UL Announces Expansion of both the IVDD and MDD capabilities in 2007!
In the first quarter of 2007, UL announced, scope expansions to provide more capabilities to medical device manufacturers seeking market access to the EU.
MDD Directive
Medical Devices classified under the MDD must be registered with a Competent Authority before they can be sold in the EU bearing the Requisite CE Mark. As a Notified Body under the Competent Authority of the UK, UL's scope under the MDD includes class I sterile, class I measuring, class IIa, class IIb and I class III Active Medical Devices.
IVD Directive
UL has experienced staff with over 100 years of combined experience in In Vitro Diagnostic Devices. UL has full competency and accreditation in IVD List A, List B and self test devices. Our scope of accreditation aligns to meet the diverse and ever changing needs of the IVD industry to include most self-test devices including devices for urine analysis, endocrinology, general biochemistry and chemistry, general immunology, and diabetes diagnosis and management.
UL's Medical Notified Body - an important component in a suite of assessment services
UL supports the medical device industry globally with local services designed to ease EU market access.
Preliminary Assessment - UL can provide an objective and impartial assessment of your Quality Management System and Technical File(s) against the requirements of the IVD Directive or Medical Devices Directive. These assessments can usually be accommodated with a local assessor or via a desktop review process.
Quality Management System Audits - UL has experienced staff in multiple countries qualified to conduct an audit of your Quality Management system against requirements of the IVD Directive or Medical Devices Directive using ISO 13485 as the basis.
Transfer of certification - If you are considering switching to a new notified body, UL can offer a painless, business friendly, transfer process. In accordance with the rules set out for notified bodies we are obliged to take your existing assessments and verifications into account. The UL transfer process can be as simple as a desk-top review of your recent audit reports, internal audit, management review, customer complaints trends and a contents check of a sample of your technical files.
Batch Testing (List A IVD) - UL has established an efficient batch testing process for manufacturers of List A devices. Working with the Paul Ehrlich Institute we are able to offer the highest caliber testing services across the whole range of List A devices.
Own Brand labeling - UL offers full Own Brand Labeling Services (OBL) to 'Legal Manufacturers' that choose to apply their own name to products that have been designed and manufactured by an Original Equipment Manufacturer (OEM). UL will take into account the mandatory CE certification held by the OEM in a simple OBL assessment process.
Training & facilitation - UL provides a broad range of modules, drawn from public domain information, that are invaluable in supporting manufacturers that need to establish compliance with the IVD or Medical Devices Directives.
For the official Notified Body Request for Quotation, please contact us at +1-877-854-3577 ext. 49462 or email: Medical@us.ul.com
Additional Resources
Medical Services