Introduction to the EU MDR Compliance

The European Union is the second largest global market for medical devices and often the global medical device manufacturers in the region choose to launch on their own market first because of the choice of Notified Bodies and the adoption of state-of-the-art technologies. UL customers have direct access to Notified Body technical specialists who partner with our customers and want to be a part of their success. The X Vendor Partnership culture is prevalent in our organization and is the way our team works to help our customers stay on track.

Updates to proposed regulations for medical devices (MDRs)

The European Commission (EC) adopted proposals for the review of the EU regulatory system. The documents were published in February 2017 and it is expected that notified bodies will qualify them for designation from 2018. When the new EU MDR comes into force, manufacturers will have four years to apply again for approval or will let their products become obsolete, since the exemption is not allowed. During the transition, which is expected to last until 2024, medical device manufacturers may continue to use their certificates under MDD (Medical Devices Directive).

The MDR has remained basically the same since our original technical report on the topic. In general, major changes include:

• New structure

• The scope of the extended Regulation

• Now over 50 definitions, including many new or updated definitions

• Regulation on clinical investigations of medical devices conducted in the European Union

• Internal exemption

• Common Specifications

• Regulation of products without an intended medical purpose which is listed in Annex XV using common specifications

Preliminary assessment -

UL may provide an unbiased and objective assessment of your quality management system and technical data sheet (s) against the requirements of the Medical Devices Directive. Generally, these evaluations can be adapted with a local consultant or through a computer analysis process.

Quality management system -

UL has experienced teams in several countries and is qualified to perform an audit of its quality management system against the requirements of the Medical Devices Directive with ISO 13485 as the basis.

Transfer Certification -

If you are considering migrating to a new notified body, UL may offer a transfer process without prejudice to your business. In accordance with the rules laid down by notified bodies, we are obliged to take into account your existing assessments and verifications. The UL transfer process can be as simple as computer analysis of your latest audit reports, internal audit, management review, customer complaint trends and a content check of a sample of your technical files.

Virtual manufacturing -

UL offers Full Brand Labeling Services (OBL), now known as Virtual Fabrication services for "Legal Manufacturers" who choose to apply their own name on products that have been designed and manufactured by an Original Equipment Manufacturer). Recent changes now require Virtual Manufacturer to maintain a quality system and more. 

Training and facilitation -

UL provides a wide range of modules, extracted from public domain information, which is invaluable in supporting manufacturers who need to establish compliance with IVD Directives or Medical Devices.