Is EU more competitive than US for medical devices?

The American landscape US-FDA device classification
The US-FDA classifies devices according to the level of risk associated with a device in case of a probable malfunction into classes I,II and III  (FDA, 2014).

Extensive study results needed to place medical device in US market

• There are detailed documents and regulations describing the level of clinical trial testing needed for the different classes of devices before they are placed on the market
• These increase progressively with the level of risk associated with the device needless to say increased safety
• The details of the study protocol and the results observed including adverse reactions are to be submitted as evidences along with the “Pre-market Approval” (PMA) application to the     FDA

Conduct of clinical trials for USFDA
US-FDA may be considered as the more transparent regulatory agency as there is a publicly accessible database, maintained by the US-FDA containing

• Clinical trials in different stagesin medical devices
• Classification of medical devices
• Medical devices for which pre marketing approval (PMA) has been granted with details of PMA order
• Status of any post-approval studies (PAS) being carried out
• Labelling and other information that would be made available to the end user of the device

The European landscape EU device classification
In the EU medical devices are classified based  on  mode of action such as a medical device, implantable medical device, active implantable medical device and in vitro diagnostic devices . There are 18 classification rules that are applied to put devices into either of the classes I, IIa, IIb, and III such as whether the device is a invasive or not, if it is introduced by one of body’s orifices or surgically, if the device is used to simply absorb body’s exudates or modify properties of bodily fluids and duration of use or exposure (Rheinland T).

Placing  medical device in EU market vs US market
In obtaining a marketing authorisation for a medical device in the EU, any study conducted should provide proof that the device satisfies the manufacturer’s benchmark for effectiveness and safety via the clinical evaluation route or the clinical investigation route. Whereas, in the US study results need to demonstrate patient satisfaction in disease alleviation. This is said to considerably increase the duration, complexity and the number of participants in the clinical study in the US when compared to the EU.The relatively lesser amount of testing needed in the EU also means that these medicinal products reach the market faster and are available to the patient faster.

Authorisation for sale and use of medical devices in the EU is usually made in the form of “conformity assessments”. While standardisation certifications like the ISO are recommended for medical devices in the EU, they are not an absolute requirement as per the gazette.

Generally in the EU, depending on the operational complexity of the medical device in question, either the manufacturers themselves or independent firms called “notified bodies” carry out safety and quality assurance assessments on the manufacturing sites and/or products to judge adherence to lot of regulatory guidelines. Upon conforming to the rules, the “CE” mark is affixed and the device is released into the market. For active implantable medical devices, clinical study is a mandatory requirement.

Manufacturers approach these notified bodies (third parties) that design the experiments, run them and collect data using methods conforming to stipulated standards laid down by regulatory authorities. The ability to produce air-tight evidence and results that guarantee regulatory approval optimised for time and cost of the overall process is the unique selling point (USP) of these notified bodies and hence the clinical studies are carried out according to proprietary methods. While the details of these studies carried out and their results are made publicly available neither by the notified bodies nor the regulatory agencies, certain pharmaceutical companies have started creating and maintaining databases for their products alone on their company website. As is the case with other medicinal products, routes of obtaining marketing authorisation include the centralised, decentralised and mutual recognition procedures (COMMISSION, 2015b).

While EU regulatory agencies have not come out with mandatory regulations with respect to the type of testing and data to be collected, a large body of guidelines are available for different stake holders in the process such as manufacturers, investigators, researchers, ethics committees and notified bodies.

The requirement of a “pre-market approval” (PMA) before marketing medical devices in the US makes sure there is a third party (the regulatory authority) that goes through each and every detail that supports the safety and effectiveness of the device before it is released into the market. PMA is granted to the applicant with instructions on the periodic safety updates and studies that need to be carried out to further characterise the safety and efficacy profile of the device. In the EU all responsibility lies with the manufacturer in ensuring the safety of the end user. In the EU, it is the practise for manufacturers to voluntarily send out “Field Safety Notices” (FSN) to the regulatory authority, health care professionals (HCP) and patients about any breakdown in safety when using the medical device. While data used to arrive at the following figure was obtained from a database of field safety notices on the MHRA website, almost all of them were voluntary recalls with the website explicitly stating that, “the database is presented for information purposes only” and that HCPs should follow direct communications from the manufacturers.

Voluntary medical device & related product recalls
Figure 1 is a graphical representation of the distribution of voluntary medical device product recalls based on field safety notices issued via the Medicines and Healthcare Products Regulatory Authority (MHRA) in 2014 (MHRA, 2014).

The majority of recalls (about 55per cent) were found to be associated with medical devices such as syringes, blood glucose meters, external defibrillators, insulin infusion pumps and mobilisation support devices. Another important category (about eight per cent) concerns the implantable cardioverter defibrillators and pacemakers with safety concerns as fundamental as failing batteries or improper indication thereof. All of these are used in large volumes and under emergency situations on a day to day basis where, a malfunction could quickly escalate to be life threatening.

A European Commission memo document states that, “The Commission proposals will be discussed in the European Parliament and in the Council. They are expected to be adopted in 2014 and would then gradually come into effect from 2015 to 2019” (Commission, 2012).

Conclusion
Analysis shows that the US has more stringent regulations with explicitly detailed guidelines specifically for medical devices relating to their classification and the level of evidence required to establish safety, efficacy and effectiveness including their follow-up to ensure continued safety of the general public. This is generally felt to increase the cost and practical difficulties in bringing a new product to the market. However, it also remains the more transparent regulatory system.

For start-up companies, involved in the design and manufacture of novel medical devices, the grant of regulatory approval to launch their first product on to the market is seen as an important milestone in determining the success and life of the company. The relatively simpler guidelines in effect to this day in the EU have resulted in a number of start-ups entering the EU market first. It has also resulted in generally making available new medicinal products faster to the end user. But incidences in the EU that bear testimony to the negatives of having a relatively less stringent regulatory set up has led to the revamping of the EU guidelines which is supposedly in its final stages.The legislative measures are still in discussion (i.e., “Debate in Council”in the European Parliament as of December 2014) with difference of opinion between parties regarding the levels of pre-market scrutiny required for medical devices  (Commission, 2015a).