Incorporating requirements from IEC 60601, the Medical Device Directive (2007/47/EC) is a mandatory step in the CE Marking process for medical products ranging from wheelchairs to bandages to diagnostic equipment. The MDD exists to ensure that all devices in the European Union are safe and operate without defect.
Element’s product safety testing can provide all the services a manufacturer needs to meet the requirements of the MDD. There are key aspects which are mandatory and these must be in place before CE marking to this Directive can take place, including:
- Product Safety Testing to show presumption of conformity to the essential requirements of the LVD
- Compilation of a Technical File
- Completion of a Declaration of Conformity (DoC)
We understand that the international standard for Application of Risk Management to Medical Devices is a mandatory requirement when demonstrating compliance to the 3rd Edition of EN/IEC 60601-1. Without this documentation, compliance to EN/IEC 60601-1 3rd Edition is not possible. We can assist you with this and provide support and guidance on ISO 14971 risk management, including:
- Bespoke and one-to-one training
- Documentation and procedure review
- Production of essential documentation
- Mentoring and retainer contracts
Safety testing for the Medical Device Directive
Element is compliant to the medical safety standard IEC 60601-1, which is recognized by public health authorities the world over and is the harmonized standard for equipment under the Medical Device Directive. We offer impartial third party support to manufacturers in all aspects of the CE Marking Directive; from design consultation, full product safety testing, Technical File compilation and review. Our necessary to provide vital market advantage and confidence in placing a product on the market.
Our safety experts understand the challenge of electrical safety testing of medical products for global export, and assist manufacturers in achieving increased speed to market, resulting in successful product launches.
For those that need guidance on the regulatory requirements for a particular product, we can provide Early Stage Qualification (ESQ®) services to support them through the testing and approval of their products and components.
Medical Device Directive Notified Body Services
As a BIS (formerly the DTi) Notified Body under the Medical Device Directive, we provide the testing needed to achieve certification, assistance with the compilation of a technical file, and support for ongoing quality testing.
We also provide Notified body services for the following related directives:
- EMC directive
- Radio Equipment Directive (RED)
- Low Voltage Directive (LVD)
- Explosive Atmospheres directive (ATEX)
The documentation that we issue is in a recognized format and thus should ensure universal acceptability by enforcement authorities throughout the EU.
It should be remembered that the incorrect CE marking of products can carry severe penalties both for the company and for the individual responsible for signing the DoC.
Medical Device Directive Guidance
Covering a wide variety of testing types, the Medical Device Directive applies to a large scope of products. While the current version does not include active implantable devices (link to Understanding the major technical revisions to Medical EMC standard IEC/EN 60601 nucleus article) this will change in 2020 with the introduction of the Medical Device Regulation (MDR). Our experts can help you determine how this will affect your products, if you will need to incorporate additional directives or standards, and what you need to do to remain compliant under new legislation.
Further Medical Device and Safety Certification Services
Our Certification team provides the Certification Services (link) required for Market Access for many countries throughout the world as well as Notified Body Services for Europe.
As a Certification Body Test Laboratory (CBTL) and a National Certification Body (NCB) under the IECEE scheme, we can test and certify your electrical products to the IECEE certification scheme, which has significant market access advantages including reduce test costs and time to market.
Element's Global Approvals team provide further services to help those looking to export their products into the Global Market place.
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