Directives on active implantable medical devices (90/385/EEC)

Impact of the MDR on Quality Management Systems (QMS), technical documentation, clinical trial requirements, UDI and combination products.

The Commission adopted a package of measures on innovation in health. The package consisted of a Communication and two regulation proposals to revise existing legislation on general medical devices and in vitro diagnostic medical devices. In particular, the Directives on active implantable medical devices (90/385/EEC) and on medical devices (93/42/EEC) are intended to be replaced by a Regulation on medical devices, while the Directive on in-vitro diagnostic medical devices (98/79/EC) is intended to be replaced by a Regulation on the same subject.

Medical device Regulation

The revisions therefore affected all kinds of medical devices including in vitro diagnostic medical devices, from home-use items like sticking plasters, pregnancy tests and contact lenses, to X-ray machines, pacemakers, breast implants, hip replacements and HIV blood tests.

This Seminar will look at what to expect when the new regulation is implemented. Including: the transition period, Effect on Notified Bodies, Impact of the MDR on Quality Management Systems (QMS), technical documentation, clinical trial requirements, UDI and combination products.

  • The updated Regulation
  • Implementation dates and transition
  • Main changes and products affected
  • Effect on medical device manufacturers

Salma Michor , PhD, MSc, MBA, CMgr, RAC is founder and CEO of Michor Consulting Schweiz GmbH, serving such clients as Johnson & Johnson, Novartis, Shire, Pfizer and Colgate Palmolive. Previously, Michor worked for Chiesi-Torrex, Wyeth Whitehall Export Croma Pharma GmbH. She teaches regulatory affairs and clinical strategies at the University of Krems, Austria, and is an independent expert to the European Commission. She holds a PhD in thermal process engineering and an MSc in food and biotechnology from the University of Applied Life Sciences in Vienna, Austria; an MSc from King’s College, University of London in food technology; and an MBA from Open University, and has earned the RAC (EU), CQA and is a Chartered manager.

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.


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.”

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 . 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.

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:

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Why is a supplier audit program necessary?

Why is a supplier audit program necessary?

A supplier audit program is a must-have in medical devices and pharmaceutical manufacturers, especially those that outsource their processes. Being such an important element in the supply chain; a supplier audit program is the driving force towards ensuring quality and consistency in the supply chain, and is a very important component of the quality.

Expect to carry out a supplier audit program for these reasons

That a supplier audit program is certainly required is a given. If you are a manufacturer, why do you need a supplier audit program and what should you look out for? It is the manufacturer who has to undertake a supplier audit program because the FDA has NO regulatory requirement for a supplier audit. So, it is up to the manufacturer to ensure that he carries out a supplier audit program himself.

A supplier audit program could become necessary for these reasons or situations:

Initial: Things to consider could include whether you should pay a visit to the supplier at the start of the contract. Or do you make visits at regular intervals? How much time to you spend at the supplier’s facility?

Instances of noncompliance: At some point of time, you could come across a supplier who has failed to deliver to requirements. When say, the first shipment is not up to requirements, how do you tackle the issue?

History: It is possible that the supplier has consistently delivered negative results. If you have had a bad history of working with a supplier, what do you do? How do you haul him up? How do you correct the issue?

Criticality of the product or service: This could be another reason for which the manufacturer will need to carry out a supplier audit program.


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