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Association Of Indian Medical Device
Industry
EU plus Regulatory Report – March 2011
1 DEMISE OF THE GHTF
After years of trying to be heard the GHTF (Global
Harmonising Task Force) has been disbanded. They had lots of good ideas about
levelling the medical device regulatory playing field but national interests
have eventually won over! Simplications for India (?)
2 FINING COMPANIES WHEN THEY DON’T CONFORM
A UK company was fined as the CE marked transformer they
supplied with their product did not conform to EU standards. Although the
company had certification from their supplier (in China) they had not done any
further testing themselves. The conclusion to this could be that any company
that import parts, components, sub assemblies or products into the EU should
ensure that CE marks and / or certificates issued outside the EU are valid.
3 REVISION OF EU DEVICE LAW
The “recast” of the EU medical device regulation has started
in earnest with a finish date proposed for 2015. A first draft may be available
as early as June. It should be noted that this will probably be a “Regulation”,
as opposed to a “Directive”, this means that member states will not be able to
make subtle changes.
Field safety corrective actions will be important and closely
regulated. Impending changes are already on the way to make reporting electronic
(as it is in Germany now) and mandatory to undertake documented corrective
action following all field safety corrective action notifications.
Loads of documents are flying around, and it is difficult to
make sense of why the revision is being made. Some of the reasons given for the
revision are the need for;
A supportive regulatory framework as a key pillar for
innovation :
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Taking early account
of the needs of all stakeholders.
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User data from post
market experience (e.g. post-market clinical follow-up, European registers) to
feed clinical evidence for regulatory purposes (e.g. through continuous
assessment of safety and performance by Notified Bodies) and for reimbursement
purposes.
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Mechanism to allow
timely access to innovative technologies while gathering clinical evidence, e.g.
by means of "conditional CE marking" (concept of "orphan device" or "unmet
public health needs")
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The need for clear
and simple regulations, well defined requirements and responsibilities and
transparent decision-making processes.
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A central and
publicly available database providing information about manufacturers /
authorised representatives, medical devices, clinical investigations, field
safety corrective actions
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Use of modern IT
tools and Unique Device Identification (UDI) databank for traceability and
safety
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Central notification
of serious incidents, enhanced involvement of healthcare professionals in the
vigilance system, coordinated analysis, harmonised decisions and transparency
regarding field safety corrective actions
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The creation of a
Statutory Medical Device Committee composed of experts from Member States
(supported by specialist subgroups) with a clear mandate and well defined powers
4 EU AUTHORISED REPRESENTATIVE OR SAFETY OFFICER?
Many problematic issues are being talked about in the Medical
Device Directive recast, one being the expansion of the German equipment for a
“safety officer” to be available for all companies that sell medical devices
into the EU. The responsibilities may include the need to “verify” that
technical files exist for Class 1 devices.
The current German definition of the mandatory safety officer
is ;
(1) The person responsible (company in Germany) who has
his/her registered place of business in Germany shall, immediately upon
commencement of his/her activities, appoint a person who is sufficiently
reliable and possesses the expert knowledge necessary for the fulfillment of
his/her functions as the safety officer for medical devices.
(2) The person responsible shall notify the competent
authority immediately of the name of the safety officer as well as of any
changes thereto. The competent authority shall transmit the data referred to in
sentence 1 to the German Institute for Medical Documentation and Information (DIMDI)
for central processing.
(3) Proof of the necessary expert knowledge qualifying the
person in question for the post of safety officer shall be provided in the form
of: a certificate testifying to a completed course of natural science, medical
or technical university studies, or any other course of training which qualifies
said person to fulfill the tasks set forth under paragraph 4, as well as at
least two years' professional experience. Upon demand by the competent
authority, proof of the relevant expert knowledge shall be adduced.
(4) The safety officer for medical devices shall collect and
evaluate existing information concerning risks connected to medical devices and
shall co-ordinate the necessary measures. He/she is responsible for the
fulfillment of reporting obligations in so far as they concern risks related to
medical devices.
(5) The safety officer for medical devices shall suffer no
disadvantage by executing the tasks entrusted to him/her.
5 MEDICAL DEVICE DISTRIBUTION IN GERMANY.
It is known that the reimbursement system in Germany is
controlled by several healthcare insurance groups. These people have a big say
in the types of product used and their availability.
We understand that one of these big insurance companies is
insisting that the distribution centres are accredited to ISO 9001, or even EN
13485.
We are not too sure how prevalent this is at the moment but
if you are distributing in Germany you may like to check the distribution
company you use.
6 BE HONEST IN YOUR POST MARKET SURVEILLANCE!
The British Orthopedic Association, and the British Hip
Society, said in a recent statement that data on certain hip implants from four
surgeons indicated that the rate of second operations, or revisions, ranges from
21 percent after four years to 49 percent after six years.
But DePuy, recalled its ASR devices globally after referring
to other public data showing that, within five years, only 12% of recipients of
the hip resurfacing system and about 13% of recipients of the acetabular system
needed corrective surgery.
Who’s data is correct, what were DePuy working to? Was this
an error in post market surveillance gathering? Were figures made to look less
that they were?
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