Author: SME Chamber

The EU Competent Authorities for the Directives on medical devices have reached an agreement on a harmonized approach in the interpretation of the following legal provision: "The label must bear the following particulars: the name or trade name and address of the manufacturer. For devices imported into the Community, the label, or the outer packaging, or instructions for use, shall contain in addition the name and address of the authorised representative where the manufacturer does not have a registered place of business in the Community."

Harmonization, particularly the achievement of a coherent interpretation of legal rules and the scope of those requirements, is an important part of the market surveillance system.

In September 2010 the Competent Authorities in the medical devices sector established the Central Management Committee (CMC) to support and improve a harmonised implementation of the regulatory system. On June 7, 2011 CMC issued a decision to provide market surveillance authorities with a harmonised interpretation of what address a manufacturer (and when relevant an authorised representative) of medical devices shall put on the label and instructions for use.

The address shall be the address of the registered place of business of the legally responsible manufacturer and shall include the following details:

• street/road,
• number/house/floor,
• postal code
• city
• state/region and country

The same details shall be provided for the address of the authorised representative.

The Compliance and Enforcement Group (COEN), was asked to appropriately enforce the implementation of this decision. 

Through this letter, agreed by COEN, the Competent Authorities within the medical devices sector are informing manufacturers, Authorised Representatives and national and European branch organisations of this decision. Competent Authorities within the medical device sector request that manufacturers implement the decision by September 2012. 

The decision will be applied by the market surveillance authorities as from 1^st September 2012 giving industry a transfer period of one year.

The decision and more information of the CMC are available on the following Websites: http://www.cmc-md.eu/; www.cmc-md.eu/decisions.html

Should you require any clarifications please do not hesitate to contact Mr David Pulis at the MCCAA on or 2395 2000.

GRTU President Paul Abela and  Karmenu Zammit representative of the hauliers section has this week conducted a site visit at VGT Deep Water Key. During the visit a container and trailer vessel was effecting unloading and the usual operation. This was carried out as a familiarization exercise and it was agreed that such visits will continue on the future to improve cooperation.

This online consultation provides a large range of international stakeholders with the opportunity to present their views and contribute to set the agenda for next years European Trade and Development actions.

The accompanying issue paper contains useful background information, current issues and the objectives and invites contributions from stakeholders. It also contains a specific privacy policy statement in relation to the personal data protection of participants in the consultation.

http://trade.ec.europa.eu/consultations/?consul_id=156

The Commission is inviting contributions from the stakeholders. The EPD would appreciate if you could circulate the link to the members of your organizations.

Closing Date: 21/08/2011

After decades in which they were somewhat sidelined, Europe's small and medium-sized enterprises have now taken centre stage in the EU policymaking process. Already in 2000, with the adoption of the European Charter for Small Enterprises, EU Member States committed themselves to improve the business environment for smaller businesses:

• take care of the peculiarities of small enterprises in the elaboration of policies, measures and programmes;
• stimulate and promote entrepreneurship;
• improve SMEs' access to finance;
• create an administrative, fiscal, social and economic environment favourable to smaller enterprises;
• promote SMEs' access to the results of R&D and technology; value their innovation potential;
• promote the broadest possible access to new information and communication technologies.

In the Charter, Member States also committed themselves to report every year on the progress made. In 2006, the reporting commitment was integrated in the annual reports foreseen by the Lisbon agenda. 2007 brought a significant step forward as the European Commission announced its intentions to adopt a "Small Business Act for Europe", which was published in June 2008 and adopted by Heads of State and Government in December the same year. When the Small Business Act was published the Commission was moving from a logic that sees SMEs as exception to a stronger, more solid theoretical approach that would quickly bear fruit if fully endorsed, also at Member State level. More than two years after the adoption of the SBA, however, progress has been quite patchy both on the principles and on the concrete actions linked to the text, which remains a non-binding communication.

Despite its shortcomings in form and in practice, the Small Business Act has had the merit of putting SME policy at the forefront of the debate and increasing its level. Some months ago, the European Commission has published a review of the Small Business Act, which stressed the importance of improving the governance of the SBA process.

The GRTU has last week met Jason Azzaopardi where the Small Business Act for Malta was discussed. Government has in this case taken up GRTU's suggestion to entrench the rights enacted by the Small Business Act into law, this following strong criticism that Government has to do something tangible and not limit itself to simple nice rhetoric.   

The Small Business Act for Malta is a very important step and seems to be one that is being regarded as a best practice by the European Commission and is attracting much interest amongst other Member States. GRTU now looks forward to see the it practiced in real terms.

GRTU President Paul Abela, Vice President Philip Fenech and Director General Vincent Farrugia were earlier this month very pleased to meet Mr Martin Bugelli for a cordial introductory meeting at the GRTU premises.

GRTU's Director General and EESC Employers` Group member told Mr Bugelli that "as the national organisation representing SMEs we are extremely happy with your nomination as we have worked together for many years and we know exactly the determination and enthusiasm which dominates your performance. For small business proprietors in Malta it is essential that the EU Commission is represented by a strong personality who is not afraid to reach out to the widest cross-section possible of people, and in our case this is particularly important as in spite of our own efforts through our own electronic newspaper the GRTU newSTRING, which diffuses information and advice to small businesses, and also the efforts of MEUSAC, there are still a substantial amount of people who are under the influence of misinformation about Europe, propagated in the past".

GRTU is very active at European level through our direct representation in the Employers bureau at EESC and in the administration boards of both EuroCommerce and UEAPME and we regularly send delegates to various EU Commission activities, seminars and courses, but we still believe there is much more to be done. GRU offers all its support to make sure that Martin Bugelli excels in his position as Head of the EU Commission representation in Malta. The GRTU officers wished Mr Bugelli the best of luck while occupying the new post.

Waqt li rringrazzjat lill-Kunsill tal-laqgha kordjali organizzata dwar xoghlijiet ta' tisbih/servizzi gewwa Triq San Pawl il-Belt, il-GRTU gibdet l-attenzjoni tal-Kunsill li l-GRTU ghandha tigi involuta aktar dwar xoghol simili sabiex l-komunita' kummercjali tkun infurmata fil-hin bil-proceduri mehtiega u mhux kif appena ser jibda x-xoghol.

Il-GRTU immedjament bdiet tinforma lis-sidien li x-xoghlijiet ser jibdew bejn l-ewwel/tieni  gimgha  t-Awwissu 2011 bl-ewwel fazi (mill-OPM sa Triq it-Tejatru). Bi ftehim mal-Kunsill u mall-Ministeru tal-MRRA il-GRTU kellha tiehu hsieb tara jekk kienx hemm applikazzjonijiet pendenti min naha tas-sidien minhabba utility services etc sabiex dawn jigu mhaffa u jsiru waqt l-andament tax-xoghlijiet. Ftehmna ukoll li dawk kollha li ghandhom kantina jikkomunikaw mall-Kunsill sabiex jigi ikkordinat ix-xoghol skond l-htiega.

Carmen Borg rapprezentanta fi hdan il-GRTU il-bierah fil-ghodu zaret sidien ta' negozji li qeghdin fil-parti ta' fuq fejn ser tibda l-ewwel fazi tax-xoghlijiet. Sfortunatemnet ma setawx jinghataw dettalji cari il-ghaliex l- programm/perjodu ta' xoghol ghadu ma huwiex ikkonfermat, Traffic Management lanqas, u lanqas ma huwa kkonfermat l-hin li l-kuntrattur ser jopera bih.

Is-Sidien ma ghandhom xejn kontra dan ix-xoghol anzi laqghu b'ferh din l-ahbar, pero il-GRTU talbet li kif appena l-Kunsill ikollu ftit informazzjoni jghaddiha mal-ewwel lill-GRTU l-ghaliex hemm sidien li huma ikkoncernati hafna ghal fatt li Triq San Pawl hija wahda mit-toroq ewlenin li bhalissa qed tilqa' hafna mit-traffiku li jwassal ghac-centru tal-Belt.

Il-GRTU gibdet ukoll l-attenzjoni li hafna mis-sidien huma wholesalers, distributuri, restoranti, kaffeteriji, hwienet tal-merca  etc. Dawn ghandhom bzonn li f'certu hinijiet jhottu u jghabbu x-xoghol ghalhekk l-access ghandu jkun addattat mhux ghal klijent u l-impjegati biss.

Il-GRTU talbet ghall-informazzjoni li gejja, kif appena tkun disponibli;

• l-programm/skeda ta' xoghol
• Traffic Management
• Access alternattiv jekk Triq San Pawl tkun maghluqa
• l-hinijiet ta' kif ser jahdem l-kuntrattur ghaddilna kopja sabiex inkun nista ninforma l-kumplament tas-sidien min triq it-Tejatru sa triq l-Arcisqof

GRTU was this morning happy to meet new MEPA CEO Dr Ian Stafrace. This is one of a serious of meetings Dr Stafrace is holding with stakeholders and GRTU was extremely happy to note how Ian Stafrace intends to execute his function with close collaboration and discussions with stakeholders. The general impression after the meeting was that the time when senior MEPA officers hide behind the wall aloof from the realities of practical life is now over.

The GRTU Delegation let by GRTU President Paul Abela, Director General Vince Farrugia, Vice President for the Gozo Business Community Michael Galea and Joseph Attard CEO of Green MT, presented the GRTU's views in representation of SMEs in various economic sectors. GRTU reminded Dr Stafrace that 98.7% of businesses in Malta are small and medium, of which 92% are micro, and that large enterprises constitute less than 1%. The GRTU told Ian Stafrace that we represent 7000 members which together own more than 10,000 enterprises. Our major interest, and this was the main message, is that planning is for the people and the environment belongs to all of us.

GRTU is one organisation that not only speaks about the environment but acts to help its members and Malta in general reach. We accepted the responsibility of waste collection. We are stakeholders not only because we represent business but because we are part of the waste management system.

It is not correct that MEPA has for long been perceived to be owned by architects and developers. Developers  represent only 5% of users, the absolute majority is composed of commercial and industrial services. GRTU also represents a wide cross section of contractors who do not only work on specific development projects but are involved in all economic activities.

GRTU put forward a proposal for MEPA and the Ministry for Finance to aid particular sectors so that the number of applications for the expansion and the creation of places of work will increase. GRTU also demanded that action is taken to reduce the time from submitting the application to obtaining a PA number, during which the screening process takes place to one week as the average delay is too long.

GRTU highlighted the importance that businesses are given special schemes and not reduction of tariffs to encourage small business growth at a lower expense and time delay.

The Malta-EU Steering and Action Committee (MEUSAC) will be organising, on July 28, 2011 at 9:00am, the second of a series of seminars related to the Europe 2020 strategy. This second seminar, themed Roadmap towards a Resource Efficient Europe, will tackle the issue of sustainable growth which requires working towards a more resource efficient, greener and more competitive economy.

There will also be workshops to gather views and ideas on how Malta can best work to reach the targets set for energy efficiency. All those players involved in areas related to environment, energy, transport and use of resources are invited to attend the seminar and to contribute actively in identifying Malta's main challenges and the best way to tackle them.

Those intending to attend the seminar are requested to send an email on by 25^th July 2011. The seminar will be held at The Palace Hotel, Sliema where complimentary parking will be available. Bookings will be considered on a first come first serve basis.

On 15 June 2011 the European Commission adopted a proposal for a revised Directive on electromagnetic fields. The 2004 directive had been previously suspended due to difficulties of implementation in various industrial sectors and notably disproportionate burdens for SMEs.   

The aim of the new proposal is to balance the protection of workers' health and safety with appropriate flexibility and proportionality in relation to the use and development of industrial and medical activities.

Some of the most important changes concern:

• clearer definitions, in particular for adverse health effects inclusion of a revised system for limit and reference values different from the current limit values and action values for the range from 0 to 100 kHz
• introduction of indicators to facilitate measurements and calculations and to give guidance on taking measurement uncertainties into account.
• introduction of some guidance to ensure simplified but more efficient risk assessments in order to facilitate the evaluation work and also to limit the burden on SMEs
• introduction of limited but appropriate flexibility by proposing a controlled framework for limited derogations for industry
• further complementary non-binding measures such as a non-binding practical guide.

Next steps: The proposal will go to the European Parliament and Council for adoption and is subject to co-decision procedure. Formal negotiations are expected to start in September 2011.