Consultation: Revision of the Medical Devices Directive and the In Vitro Diagnostic Devices

The EU is proposing updated regulations
on 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. The aim is to ensure these products are safe,
and can be freely and fairly traded throughout the EU.

Existing EU rules – dating back to the
1990s – have not kept pace with the enormous technological and scientific
progress in the past 20 years. Moreover different EU countries interpret and
implement the current rules in different ways.

KEY POINTS
PROPOSED FOR REVISION

The main changes being proposed at this
stage are:

  • It is not always possible to trace medical devices back
    to their supplier and therefore new rules on traceability are
    introduced – including provision of unique device identification (UDI).
  • Wider, clearer scope for EU legislation on medical
    devices – extended to include, for example, implants for aesthetic purposes,
    and clarified as regards genetic tests
  • Stronger supervision of independent assessment bodies
    by national authorities
  • More powers for assessment bodies to ensure thorough
    testing and regular checks on manufacturers, including unannounced factory
    inspections
  • Clearer rights & responsibilities for
    manufacturers, importers and distributors, which would also apply to diagnostic
    services and internet sales
  • Extended Eudamed database on medical devices – will
    provide comprehensive information on products available
    on the EU market. Non-confidential data will be publicly available
  • Better traceability of medical devices throughout the
    supply chain – enabling a swift and effective response to safety problems (e.g.
    recalls)
  • Stricter requirements for clinical evidence to support
    assessments of medical devices
  • Updated classification rules – dividing medical devices
    into 4 different risk categories and health & safety requirements,
    including labelling rules – to keep pace with technological and scientific
    progress
  • Better coordination between national surveillance
    authorities, with the Commission providing scientific, technical and logistic
    support
  • International guidelines to be incorporated into EU
    law.

 

 

 

WHO WILL BE
AFFECTED?

Manufacturers, Authorised
Representatives, Importers, Distributors and Users of medical devices.

WHAT PRODUCTS
WILL BE AFFECTED?

The following products fall under the
scope of the regulations:

  • Medical Devices – please refer to the text of the
    relevant draft;
  • In Vitro Diagnostic Devices – please refer to the text
    of the relevant draft;

 

 

DEADLINE FOR
FEEDBACK

Feedback or requests for clarifications
must be sent on by 30th November 2012.

Health and Safety Seminar


GRTU is holding a half-day seminar on health and
safety in your business. Everyday that passes new developments related to
health and safety come out and most of them are very important for you to know.
Most of these are binding by law and carry fines if not observed.

 

Incidents related to health and safety happen
frequently and carry a lot of repercussions to business. Knowing and caring is
in your business interest. Not knowing what is going on is not an excuse when
it comes to the law and GRTU is giving you this opportunity to become fully
informed and aware of your obligations. We will be discussing the following
issues:

 

–      
Introduction and updated information on 
Health and Safety

–       The
Health and Safety Authority

–       Main
responsibilities and duties of Employers and Self employed

–       Keeping
a safe and healthy environment – Practical tips

–       Being
assault ready – Consumer aggression and theft

 

 Wed 7th November 2012

14.30 –
16.30 (registration starts 14.00)

Excelsior
Hotel, Floriana

 

Seating is limited. Registration on 21 232 881/3 or

Nahdmu Flimkien biex nevitaw ir-Riskji


Il-ħaddiema huma l-esperti fix-xogħol
tagħhom u jafu bir-riskji li jiffaċċjaw ta' kuljum. L-koperazzjoni bejn
il-ħaddiema u l-maniġment hija essenzjali sabiex jiġu identifikati r-riskji fuq
il-post tax-xogħol u jittieħdu l-miżuri sabiex dawn jitnaqqsu jew jiġu
eliminati. Ghal hdax (11) l-sena konsekuttiva giet
organizzata l-OHS – Practice Awards 2012-2013, bis-suggett ta' din is-sena,
naħdmu flimkien biex nevitaw ir-riskji.

 

Fil-prattika, ħafna drabi ikun diffiċli
li r-riskji jiġu eliminati, iżda meta jsir sforz kollettiv ikun iktar faċli li
jinstabu soluzzjonijiet biex ir-riskji jitnaqqsu għal livell aċċettabli. Dejjem
jibqa l-obbligu ta' min iħaddem li jassigura li l-miżuri jiġu mplimentati, u
tal-ħaddiema li jikkoperaw u jaderixxu mal-miżuri mifthema sabiex titħares
is-saħħa u s-sigurtà tagħhom stess.

 L-appell imur ghall-maniġment biex jagħti każ
u jagħti ċans lill ħaddiema li jikkontribwixxu lejn l-identifikazzjoni
tar-riskji u t-twettieq ta' miżuri li jnaqqsu r-riskji. Kif tirrikjedi l-liġi,
r-rapreżentanti tal-ħaddiema għas-saħħu u s-sigurtà fuq il-post tax-xogħol,
għandhom rwol importanti x'jaqdu. Dawn iridu jservu ta' pont bejn il-ħaddiema u
l-maniġment.

Din is-sena intefghu ħames
sottomissjonijiet li ġew evalwati skond il-kriterji stabbiliti mill-aġenzija
għas-saħħa u s-sigurtà ta' l-unjoni ewropea. Minn dawn kien hemm erba'
fil-kategorija ta' ‘l fuq minn 100 ħaddiem u waħda li timpjega anqas minn 100 ħaddiem.

Il-kriterji tal-evalwazzjoni jinkludu
fost oħrajn, ir-relevanza tas-sottomissjoni, parteċipazzjoni effettiva
tal-ħaddiema, implimentazzjoni b'suċċess, titjib reali, sostennibiltà
maż-żmien, trasferibbiltà lejn postijiet tax-xogħol oħra u li preferibbilment
ikunu innovattivi u jmorru lil hinn mir-rekwiżiti minimi rikjesti
mill-leġiżlazzjoni.

 Is-sottomissjonijiet trattaw suġġetti varji,
b'miżuri sempliċi li ma jinvolvux ħafna spejjes iżda xorta waħda huma effettivi
sabiex inaqqsu r-riskji u oħrajn li huma aktar speċjalizzati għall-industrija
jew kumpaniji partikolari.

 Il-fattur komuni hu l-prevenzjoni jew
it-tnaqqis tar-riskji. Kullħadd jaf li inċident fuq il-post tax-xogħol  jikkawża tbagħtija u telf lil-min iweġġa kif
ukoll lil min iħaddem. Meta l-maniġment jikkonsulta u jinvolvi lil-ħaddiema,
jinkisbu riżultati aktar effetivi, jiġu evitati l-inċidenti u b`hekk jirbaħ
kullħadd.

Is-sottomissjonijiet kollha kienu ta'
livell għoli. Kollha kienu ppreparati u ppreżentati b'mod professjonali u
b'informazzjoni ddetaljata li għamlet x-xogħol tal-Board tal-Evalwazzjoni aktar
facli. Grazzi lill-Inġ. Vincent Attard – Chairman, is-Sur Joe Delia, s-Sur
Victor Carachi u s-Sur Silvio Farrugia membri tal-Board.

Kif ġara fl-aħħar edizjoni ta' din
il-kompetizzjoni, iż-żewġ sottomissjonijiet li ġew fl-ewwel post f'kull
kategorija se jiġu mibgħuta l-aġenzija Ewropea għas-saħħa u s-sigurta fuq
il-post tax-xoghol sabiex jikkompetu għal premju ta' prattika tajba fuq livell
ewropew. Nawguraw li jkollna suċċess kif kellna fl-edizjoni ta' qabel din.
Nħeġġu lil-kumpaniji kollha sabiex jieħdu dan is-suġġett bis serjeta sabiex
jitnaqqsu l-perikli fuq il-ħaddiema. Min iħaddem għandu jfittex il-kontribut
tal-ħaddiema u r-rapreżentanti tagħhom billi jikkonsulta magħhom. Il-ħaddiema
wkoll għandhom id-dritt u huma fid-dmir li jagħtu sehemhom għax b'hekk ikun
assigurat li l-miżuri li jiġu identifikati, ikunu implimentati u jirnexxu.

Good Practice Awards
2012 gew pprezentati mill-Onorevoli Ministru ghas-Sahha l-Anzjani u kura
fil-kommunita', Joe Cassar, flimkien ma Dr Mark Gauci – CEO u Remigio Bartolo,
Focal Point Manager, OHSA. Mistiedna ghall-Konferenza, Ms Boglarka Bola,
Network Manager, European Agency for Safety and Health at Work.

EU and China trade disputes


EU trade commissioner Karel De Gucht
has said the bloc will not back down from protecting its industries against
unfair Chinese competition, but will rely on mutual self interest to prevent a
trade war. The paper says disputes between
Brussels and Beijing have increased in recent months, with the EU bringing it
biggest ever trade case against China over European industry accusations of
solar panel dumping.

The EU is also gathering evidence for
an illegal subsidies and dumping case against Chinese telecoms companies Huawei
Technologies and ZTE.

EU diplomats say De Gucht may be using
the solar panel case in Europe as leverage in an attempt to force China's
Communist government to cut what they see as illegal telecoms subsidies and
avoid another formal trade case.

Meanwhile, the 10-member association of
southeast Asian nations (Asean) is drawing lessons from Europe as it embarks on
its own economic community. The launch of the Asean economic community,
scheduled for the final day of 2015, will be similar to the EU's single market
and Europe's experience with absorbing former eastern bloc countries could be
instructive for the region.

WOULD YOU GIVE A STRANGER €50?


Probably not! Yet everyday, this is exactly what
happens with thousands of businesses in Malta. With the current economic
situation, trading at home and abroad is difficult enough, without the added
worry of not being paid. In certain industries, extended
credit terms are expected, leading to dire consequences when services and goods
are provided and the payment is late or more extreme, non-existent.

As Malta is a small country, there is
a general belief that most people know each other, or know someone who knows
them, especially in the business arena. Yet how many companies or traders would
openly admit to having cash flow problems or financial difficulties? This can
also relate to your existing customers with whom you have been trading with for
a number of years.

Every business needs a process or
system which minimises this risk. Whilst there are many different ways to
achieve this, some are more reliable and proven than others.

The best and easiest method is to
credit check. This simply involves obtaining a report on a company (a lot of
these reports are now available on line from companies such as Creditinfo Malta
Ltd and available to purchase via a tailored package to suit your company
needs, making them easily affordable). These reports contain financial
information, confirmation of their address, the directors/owners and if they
have any outstanding debts. This information can be critical when dealing with
new customers. You need to make sure that the company you hope to trade with
will be able to pay their bills. Even though such checks are no guarantee of
payment, the report will provide information whether there is a greater chance
of receiving payment, rather than just relying on a word of mouth reference.

If you are a small company and have a
chance to win a tender working with a large organisation, it is probably likely
you would work with them even if they have a bad credit report. Statistics show
that some of the worst payers are the larger companies who sometimes use their
position of strength to obtain more favourable credit terms.  If you credit check the organisation first,
you would enter the relationship with your eyes open. The knowledge you would
have from the report would provide you with the opportunity to put a provision
in place for potential late payment or highlight the need to negotiate a
certain percentage of the invoice in advance.

It is not just new customers that
need credit checking, it is good practice to regularly check your existing
customers to see their credit worthiness. 
As we are all too well aware, nothing is constant in business,
especially in the current economic climate where even long established,
reputable businesses have been failing. Establishing regular business checks is
an important and simple process for every business. This can be easily achieved
by a monitoring system helping your business to regularly monitor your
suppliers.  This can be carried out by
most credit checking companies, which enables you to continuously review your
suppliers credit report, so if there are any changes in their financial
wellbeing, you will be alerted.

Imagine if your main supplier goes
out of business, how quickly could you replace them? How would this effect your
organisation? What if they hadn't supplied you with the goods and services you
had pre-paid for – how would you recover the monies you'd paid to them and
where would you now source the products/services which you required?.

Even if the company which you are
trading isn't a bad debtor, a late or delayed payment could still cause you
severe cash flow issues. With limited finance available in the market at
present, do you really want to put your business under unnecessary strain for
the sake of a five minute credit check? Remember prevention is better than
cure!

In order to minimise your exposure to
bad debt, company failures and over-reserving, you must have knowledge of your
customers' and suppliers' financial strength. 
This can be seen by looking at their credit history and changing
financial patterns as shown on credit reports. If you are looking for new
customers and sales you need to make well informed decisions and not guess
credit limits.

One area a lot of firms forget to
review is their own credit worthiness. Do you know what information is
currently in the public domain in relation to your firm? Have your accounts
been filed correctly? Has there been an error or incorrect information been
placed against your firm?

You may not find this out until it is
too late and you and/or your company are refused credit by other companies who
have reviewed a credit report on your firm.

Every business needs to have a clear
and concise system to deal with credit risk. 
This process should review credit limits in line with your terms of
trade.  Company credit reports will help
you to establish these systems.

Remember a sale is not a sale until
the money is in the bank.

In most cases all you need to do is
save yourself one bad debt and the credit reports will pay for themselves.

Now ask yourself again would you give
a stranger €50?

 

Article by Mr. Simon Camilleri

Creditinfo Malta Ltd – Country
Manager

Profile

Simon Camilleri, Country Manager,
Creditinfo Malta has over a decade of experience in setting up and developing
innovative credit risk management companies throughout Europe, as well as
providing independent consultancy in this field and from his ten years in the
insurance industry

Valletta to be the Europe’s capital of culture in 2018


Valletta was unanimously named European
Capital of Culture (ECoC) for 2018 by a jury of experts, following a
presentation by the Valletta 2018 Foundation on October 12. The ECoC jury
chairman Manfred Gaulhofer said that the jury was convinced that Valletta had
the will, motivation and the required ambition to receive the title. Minister
for Tourism, Culture and the Environment Mario de Marco, said that this is very
positive news for the cultural and artistic sectors in Malta. The title of ECoC
can lead to the opening of numerous opportunities in the sectors of the arts
and culture in Malta. The EU Council will officially declare Valletta as the
title holder for 2018 in May of next year.

Climate Action

European Commission teams up with businesses, environment groups and
universities to promote climate solutions. Connie Hedegaard, European Commissioner for Climate Action,
launched a pan-European communication campaign in collaboration with more than
70 organisations from across Europe.

Under the slogan "A world you like.
With a climate you like" the campaign seeks to put practical solutions at
the centre of the climate change debate and demonstrate how climate action can
increase welfare and bring economic benefits to European citizens.

Across Europe there are abundant
examples of intelligent, innovative climate solutions that reduce CO2 pollution
while also improving people's quality of life. For example, Stockholm's central
rail station converts the body heat of commuters into heat for a nearby office
building, reducing not only emissions but also the building's energy bill by
20-25%. In Denmark, the Gedved school in Horsens saves €30,000 a year on energy
thanks to solar power. The money saved is spent on improving education.

Such "win-win" solutions –
where saving money, time and greenhouse gas emissions go hand in hand – are at
the centre of the communication campaign launched by Commissioner Hedegaard at
London's City Hall.

"We have a choice: We can ACT on
our knowledge about climate change. Or we can sit idly by and watch as things
get worse. Both options come with a price tag. So why not create a world we
like, with a climate we like – while we still have time? With this campaign we
want to focus the debate on the solutions and find out what is holding us back
from applying them," said Connie Hedegaard.

Centred on a website which will soon be
available in all 23 EU languages, the campaign is designed as a platform for
participation where individuals, businesses and local groups will be able to
upload, promote and discuss their low-carbon solutions and take part in a
pan-European contest to find the best and most original one.

Partnerships with like-minded
organisations are a central part of the campaign. More than 70 organisations
are already confirmed campaign partners, including business associations,
universities, non-governmental organisations and government institutions. The
intention is to enrol more partners as the campaign evolves.    At the launch event "Visions for a
world you like", campaign partners and citizens have joined Commissioner
Hedegaard, UK Secretary of State for Energy and Climate Change Ed Davey and
other speakers to kick off the debate. The discussions are being streamed live
on the campaign's Facebook page and contributions can be made on Twitter.

More events will follow in a number of
Member States, including Bulgaria, Italy, Poland and Portugal, in the course of
2012-2013.

Background

The campaign will run until the end of
2013 and aims to showcase existing cost-efficient solutions for achieving the
EU's objective of an 80-95% reduction in greenhouse gas emissions by 2050.

It is a follow-up to the Commission's
"Roadmap for moving to a competitive low-carbon economy in 2050" from
March 2011, which sets out pathways for deep but cost-effective emission
reductions by the main economic sectors. 
The Roadmap shows that building a low-carbon economy will increase
investments in clean technologies and infrastructure such as smart electricity
grids, and will drastically lower import bills for oil and gas.

In the medium-term, by 2020, the EU
aims to reduce greenhouse gas emissions by 20%, improve energy efficiency by
20% and boost the share of renewables in the energy mix to 20%. Currently, EU
emissions are more than 17% below 1990 levels.

Further
information

  • The launch event is being streamed live on the
    campaign's Facebook page at www.facebook.com/EUClimateAction. The discussion
    can be joined on Twitter at #worldulike.
  • Campaign website: http://world-you-like.europa.eu.
    Press information and photos are available on the site.
  • List of EU-wide projects:
    http://world-you-like.europa.eu/en/success-stories
  • For more information about the Roadmap for moving to a
    competitive low-carbon economy in 2050, see DG Climate Action's website at
    http://ec.europa.eu/clima/policies/roadmap/index_en.htm.

 

5+5 Summit focuses on the stability of the euro area


Prime Minister Lawrence Gonzi chaired
a meeting of EU leaders present for the 5+5 Summit. The meeting focused on the
economic situation in the euro area in view of the European Council of October
18 and 19. French President François Hollande, Spanish Prime Minister Mariano
Rajoy, Italian Prime Minister Mario Monti, Portuguese Prime Minister Pedro
PassosCoelho and Prime Minister Gonzi reiterated their call for a swift
implementation of the decisions adopted by the European Council in June.

They
agreed on the opportunity that the meeting of the European Council represents
in order to pave the way towards the establishment of a European banking
supervision system. This will be decided before the end of the year and,
ultimately, the solution of the crisis. They also confirmed their determination
to work together and to actively contribute to the preservation of the
stability and integrity of the euro area. European Commission President Josè
Manuel Barroso also participated in the meeting. During bilateral meetings with
French President Francois Hollande and Italian Prime Minister Mario Monti, held
respectively on the margins of the 5+5 Summit, Prime Minister Lawrence Gonzi
stated that Malta is not in favour of a Fiscal Union. However, Malta considers
that an agreement on a Banking Union can be reached. Malta is also opposed to
the proposals for a Financial Transaction Tax.

European
Stability Mechanism

The ESM is a permanent crisis
resolution mechanism for the countries of the euro area. The ESM issues debt
instruments to finance loans and other forms of financial assistance to euro
area Member States. The decision leading to the creation of the ESM was taken
by the European Council in December 2010. The euro area Member States signed an
intergovernmental treaty establishing the ESM on February 2 of this year.
By  October 3, all euro area Member  States had ratified the Treaty. The Maltese
Parliament unanimously ratified the Treaty last July 6.

Malta's
position on the MFF 2014-2020

During a meeting with European
Commission President Josè Manuel Barroso on October 6, Prime Minister Lawrence
Gonzi explained Malta's position on the EU's Multiannual Financial Framework
(MFF) for 2014-2020 and the need for a particular solution for Malta.The
Union's Cohesion Policy is important for Malta to strengthen its
competitiveness and, therefore, the Commission should understand Malta's unique
position as an island-state. Dr Gonzi also mentioned the particular situation
of Gozo and referred to his letter sent to President Barroso last July in which
he invoked the provisions of Declaration 36 of the Treaty of Accession "on the
Island Region of Gozo". In reply, Mr Barroso stated that he recognises Gozo's
particular situation and that his wish is that agreement on the MFF is reached
by the end of this year. The MFF will be the main subject of a special meeting
of the European Council to be held on November 23. President Barroso also
thanked Malta for its positive and constructive contributions within the EU.
The Commission's president also had a meeting with the Leader of the
Opposition, Joseph Muscat, which focused on Malta-EU Affairs.

World Bank Publication Shames Malta’s Progress

The Report of the World Bank: Doing Business
2013 alarmingly ranked Malta with countries of the like of Syria, Madagascar
and Tajikistan! In all the 20 years of combating bureaucracy we thought we had
reached a good point or at least some improvement was made and not that we
would be shamed on an international level.

GRTU complained with the top
Government officials on how they could let something like this happen that puts
Malta in such a bad light. Someone should be responsible to see that the
criteria of measurement are right. GRTU is very much aware that MEPA is still
far from being business friendly and it is reflecting badly on everyone. The
report is however too negative and unrealistic and who made a fool of us must
be kept responsible and ensure that next year we get the recognition we deserve
and a ranking that reflects this. The result reflects incompetence. An
investigation must be carried out and action needs to be taken.  The picture shows how Malta ranked. The
highest rank possible being 1 and the lowest rank possible is 186
Malta Chamber of SMEs
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