Authorised Representative

As of 21 March 2010, a Single EU/EC European Authorised Representative (Authorized Representative) must be designated by a non-EU manufacturer of medical devices as required by Article 14.2* of Council Directive 93/42/EEC amended by Directive 2007/47/EC.

EC Rep: what is a European (EU/EC) Authorised Representative (Authorized Representative)?

An (EU/EC) European Authorised Representative (also called Authorized Representative) is a natural or legal person established in the EU who, explicitly designated by a non-Euroepan manufacturer, acts on his behalf in carrying out certain tasks required in the applicable directives.

• For the purposes of New Approach directives the Authorised/Authorized Representative must be established inside the Community.
  
  
• The Authorised/Authorized Representative may be addressed by authorities and bodies in the EEA Member States instead of the manufacturer with regard to the latter’s obligations under the New Approach Directives.
  
  
• Commercial representatives of the manufacturer (such as importer, authorized/authorised agent, authorized/authorised distributor), whether or not established inside the Community, are not to be confused with the Authorised/Authorized Representative in the meaning of New Approach directives.
  
  
• The manufacturer remains generally responsible for actions carried out by an Authorised/Authorized Representative on his behalf.

The delegation of tasks from the manufacturer to the Authorised/Authorized Representative must be explicit and should take place in writing, in particular to define the contents of the tasks and the limits of the representative’s powers. The tasks that may be delegated to the Authorised/Authorized Representative according to the directives are of an administrative nature. Thus, the manufacturer may neither delegate the measures necessary to ensure that the manufacturing process assures compliance of the products nor the setting up of a technical documentation, unless otherwise provided for. Further, an EU/EC Authorised/Authorized Representative cannot modify the product on his own initiative in order to bring it into line with the applicable directives.

*Article 14.2 of Council Directive 93/42/EEC as amended by Directive 2007/47/EC:
Where a manufacturer who places a device on the market under his own name does not have a registered place of business in a Member State, he shall designate a single authorised representative in the European Union. For devices referred to in the first subparagraph of paragraph 1, the authorised representative shall inform the competent authority of the Member State in which he has his registered place of business of the details referred to in paragraph 1.

FAQ/Q&A: Questions and Answers about CE Marking of Medical Devices

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LLP Company

Limited Liability Partnerships

A Limited Liability Partnership (LLP) shares many of the features of a normal partnership - but it also offers reduced personal responsibility for business debts.

Unlike members of ordinary partnerships, the LLP itself is responsible for any debts that it runs up, not the individual partners.

The guides below will give you a brief overview of how to register as a Limited Liability Partnership.

For accounting periods starting on or after 06 April 2008 the time allowed for filing accounts at Companies House has been reduced from 10 months to 9. For further information please seeCompanies Act 2006 FAQ.

Limited Liability Partnership Guidance

• GP LLP1 - Limited Liability Partnership Incorporation and Names
• GP LLP2 - Life of a Limited Liability Partnership
• GP LLP3 - Limited Liability Partnership Strike off, Dissolution & Restoration
• GP LLP4 - Limited Liability Partnership Late Filing Penalties

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LLP: A corporate business vehicle that enables professional expertise and entrepreneurial initiative to combine and operate in flexible, innovative and efficient manner, providing benefits of limited liability while allowing its members the flexibility for organizing their internal structure as a partnership.

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Registrar’s Notice Board

Process to Start LLP

Limited Liability Partnership Act 2008 notified on 31.03.2009

Limited Liability Partnership Rules 2009 notified on 01.04.2009

First LLP registerd on 02.04.2009

Conversion of companies and firms notified on 22.05.2009 with effect from 31.05.2009

Taxation for LLP notified on 10.07.2009. Check the press notes on the portal

1728 LLPs are registered as of 02-07-2010

Ministry of Corporate Affairs
1) Every LLP shall mandatorily file Form 3 and Form 4 within 30 days of incorporation failing which Rs.100/- per day will be charged as additional fees on each Form. 2) Form 7 shall be digitally signed by applicant's own DSC. The DSC of other partners and professionals should not be used while applying Form 7.

Ministry of Corporate Affairs

Form 11 is made available at http://llp.gov.in. All LLPs whose financial year closes on 31st March of every year has to file Form 11 within 60 days from the date of financial year closure without any late fee and later it attracts additional fees @ of Rs. 100/- per day of delay. This financial year (closed on 31/03/2010), the due date falls on 30/05/2010. This year Filing of Form 11 before 30/05/2010 is mandatory for all the LLPs incorporated before 01/10/2009 i.e. upto LLP No. AAA-0244 and optional for other LLPs if they are opting closure of Books of Accounts on 31/03/2011 (as 1st Financial Year) instead of on 31/03/2010.

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Energy Management

ENERGY MANAGEMENT BSI provides standards, publications, training, events, software, assessment and certification services for EN 16001 Overview Effective energy management is a crucial issue for the success of any business. For many, the answer is an Energy Management System (EnMS) – a framework for the systematic management of energy. As well as enhancing energy efficiency, an EnMS can cut costs and reduce greenhouse gas (GHG) emissions providing you with a competitive advantage. EN 16001 represents the latest best practice in energy management building upon existing national standards and initiatives. The standard specifies the requirements for an EnMS to enable your organization to develop and implement a policy, identify significant areas of energy consumption and target energy reductions. Feature & benefits ·   Reduce costs ·   Improve business performance ·   Engage top management ·   Reduce your GHG emissions ·   Formalise energy policy and objectives ·   Integrate your management systems ·   Secure energy supply ·   Drive innovation ·   Flexible and scalable How can we help? Assessment and certification Our assessment capabilities are globally recognized for providing a value-added service while our assessors are qualified professionals with relevant product and industry expertise. We also offer integrated assessments with other management system standards, such as ISO 9001 and ISO 14001, to help reduce the burden of multiple assessments.      Benefits of certification       • Continual improvement       • Enhance reputation       • Improve brand image       • Differentiate from competition       • Enhance competitiveness       • Improve staff motivation and retention GET FREE ENERGY MANAGEMENT KIT (For first 50 responses)

EN 16001 will help you establish the systems and processes necessary to improve energy efficiency leading to reductions in cost and greenhouse gas emissions through the systematic management of energy. EnMS Training Courses Introducing Energy Management This course provides a general understanding of the concepts of an energy management system (EnMS) based on EN 16001:2009.  Students will learn how an effective EnMS can help their organization improve its energy efficiency, reduce costs, lower greenhouse gas emissions. Implementing Energy Management Upon completion of this course, students will be able to: ·   Build and establish an Energy management system and culture ·   Understand the requirement of Energy Management system EN 16001 ·   Establish techniques for the implementation process ·   Implement an energy monitoring plan and energy analysis ·   Establish and monitor energy performance indicators CONTACT: VIMITA BANGA AT 9717708106 BSI : BSI India, The Mira, A-2, Ishwar Nagar, Mathura Rd., New Delhi-110065