Europe Market Access – Medical Devices Directive 93/42/EEC and Medical Device Regulations
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, 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.
Updates on Proposed Medical Devices Regulations (MDR)
On September 26, 2012, the European Commission (EC) adopted proposals to revise the EU regulatory system. The documents were published in February 2017 and Notified Bodies are expected to qualify for designation as early as 2018. Once the new MDR has come fully into force, manufacturers will have four years to reapply for approvals or let products go obsolete as there is no grandfathering allowed. During the transition, which is expected to last until 2024, medical device manufacturers can continue to utilize their certificates under the Medical Devices Directive.
The MDR has largely remained the same since our original white paper on the topic (see downloads). At a high level, key changes include:
- New structure
- Scope of the regulation expanded
- Now over 50 definitions, including many new or amended definitions
- Regulation of clinical investigations on medical devices conducted in the Union
- In-house exemption
- Common Specifications
- Regulation of products without an intended medical purpose that are listed in Annex XV using common specifications
Medical Devices Directive (MDD) 93/42/EEC
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.
UL’s Medical Notified Body for IVDD and MDD
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 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 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.
Own brand labeling/Virtual Manufacturing —
UL offers complete Own Brand Labeling Services (OBL), now known as “Virtual Manufacturing” services to “Legal Manufacturers” that choose to apply their own name to products that have been designed and manufactured by an Original Equipment Manufacturer (OEM). Recent changes now require the Virtual Manufacturer maintain a quality system and more. Contact UL to find out the impact of these changes.
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 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 Life and Health Sciences industry General Manager using the contact information 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 (per Article 11 of the MDD), the product may be CE marked in accordance with Annex XII.
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**As a Notified Body, MDSAP Recognized Auditing Organization and ISO 17000 series accredited Certification Body we cannot participate in the design, manufacture, installation or distribution of the products we certify or provide consultancy services related to those products. In addition, the UL Notified Body cannot provide certification services to companies that have been provided with consultancy services from other companies in the UL family. We also cannot link our activities to the activities of organizations that provide consultancy services. If you require such services please use an internet search engine to identify relevant providers.