In-Vitro Diagnostics Directive (IVDD) 98/79/EC and new EU IVDR
Europe Market Access – CE marking from a local Notified Body
The European Union is the 2nd largest global market for medical devices and often the region global medical device manufacturers choose to go to market first due to the choice in Notified Bodies and adoption of state of the art technologies. UL-UK is a Notified Body under MHRA, (number 0843) with full-time technical file reviewers and auditors located around the world. UL customers have direct access to Notified Body technical experts who partner with our customers and want to be part of your success. The culture of Partnership versus Provider is prevalent in our organization and the way our team will help our customers stay on the right path.
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.
In-Vitro Diagnostics Regulation (IVDR)
The new IVD and EU regulations were published in 2016. There will be a 5-year transition period and during the transition, manufacturers can apply the IVD Directive or the IVD Regulation. After the transition period, all products placed on the market must meet the regulation or be taken off the market.
The IVDR moves from a list based regulatory structure to a risk-based classification system, based on the GHTF. This means that now, the majority of IVDs are required to have Notified Body approvals, many of which were under self-declaration in the past. The IVDR has additional requirements, so there is no automatic transfer of certification even if the product is already certified under the IVDD. The essential requirements of the IVDD are similar to the IVDR but they are now called General Safety and Performance requirements so even if you have all the data to meet the IVDD you will need to reformat all technical files to prove compliance to the IVDR.
Services to support EU Regulatory Approvals
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. 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 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 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.
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 using the contact information found below.
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 the product may be CE marked in accordance with Annex XII.
Feedback regarding UL subscribers and UL services
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- Webisode Series – 13 quick videos covering the new EU IVD Regulation – 9 minutes or less.
- Article: 11 Critical Considerations for Notified Body Transfer
- August 18, 2016 – Webinar Recording: Changing In Vitro Diagnostic Device Regulations: A Deep Dive into the New EU Requirements for Clinical Evidence
- July 12, 2016 – Webinar Recording: “Broader Regulatory Oversight of IVD – A Deep Dive into the new IVD Regulation“
- June 28, 2016 – Webinar Recording: “Business Impact of the new EU IVD Regulation – An Executive Brief with Sue Spencer“
- On Demand Webinar update on the proposed EU regulations: “The Changing Regulatory Landscape for In Vitro Diagnostics”
- UL White Paper: The Changing Landscape of Medical and In Vitro Diagnostic Device Regulations in the European Union
- UL Third party regulatory approval services page
- Medical Devices Directive 93/42/EEC
- IVD Directive 98/79/EC
- UL’s Notified Body Toolkit – a 34 page resource explaining the EU regulatory system for Medical and IVDs.
Contact UL Health Sciences Team direct:
Toll free in North America: 1.888.503.5537
Within the UL family of companies we provide a broad portfolio of offerings to all the Medical Device industries. This includes certification, notified body and consultancy services In order to protect and prevent any conflict of interest, perception of conflict of interest and protection of both our Brand and our customers brands UL is unable to provide consultancy services to Notified Body or MDSAP customers. UL has processes in place to identify and manage any potential conflicts of interest and maintain impartiality. Read more about this.