Medical Devices Directive and In-Vitro Diagnostics Directive
Europe Market Access - CE marking from a local Notified Body
The European Union is the 2nd largest global market for medical devices and sought after by global medical device manufacturers as a way to extend R&D investment in secondary markets. UL customers benefit from having access to local experts who can conduct the technical file review in-country, in the local language and also apply their knowledge to the Annex II audit. It's our local level of service that has set the standard for market access to the EU.
September 2012 - Updates on Proposed Medical Devices Regulations
On September 26, 2012, the European Commission (EC) adopted proposals to revise the EU regulatory system. The Commission proposals will be discussed in the European Parliament and in the Council. They are expected to be adopted in 2014 and would then gradually come into effect from 2015 to 2019. All the documents and the press release are available on the EC website at: http://ec.europa.eu/health/medical-devices/documents/revision/index_en.htm
Some of the anticipated changes specifically to the IVD regulations are covered in UL's on-demand webinar "The Changing Regulatory Landscape for In Vitro Diagnostics." Click this link for more information: http://lms.ulknowledgeservices.com/catalog/display.resource.aspx?resourceid=409111
Medical Devices Directive (MDD)
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 Class III active medical devices.
In-Vitro Diagnostics Directive (IVDD)
UL has experienced staff with over 100 years of combined experience with 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
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. Click here to learn about UL's Simple Transfer Process.
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 complete 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 and 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.
Notified Body Toolkit -- A 26-page electronic resource that provides valuable information about the EU Notified Body system. Click here to download a free copy.
UL places the utmost importance on the integrity and impartiality of its management system certification activities and the trust it conveys to its clients, their customers and the public at large. The principles inspiring this confidence include impartiality, competence, responsibility, openness, confidentiality, and responsiveness to complaints. These principles are identifiable in UL's Mission Statement. If any internal or external person or body should ever have concern of a situation that may threaten impartiality, it should immediately be brought to the attention of the UL Health Sciences industry General Manager.
Information on UL's Notified Body Certificate
Upon satisfactory completion and approval of the UL assessment, UL will issue an European Commission or "EC" certificate. When the EC certificates issued to the manufacturer demonstrate that the product conformity assessment procedure has been completed (per Article 11 of the MDD), the product may be CE marked in accordance with Annex XII.
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At UL our goal is to continually improve our service to our customers and the customers of UL subscribers. Should you have any feedback, please contact us and we will respond accordingly.
- *NEW* On Demand Webinar update on the proposed EU regulations: "The Changing Regulatory Landscape for In Vitro Diagnostics"
- Download "12 Keys to Meeting Revised Clinical Evaluation Report Requirements for EU Notified Body Submissions" (Registration required)
- Download "UL's Notified Body Toolkit" - Now including information on Clinical Evaluation data required under the MDD (Registration required)
- Download "Future of the Notified Body System" article (Registration required)
- Download UL's June 2009 regulatory update on the revised MDD (Registration required)
- The revised Medical Devices Directive, 2007/47/EC became mandatory in March 2010. To download a summary of the changes click here (Registration required)
- Link to Medical Devices Directive 93/42/EEC
- Link to IVD Directive 98/79/EC