enter the profession, and two, once they are part of the profession, to keep updating their skills and knowledge, since this an ever-changing field. New technologies and other developments warrant new regulations. So, medical device regulatory compliance training is essential for anyone in the profession to both start and to advance in it.

Who carries out medical device regulatory compliance training?

The FDA authorizes a few select certifying bodies to carry out medical device regulatory compliance training. It sets out the nature, as well as the other technicalities such as syllabus, duration of course, rewards system and so on. The authorized certifying body then runs the course that addresses the requirements of medical device professionals. Many of these certifying bodies carry out these designated, authorized trainings in a number of formats, which professionals can choose from based on their convenience and need.

What do these courses contain?

Being authorized courses, the medical device regulatory compliance training courses from authorized certifying bodies cover nearly all areas of compliance training for medical devices. There are a few core subjects as well as a few optional ones. Generally, although not necessarily, most courses consist of these training syllabi:

  • Overview of FDA Regulatory Compliance for Medical Devices
  • Design Control
  • Design Validation, Verification, and Risk Analysis
  • Medical Device Submissions – 510ks, PMAs, and Exemptions
  • Process Validation

In addition, professionals enrolling for medical device regulatory compliance training can choose from a range of electives. Typically, they are offered the option of choosing one among:

  • FDA Inspections
  • Post Market Surveillance and Complaint Handling Systems
  • EU Directives, Guidance, CE Marking and ISO Standards Certifications
  • Recalls, Product Recovery and Safety Alerts
  • Risk Management
  • European Regulatory Procedures
  • Auditing and Qualifying Suppliers and Vendors
  • Computer Systems Validation
  • Document Management
  • Quality Assurance Auditing for FDA Regulated Industries
  • Writing Standard Operating Procedures and Other Documents
  • The EU Clinical Trial Directive
  • Technical Writing for the relevant industries
  • Root Cause Analysis of Failures & Deviations – Developing CAPA Strategy

References:

http://www.cfpa.com/about-us/

http://www.cfpie.com/content.aspx?c=CMDCP

 

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FDA guidance

FDA guidance

AnFDA guidance, as the title suggests, is a set of suggestions from the FDA on a number of its governing areas. The FDA, being a regulatory body sets standards for almost every conceivable area. It is almost impossible to list the number of guidances the FDA has issued.

Nonbinding in nature

Guidances are suggestions for best practices and methods, and are not a set of rules. The outstanding characteristic of FDA guidances is that they are nonbinding. The FDA website states as much: “This guidance represents the Food and Drug Administration’s (FDA’s) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. If you want to discuss an alternative approach, contact the FDA staff responsible for implementing this guidance.”

This note is to be found in guidances the FDA issues in every of its governing areas. As can be seen from the above explanation; guidances are open to interpretation, and the individual, group of individuals, organizations or laboratories that come under these guidances are free to offer their own perspective. They can discuss industry-specific guidances with the FDA and sort out matters whenever disagreements arise.

General areas for FDA guidance

These are the broad areas in which the FDA has issued guidances:

  • Food
  • Drugs
  • Medical Devices
  • Vaccines, Blood & Biologics
  • Animal & Veterinary             Cosmetics
  • Radiation-Emitting Products
  • Regulatory
  • Tobacco Products

References:

http://www.fda.gov/regulatoryinformation/guidances/default.htm

http://google2.fda.gov/search?site=FDAgov-Guidance-All&restrictBox=FDAgov-Guidance-All&restrictBox=FDAgov-Guidance-Food&q=&btnG=Search&client=FDAgov&output=xml_no_dtd&proxystylesheet=FDAgov-Guidance&ie=UTF-8&oe=UTF-8

 

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IEC 60601-1 Third Edition –introduction and implementation dates

The IEC, which stands for International Electrotechnical Commission, dates its founding to more than a century back, to 1906. It is the world’s leading voluntary organization for regulation of the technologies that collectively go into electronic components and are bunched together as electrotechnology.

In setting standards for electronic and electrical gadgets, the IEC regulates, in effect, millions of electronic devices that go into the market. It has set out the IEC International Standards and Conformity Assessment Systems, ensuring compliance with which these devices work safely and effectively.

Medical Safety IEC 60601-1, 3rd Edition

The IEC 60601-1, 3rd Editionconcerns regulations for electronics that go into medical devices. These are the highlights of IEC 60601-1 standard, 3rd Edition:

More than 60 device standards are derived from this standard, thus making it the parent standard for these device standards. The third edition was issued in 2005, and has set the following mandatory adaption dates for compliance for these respective markets:

  • Europe: June 1, 2012
  • Canada: June 1, 2012
  • USA: July 1, 2013

Highlights

Medical device manufacturers in all these markets must conform to new revised guidelines within the deadlines prescribed for their respective markets. Apart from using risk management throughout, the other highlight of the newly revised IEC 60601-1, 3rd Editionstandard is that it is less prescriptive in many areas. It leaves many such areas for broader interpretation. Also, the new IEC 60601-1, 3rd Edition requires that all applicable collateral and particular standards must be used for compliance.

 References:

http://www.eisnersafety.com/safety_articles/product_safety/work_in_progress_iec_60601-1_medical/#.UDcQU6N21iA

http://www.gmcompliance.com/iec-60601-1/

 

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