Medical Devices - your access to the european market with BSI
BSI would like to correct any recent inferences in the media linking BSI Kitemark to medical devices. The Kitemark is a BSI certification mark but is not used with implantable medical devices.
Medical Devices are regulated by EU directives. Responsibility to ensure the directives are fully implemented falls to each member state and in the UK this is the Medicines and Healthcare products Regulatory Agency (MHRA). Under the auspices of the MHRA, BSI is an independent review body that conducts conformity assessments to the relevant EU Directives.
CE marking for Medical Devices
CE marking is a legal requirement for medical devices intended for sale in Europe.
There are three European CE marking Directives that specifically apply to medical devices manufacturers:
- The Medical Devices Directive (MDD) applies to all general medical devices not covered by the Active Implantable Medical Devices Directive or the In Vitro Diagnostics Directive.
- The Active Implantable Medical Devices Directive (AIMDD) applies to all active devices and related accessories intended to be permanently implanted in humans.
- The In Vitro Diagnostics Directive (IVDD) applies to all devices and kits used away from the patient to make a diagnosis of patient medical conditions.
BSI is designated as a Notified Body with a comprehensive scope under the MDD and the AIMD and can provide the full scope of services under the IVD Directive. These services include:
- Technical documentation/file or design dossier assessment/review
- Device type examination
- Product quality assurance (based in ISO 13485)
- Production quality assurance (based in ISO 13485)
- Full quality assurance (ISO13485)
- Batch verification/release
View the CE Marking for Medical Devices Brochure
Medical Device CE Marking Training
BSI also offers a range of medical devices training courses, including:
Introduction to CE Marking Training Course
CE Marking for the In Vitro Diagnostics Directive Training
Medical Device CE Marking Implementation Training
BSI would like to correct any recent inferences in the media linking BSI Kitemark to medical devices. The Kitemark is a BSI certification mark but is not used with implantable medical devices.
Medical Devices are regulated by EU directives. Responsibility to ensure the directives are fully implemented falls to each member state and in the UK this is the Medicines and Healthcare products Regulatory Agency (MHRA). Under the auspices of the MHRA, BSI is an independent review body that conducts conformity assessments to the relevant EU Directives.
What is CE marking?
CE marking on a product:
- Indicates to governments that the product can be legally sold within the European Union (EU) and the European Free Trade Area (EFTA)
- CE marking is mandated by New Approach Directives and is the manufacturers claim that the product complies to the relevant European Directives
- Ensures the product can move freely throughout the European Single Market
- Indicates to customers that the product meets designated minimum safety standards and therefore a minimum level of quality
- Promotes public health and safety
- Enhances product credibility
- Leads to improved sales and greater customer satisfaction
What are the new approach directives?
The European Union introduced a series of measures to simplify the movement of goods throughout the European Union (EU) and the European Free Trade Area (EFTA). Some of these measures are known as New Approach Directives. New Approach Directives provide controls on product design and above all, seek to harmonize product safety requirements across Europe.
The directives cover a very wide range of product areas including toys, medical devices and pressure equipment. Their primary objective is to ensure that the products are well designed, and safe for the user.
Throughout Europe, where a New Approach Directive is in force, it is necessary for the manufacturer to CE mark their product.
What is a Notified Body?
A Notified Body is an organization that has been nominated by a member Government and Notified by the European Commission. A Notified Body will be nominated based on designated requirements, such as knowledge, experience, independence and resources to conduct the conformity assessments.
What are the benefits of CE marking?
The EU introduced the CE marking scheme to make trade easier and cheaper between EU countries. It means that a manufacturer claims that their product conforms to the minimum legal requirements for health and safety as laid down in EU directives.
Often customers will look for CE marking on a product as an indication of conformance to laid down minimum standards, and therefore a minimum level of quality that other products may lack.
Why choose BSI?
As such BSI has a wealth of experience in helping companies to attain CE marking for their products. Our technical experts are available to help guide you through the process to make it as painless as possible.
BSI would like to correct any recent inferences in the media linking BSI Kitemark to medical devices. The Kitemark is a BSI certification mark but is not used with implantable medical devices.
Medical Devices are regulated by EU directives. Responsibility to ensure the directives are fully implemented falls to each member state and in the UK this is the Medicines and Healthcare products Regulatory Agency (MHRA). Under the auspices of the MHRA, BSI is an independent review body that conducts conformity assessments to the relevant EU Directives.
The CE marking process
At BSI, we have a team of experts who understand precisely what each Directive requires for each product. We can help take you through the CE marking (CE mark) process in these simple steps:
- Identify the Directive(s) that are applicable to your product.
You can download these directives free of charge from the European Union website
- Identify the conformity assessment procedure that must be taken.
This could be self-declaration, involve testing, inspection or quality system assessment from a Notified Body or a combination of these. The conformity assessment procedure will differ depending on your product and the Directive in respect of which you will be CE marking (CE mark). If you are unsure about which procedure to take, please contact us for advice.
- Determine the dates by which you must take action.
This will be the date that the Directive comes into force. The majority of directives are already in force. In these cases, it is an offence to place a product on the market without CE marking because it indicates a presumption of conformity with all relevant Legislation.
- Identify if there are any Harmonised European Standards applicable to your product. These are not always mandatory for manufacturers although there is a presumption that conformity to these standards will give conformity with the relevant part of the Directive. Whenever possible or appropriate, manufacturers should follow harmonised standards.
- Ensure the product complies with all the essential requirements of the Directive(s). Take appropriate measures to comply or identify existing data and test reports.
- Identify whether independent assessment of your conformity to the Directive, or some aspects of it, is required from a Notified Body. This will be stated in the directive and is dependent upon the product you are CE marking. You must not affix CE marking to your product until all necessary certifications have been obtained from the Notified Body.
- Maintain Technical Documentation required by the Directive(s). Your technical documentation should support your compliance with the requirements of the Directive. It is essential to retain this documentation.
- Prepare the Declaration of Conformity and the required supporting evidence. The Declaration of Conformity along with the Technical Documentation should be available to Competent Authorities (EU Members) upon request.
- Check that no other purely national requirements exist in the countries where the product will be sold. These may include national standards, labelling or packaging requirements.
- Affix CE marking on your product and/or its packaging and accompanying literature as stated in the directive.
BSI would like to correct any recent inferences in the media linking BSI Kitemark to medical devices. The Kitemark is a BSI certification mark but is not used with implantable medical devices.
Medical Devices are regulated by EU directives. Responsibility to ensure the directives are fully implemented falls to each member state and in the UK this is the Medicines and Healthcare products Regulatory Agency (MHRA). Under the auspices of the MHRA, BSI is an independent review body that conducts conformity assessments to the relevant EU Directives.
Achieving the Kitemark for Medical Devices
The Kitemark is a voluntary, independent third-party mark that offers peace of mind for both the consumer and the specifier.
To achieve Kitemark certification requires a manufacturer to have a comprehensive quality management system, based on ISO 9001:2000 or recognised factory production control system combined with initial product type testing and regular audit testing. Once achieved the Kitemark can serve as an enhanced marketing tool in a competitive market, by demonstrating an ongoing commitment to quality and safety.
BSI is proud of owning the Kitemark, and with good reason. It is one of the most well known and respected product certification quality marks in the world. Regular UK consumer surveys tell us that approximately 80% of the British public recognise the Kitemark as a symbol of quality and safety. What's more, over half of them are prepared to pay a price premium for products that bear the Kitemark.
The Kitemark has delivered real business benefits to our licensees. Here are some of the benefits they have gained:
- Increased Sales to Consumers
- Sell more to key specifiers and buyers - with independent third party backing
- Peace of mind
- 'Credit' against other certification requirements
One of the best known Kitemark schemes relating to the medical industry is that for male latex condoms. In addition to this scheme, we also offer the Kitemark for medical gloves, disposable pulp products, packaging materials, sharps containers and systems for medical devices which are to be sterilized and electrical equipment for measurement, control and laboratory use.
