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Europe Readies for Big .pdf



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Related Articles: 2
This copy is for your personal, non-commercial use. For high-quality copies or
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Printed by Mr. Norm Rabin, Maetrics LLC

Europe Readies For Big Changes In
Device Postmarket Surveillance

EU Policy-Makers Set End-OfYear Goal To Finalize Device, Dx
Reform
“The Gray Sheet” Oct. 15, 2015
EU Device Reform Proposal
Adds More Government
Scrutiny, But No FDA-Like
Review Body
“The Gray Sheet” Oct. 1, 2012

By Amanda Maxwell / Email the Author
Features & Analysis / Word Count: 1126 / Article # 01160201005 / Posted:
January 28 2016 6:00 PM

Topics Covered in
this Article

Executive Summary

Click a keyword for related
articles.

Europe may be on the cusp of a big drive toward a more clearly organized
and more transparent postmarket vigilance system with new funds directed at
the issue in the wake of device safety scandals. The European Commission
recently launched the second phase of its joint action plan of near-term
device and diagnostics reforms, pushing postmarket surveillance to the top
of its agenda.

General Topics
surveillance
SilverSheet

Efforts to strengthen postmarket surveillance activities in the European Union are
picking up steam as the region tries to address gaps identified in the wake of device
product scandals in the region.

Industries
Medical Devices
In Vitro Diagnostics

News is expected in the coming months on which medical device projects will be
targeted with $925,000 in EU funding focused on market surveillance activities.

Subjects
Regulatory
Post-Market Regulation
Product Safety

Regions
Europe

Applications for these projects were submitted last October, but details of the
submissions have yet to be released.
The 2011/2012 Poly Implant Prothèse (PIP) affair, where a French manufacturer
fraudulently sold breast implants with industrial-grade silicone, pressed policymakers to try strengthen coordination of postmarket surveillance of devices among
EU member-state competent authorities as part of broader reforms. (See "EU
Device Reform Proposal Adds More Government Scrutiny, But No FDA-Like
Review Body" — "The Gray Sheet," Oct. 1, 2012.) In early 2015, market
surveillance was singled out and pushed to the top of the EU agenda when the
European Commission publicized the second phase of its joint action plan.

https://www.pharmamedtechbi.com/publications/the-gray-sheet/42/5/europe-readies-for-bi... 1/29/2016

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Research prompted by the PIP affair has highlighted significant weaknesses and
anomalies in EU device surveillance. (See sidebar.) As a result, Europe may be on
the cusp of a big drive toward a more clearly organized and more transparent
vigilance system.

Notified Bodies Were Hit
Hard: Manufacturers Next?
To understand the potential impact on
medical device and in vitro diagnostic
manufacturers of the EU's enhanced
focus on market surveillance, one can
look at the outcomes of the first phase of
the European Commission’s joint action
plan, which was mainly focused on
raising standards among notified bodies,
which are the third-party groups that
companies contract with to fulfill EU
standards.
The first-phase effort resulted in the
drafting of two documents in 2013, some
18 months after the joint action plan was
launched – the Implementing Regulation
on the designation and supervision of
notified bodies by designating authorities,
and a recommendation on how notified
bodies conduct audits.

Market Surveillance Mess?
EU device market surveillance is
diverging widely in terms of
practice, intensity of surveillance,
targets of controls, types of
measures taken and resources
available, according to a June
2014 European Commission Staff
Working Document on the
Implementation of the Joint Plan for
Immediate Actions under the
existing Medical Devices
legislation. The report highlighted
differences concerning the types of
products and the items checked,
the reasons triggering checks, and
the measures taken.
See sidebar at end of article

These documents have had a major
impact on how medical devices are regulated in Europe. The way notified bodies
operate will never be the same again
. So can we expect an equally powerful set
of measures in the market surveillance area?
So far, the United Kingdom has been instrumental in developing the proposal for
of the Competent Authorities
the project via its leadership of the executive group
Medical Devices (CAMD) network and its involvement in the EU Compliance and
Enforcement Network (COEN).
Indeed, progress in improving market surveillance by competent authorities has
been a primary focus of the CAMD group in efforts to optimize the management of
the European Commission’s working group resources.
In February 2015, CAMD announced that a subgroup of its executive committee
was tasked to work with the commission to create an outline map of market
surveillance activities and proposals.
Ultimately, separate working groups will examine whether the current EU oversight
architecture is appropriate and establish next steps, CAMD said. The working
groups will also be tasked with assessing the role of the COEN group.

COEN’s Role

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Early in 2015, COEN, made up of competent authority representatives, had already
submitted a proposal to develop a joint action plan for market surveillance. This joint
action is now up and running and involves a review of the quality of instructions-foruse for reusable surgical instruments in particular. The effort was awarded about
$227,000 in funding from the commission.
While the project is mostly focused on reusable surgical instruments labeling, it will
include efforts to pilot new infrastructure and processes to enhance collaboration
between member authorities.
COEN, however, has previously struggled to launch joint market surveillance
projects between EU competent authorities. According to the European
Commission, a major pilot project finalized in the summer of 2013 “had limited
success with only 10 member-states responding to the call, six of which were finally
able to provide full reports on the outcome of the project on a national level." There
were challenges in reaching agreement on project selection and sharing and
distribution of the workload. Complications also surfaced relating to translation,
confidentiality and follow-up measures.

Proposal To Expand Initiative
The CAMD network is now looking to broaden the focus of the joint action plan to
longer-term development of a collaborative market surveillance system.
John Wilkinson, head of devices of the UK's Medicines and Healthcare products
Regulatory Agency (MHRA), told "Gray Sheet" sister publication Clinica that the
CAMD executive committee, which he chairs, is preparing a second, much larger
submission seeking some of the additional funding now being offered by the EU.
It would be necessary to have “a fairly detailed program on the table by the end of
the year … as well as sufficient commitment from enough member-states to make it
happen – largely in terms of time and energy,” Wilkinson explained in an interview
last June
.
The goal is to create a rolling program of
The European
activities, which will help address the
Commission’s Compliance
need for more intense activity in market
surveillance, a responsibility which every
and Enforcement working
member-state finds difficult to adequately
group, whose main remit is
manage, Wilkinson said. The UK
market surveillance, is
regulatory official expressed interest in a
developing a "step-by-step"
model established by Prosafe – Product
manual for member-states
Safety Forum of Europe
– a nonprofit
on market surveillance.
organization with a focus on market
surveillance authorities and officers. They
are active in the area of horizontal
consumer protection legislation and effectively run a “well-oiled” cooperative,
Wilkinson said.
In parallel, the European Commission’s Compliance and Enforcement working
group, whose main remit is market surveillance, is developing a "step-by-step
manual" for member-states on market surveillance
.

https://www.pharmamedtechbi.com/publications/the-gray-sheet/42/5/europe-readies-for-bi... 1/29/2016

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Also, there are several EU-coordinated market surveillance activities that have been
launched with a focus on specific device types. For example, two market
surveillance projects are listed by ANSM, the French regulator for health care
products, in its 2016 work program
: one focused on syringes and needles; the
other on hyaluronic acid used as a filler in cosmetic surgery.
These developments proceed as the European Commission is working with the two
EU legislative bodies to establish regulations with broad-based structural reforms
for oversight of devices and IVDs. The ongoing work by CAMD and COEN
anticipates the changes envisioned in those legislative reforms. (See "EU PolicyMakers Set End-Of-Year Goal To Finalize Device, Dx Reform" — "The Gray Sheet,"
Oct. 15, 2015.) But to what extent the ongoing market surveillance projects will
impact the final texts of the Medical Device and IVD Regulations, which are
anticipated to be adopted in June, remains to be seen.
• A version of the article appeared in Clinica

.

This copy is for your personal, non-commercial use. For high-quality copies or
electronic reprints for distribution to colleagues or customers, click here or call
+1 (908) 547-2200.
Printed by Mr. Norm Rabin, Maetrics LLC

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Market Surveillance Mess?
EU device market surveillance is diverging widely in terms of practice, intensity of surveillance, targets of controls,
types of measures taken and resources available, according to a June 2014 European Commission Staff Working
Document on the Implementation of the Joint Plan for Immediate Actions under the existing Medical Devices
legislation
.
The report highlighted differences concerning the types of products and the items checked, the reasons triggering
checks, and the measures taken.
Some countries focus exclusively on products of manufacturers or authorized representatives registered on their
territory. Some countries consider the control at the occasion of the registration of the products into national registries
as a formal market surveillance check, the report stated.
Several EU member-states focus on labeling and packaging, while others examine all possible fields of
nonconformity. Some countries decide on priorities for surveillance taking vigilance data into account, among other
elements, but for others vigilance data are almost the exclusive basis. Some cooperate closely with customs, but
most do not.

https://www.pharmamedtechbi.com/publications/the-gray-sheet/42/5/europe-readies-for-bi... 1/29/2016

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Many of the member-states recognized, according to the commission report, that because of a shortage of resources,
market surveillance is only reactive and that no proactive surveillance is carried out.
The report contains a request to member-states, "to reinforce their market surveillance which should include
appropriate checks on the characteristics of products on an adequate scale, by means of documentary checks and,
where appropriate, physical and laboratory checks on the basis of adequate samples and, when necessary and
justified, visit the premises of economic operators and take the necessary samples of products."

https://www.pharmamedtechbi.com/publications/the-gray-sheet/42/5/europe-readies-for-bi... 1/29/2016


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