Compliance with legislation and standards is fundamental to Vernacare’s philosophy in all areas of the business.
This results in high quality products that exceed the appropriate product and manufacturing standards and meet the rigorous demands of customers, whilst offering value for money.
Making Products Legal
The majority of products manufactured by Vernacare 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 business or overseas manufacturers, this need for statutory compliance may not always be fully understood or may be inadvertently overlooked. At Vernacare, 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.
Medical Devices Regulation (EU) 2017/745
The Medical Devices Regulation places legal obligations on manufacturers to ensure that their devices are safe and fit for their intended purpose. It replaces the Medical Devices Directive 93/42/EEC in the European Union.
This harmonised Regulation applies in all countries within the European Union, which means that compliant products identified by the CE mark may be traded freely anywhere in the EU. It is illegal to sell a medical device that does not have a CE mark and meet the requirements of the legislation. However, the presence of a CE mark is not a guarantee that the product is fully compliant or of an acceptably high quality.
In each country, or member state, a Competent Authority is responsible for implementing the Regulation and ensuring that manufacturers comply with the regulations.
Medical Devices Directive 93/42/EEC
The Medical Devices Directive is European legislation that is enacted in UK law by The Medical Devices Regulations 2002, Statutory Instrument 2002/618, as amended by SI 2008/2936. As the Medical Devices Regulation 2017/425 had not been implemented at the time of Brexit, medical devices in the UK must be compliant with the Directive. Products that are sold in the UK must carry either the CE mark or the new UKCA mark, demonstrating compliance with UK legislation.
In the UK the Secretary of State for Health, acting through the Medicines and Healthcare products Regulatory Agency (MHRA), is the Competent Authority responsible for implementing the Directive. The MHRA is also responsible for implementing The Medicines Act 1968, which provides the legal framework for the licensing and control of medicines in the UK. Responsibilities also include approvals for manufacturers to carry out clinical investigations and the collection, evaluation and publication of adverse incident reporting.
The Competent Authority designates independent certification organisations, called Notified Bodies, that check and certify that manufacturers of medical devices comply with the regulations. A manufacturer can use any Notified Body registered in the EU to carry out conformity assessment procedures required by the Regulation and/or Directive.
Vernacare uses the internationally respected UK/EU Notified Bodies, BSI and SGS to carry out conformity assessment of its medical devices. Customers therefore have the assurance that assessments are being carried out by a long established and experienced organisation.
Essential Requirements of CE Marking
The Medical Devices Directive and Medical Devices Regulation set out the requirements that have to be met and how manufacturers must comply. Medical devices are grouped into four classes, which are subject to different levels of control to gain compliance. The higher the inherent degree of risk to patients or users that a device presents, the higher the level of control is required for CE/UKCA marking. The different classes of medical devices are as follows:
- Class I - Generally regarded as low risk
- Class IIa - Generally regarded as medium risk
- Class IIb - Generally regarded as medium risk
- Class III - Generally regarded as high risk
When considering a new product, the manufacturer must first determine whether it is a medical device and if so, which class it belongs to. This is determined using the rules in Annex VIII of the Regulation (Annex lX of the Directive). If more than one rule applies to a device, the highest classification stands.
General Safety and Performance Requirements
Each device must meet a number of ‘General Safety and Performance Requirements’ as stated in Annex l of the Regulation and Directive. Demonstration that the device complies with these requirements forms part of the technical documentation required for all class of device. These requirements cover elements of the design, manufacture and packaging such as:
- Safety of patients and users
- Eliminating or addressing any risks associated with the use of the product
- Performance of the device, including over its life period
- Biocompatibility, toxicity and flammability
- Elimination or reduction of any infection risk
- Maintenance of sterility (sterile devices)
- Appropriate environmentally controlled manufacturing conditions
- Accuracy and stability of measuring function (measuring devices)
- Correct, unambiguous labelling
Cosmetic Products Regulation (EC) No 1223/2009
The safety of cosmetic products is ensured by compliance to the Cosmetic Products Regulation, enforced in the UK by the Secretary of State for Trade and Industry. Cosmetics products must be notified on UK/EU portals, having undergone safety assessment and microbiological testing. Vernacare cosmetic products include personal cleansing wipes.
Biocidal Product Regulation (EU) 528/2012
Products designed to manage or kill microorganisms are regulated as Biocides and fall under the remit of the EU Biocidal Products Regulation. Biocidal Products are not CE marked like medical devices or PPE but are subject to approval by Competent Authorities. The UK Competent Authority is the Health and Safety Executive (HSE). Vernacare biocidal products include surface wipes, hand sanitisers and sachet wipes.
PPE Regulation (EU) 2016/425
The PPE Regulation is European legislation that ensures PPE products are safe and fit for purpose. Much like medical devices, conformity to the PPER is demonstrated by the application of CE/UKCA marking and is overseen by selected Notified Bodies. The UK Competent Authority for PPE is the Health and Safety Executive (HSE). Vernacare personal protective equipment products include examination gloves, foam earplugs and disposable aprons.
HTM 07-01 – Safe Management of Healthcare Waste
Vernacare adopts the key recommendations of the HTM 07-01 Safe Management of Healthcare Waste Guidelines and incorporates near patient sharps disposal (NPSD), helping to reduce the risk of needlestick injuries.
- Replaces Health Services Advisory Committee’s (1999) guidance document ‘Safe Disposal of Clinical Waste’
- Guidance produced to provide a framework for best practice waste management to help healthcare providers and other producers to meet legislative requirements
- Guidance focuses on the management of medicinal and infectious waste
- Key recommendations of HTM 07-01
- A new methodology for identifying and classifying infectious and medical waste that complies with health and safety, transport and waste regulations (the new methodology is described as the Unified Approach)
- A revised colour-coded best practice waste segregation and packaging system
- An offensive/hygiene waste stream to describe waste that is non-infectious (human hygiene waste)
- The inclusion of European Waste Codes (EWC) on waste documentation (consignment notes) for healthcare waste in-transit on public roads
Download a copy of the HTM 07-01 Safe Management of Healthcare Waste from the Department of Health website.
HTM 07-01 – Guidelines
HTM 07-01 - Safe Management of Healthcare Waste Guidelines oblige NHS Trusts to segregate clinical waste into specific colour coded waste streams, according to the nature of the waste:
- Sharps Waste Partially Discharged (For INCINERATION)
- Partially discharged and empty sharps including those contaminated with medicines other than those that are cytotoxic and cytostatic
- Sharps Waste Non Pharmaceutically Contaminated Sharps (For INCINERATION or ALTERNATIVE TREATMENT)
- Non pharmaceutically contaminated sharps not contaminated with medicines including cytotoxic and cytostatic medicines
- Cyto Sharps Waste (For INCINERATION)
- Sharps including those contaminated with cytotoxic and cytostatic medicines
- Solid Pharma Waste (For INCINERATION)
- Clinical waste, surgical instruments and other infected clinical wastes not suitable for disposal in sharps containers or plastic bags
- Anatomical Waste (For INCINERATION)
- Identifiable anatomical waste
EU Directive 2010/32/EU - Prevention of Sharps Injuries in the Healthcare Sector
As set out in the Health and Safety Executive the aims of the Directive are as follows:
- To achieve the safest possible working environment
- To prevent workers’ injuries caused by all medical sharps
- To protect workers at risk
- To set up an integrated approach establishing policies in risk assessment, risk prevention, training, information, awareness raising and monitoring
- To put in place response and follow up procedures
How does the EU Directive affect me?
The EU Directive is aimed at employers, requiring them to make appropriate provisions for health care staff in respect of the risk of sharps injuries. It is the employer’s duty to ensure the health and safety of workers. Health and safety law is criminal law, and healthcare organisations can be subject to enforcement action if they fail to comply with the legal requirements relating to the prevention of sharps injuries.
EU Directive - Risk Assessment
The directive reinforces the need for appropriate levels of training and equipment. A risk assessment must be carried out and where there is a risk of exposure, employers need to identify how exposure can be eliminated. Where exposure cannot be eliminated exposure should be prevented through:
- Providing sharps disposal equipment as close as possible to where sharps are being used
- Banning the practice of re-sheathing
- Implementing safe procedures for using and disposing of sharp medical instruments and contaminated waste
- Eliminating the unnecessary use of sharps
Employers should be aware of their legal duties under existing legislation and the new directive, which emphasise carrying out risk assessments on the prevention of sharps injuries. There should be a strategic level commitment to reducing sharps injuries.
Health and safety law is criminal law, and health care organisations can be subject to enforcement action if they fail to comply with the legal requirements relating to the prevention of sharps injuries.
In 2010, a hospital trust was fined more than £20,000 after a health care worker contracted hepatitis C following a sharps injury. The trust was found guilty of breaching the Health and Safety at Work Act and the Control of Substances Hazardous to Health Regulations (HSE, 2010).
According to www.needlestickforum.net, 100,000 needle-stick injuries occur each year in the UK (Safer Needles Network. 2006).
Download a copy of the Council Directive 2010/32/EU or for further information you can also visit the Health and Safety Executive website.
BS EN ISO 23907-1:2019
ISO stands for 'International Organisation for Standardisation'. Getting ISO accreditation means that you've proved your services and processes are world-class in their quality, safety and efficiency.
Vernacare participate in international committees that discuss and agree upon the standards set and ensure these standards are met from initial product development right through to production.
BS EN ISO 23907-1:2019 specifies requirements for single-use sharps containers intended to hold potentially hazardous sharps medical waste with or without sharps protection features, e.g. scalpel blades, trocars, hypodermic needles and syringes.
The main changes in BS EN ISO 23907-1:2019 compared to the previous edition are as follows:
- An increase in resistance to needle penetration
- Annex A 'Additional explanation of the rationale underpinning this document' created and deletion of the previous Annexes A/B
BS EN ISO 23907-1:2019 (continued)
- New requirements for the permanent and temporary closures
- New requirements on resistance to fall damage
- Clarification of the procedure for the resistance to penetration and the resistance to damage and leakage after dropping test methods
- Addition of a new test method for resistance to spillage by toppling
At Vernacare, our Sharpsafe® products comply with the highest applicable product standards and legislation, including BS EN ISO 23907:2019.
We have a strong engineering capability and state of that art facilities with all products being designed in-house from research and development, to final production.
Veterinary Medicinal Products Directive 2001/82/EC
Enacted in UK law by the Veterinary Medicines Regulations 2009, SI 2009/2297 and enforced by the Veterinary Medicines Directorate (VMD). Vernacare products include veterinary poultice dressings.
In order to comply with these various regulations, Vernacare 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.
In addition to using BSI and SGS for all medical devices conformity assessments, Vernacare also used BSI and SGS to independently certify compliance with a number of other very important standards. These include:
- BS EN ISO 9001:2015 - Quality Management System Certification
- BS EN ISO 13485:2016 - Medical Devices Quality Management System Certification
- BS EN ISO 14001:2015 - Environmental Management System Certification
- ISO 22716:2007 - Cosmetics - Good Manufacturing Practices (GMP)
- BS EN ISO 23907-1:2019 - Sharps Injury Protection - Single-Use Sharps Containers
- BRCGS - Global Standard for Consumer Products - Personal Care & Household
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