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Quality & Legal Compliance

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Quality, Legislation & Standards

 

Compliance with legislation and standards is fundamental to Robinson Healthcare’s philosophy in all areas of the business, resulting in high quality products that exceed the appropriate product and manufacturing standards and meet the rigorous demands of customers, whilst offering exceptional value for money.

 

Making Products Legal

 

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The majority of products manufactured by Robinson Healthcare have to meet statutory regulations before they can be legally placed on the market for sale. This requires considerable investment in product development, manufacturing standards and quality management systems, combined with a thorough understanding of regulatory affairs and ongoing market surveillance.


For many smaller businesses or overseas manufacturers, this need for statutory compliance may not always be fully understood or may be inadvertently overlooked. At Robinson Healthcare a large team of specialist staff provide the necessary skills and many years of experience to ensure products are safe, fit for purpose and deliver peace of mind to users of the company’s brands. The most pertinent regulations that Robinson Healthcare products adhere to are:

 

MedicalDevices Directive 93/42/EEC, as amended by 2007/47/EC:

Enacted in UK law by The Medical Devices Regulations 2002, SI 2002/618, as amended by SI 2008/2936. Robinson Healthcare products include: most medical products such as surgical instruments, absorbents, woundcare, bandages and first aid products. Enforced by the Medicines and Healthcare products Regulatory Agency (MHRA).


Cosmetic Products Directive 76/768/EEC:

Enacted in UK law by The Cosmetic Products (Safety) Regulations 2008, SI 2008/1284. Robinson Healthcare products include: personal cleansing wipes. Enforced by the Secretary of State for Trade and Industry.


Biocidal Products Directive 98/8/EC:

Enacted in UK law by The Biocidal Products Regulations 2001, SI 2001/880. Robinson Healthcare products include: surface cleansing wipes. Enforced by the Health and Safety Executive (HSE).


VeterinaryMedicinal Products Directive 2001/82/EC:

Enacted in UK law by The Veterinary Medicines Regulations 2009, SI 2009/2297. Robinson Healthcare products include: veterinary poultice dressings. Enforced by the Veterinary Medicines Directorate (VMD).


All of these regulations are intended, as appropriate, to ensure safety for the human or animal that the product is being used on, safety for the user, protection of the environment and efficacy for the task for which it is intended.

 

Complying with Regulations

 

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In order to comply with these various regulations, Robinson Healthcare has to demonstrate that products are manufactured in accordance with the European Directives that are harmonised with UK law. Achieving this usually requires that an official body audit the company’s manufacturing facility. In the majority of cases, the actual product and the associated technical documentation are assessed as part of the auditing process.

 

Compliance with the Medical Devices Directive is enforced in the UK by the MHRA. This government agency ensures that medicines and medical products are fit for their intended purpose and acceptably safe, with far reaching powers to withdraw products from the market and prosecute a manufacturer if the law has been broken. It does not carry out conformity assessments or issue certification. A Notified Body does this – a certification organisation designated by the MHRA to carry out assessments. Robinson Healthcare’s Notified Body is British Standards Institution (BSI) based in Milton Keynes, UK. BSI is also the National Standards Body in the UK.

 

In addition to using BSI for all medical devices conformity assessments, Robinson Healthcare also uses BSI to independently certify compliance with a number of other very important standards. These include 

 

  • BS EN ISO 9001:2008 – Quality Management System certification
  • BS EN ISO 13485:2003 – Medical Devices Quality Management System certification
  • BS EN ISO 14001:2004 – Environmental Management System certification

 

>> View Our Certificates of Compliance