EU Medical Device Regulation: Be Confident of Medical Device Market Approval

Manufacturers of medical devices will soon face major changes in EU regulation decades ago to manage EU market access. MDR replaces the current EU Medical Device Directive (93/42 / EEC) and the EU Transplant-able Medical Device Directive (90/385 / EEC).The Medical Device Regulations were formally released on May 5, 2017, and it came into effect on May 25, 2017. Currently approved medical device manufacturers have a three-year transition period through May 26, 2020, to meet regulatory requirements. For some manufacturers, the new medical device regulation mdr can save additional time after the application date and develop the maximum number of new products four more years in the market. Additional requirements apply during this extended transition period.

Doctor with stethoscope and white icon medical on hospital background, medical technology network concept

How can TÜV help me?

The new MDR places strict requirements on medical device manufacturers and reporting agencies that need to be involved in the approval process for medical devices. The T Product V SÜD Product service is one of the world’s first certification bodies designated as a public body for new medical device regulations, by the National Health Protection Authority (ZLG) for medical products and devices.

With more than 750 medical device professionals in over thirty locations around the world, we are the largest medical device regulatory consultancy licensed to provide certification services under new regulations.

Big changes

MDR differs from the EU directive on implanted and active medical devices in several important ways. The most important changes to the list are:

Product Expansion – The definition of implanted medical devices and implanted medical devices subject to MDR will be expanded to include devices that do not have medical purposes, such as colored contact lenses, cosmetics, and cosmetics. They are also included in a variety of regulated equipment designed to “predict and predict” other diseases and health conditions.

Determination of “Qualified Person” – The device manufacturer must identify at least one person in the organization who is ultimately responsible for all aspects of meeting the new regulatory requirements. The organization must document this person’s specific qualifications for the required tasks. Special relief may apply to so-called SMEs.

Implementation of unique hardware identification: MDRs must use a unique device recognition mechanism (UDI). This requirement is expected to improve the ability of manufacturers and authorities to monitor specific devices throughout the supply chain and to facilitate the rapid and effective recall of safety-critical medical devices. In addition, the European Medical Device Database (Eudamed) is expected to provide effective access to approved medical device information.

Strict Post-Market Control – Aftermarket surveillance by the reporting agencies, MDR seeks increased authority. Undeclared reviews, along with product sampling and product testing, can help strengthen the EU enforcement system and reduce the risk of unsafe devices. In many cases, device manufacturers also need to report annual safety and performance.

• Spec-MDR is a program that allows the EU or the Technical Commission to publish generic specifications that must then be taken into account by manufacturers and reporting agencies. These general specifications must be in combination with uniform standards and the latest technology.
• Re-classify instruments according to the biological evaluation report, risk update, contact time, and MDR device manufacturers, taking into account that Class III and implanted devices have higher clinical requirements and standard audits. Please refer to the classified classification rules and request to update the technical documentation accordingly.
• Stronger clinical evidence for Category III and implanted medical devices – Manufacturers should conduct clinical examinations if there is insufficient clinical evidence to support the safety and function of a dedicated device. Device manufacturers are also required to collect and maintain post-market clinical data as part of the ongoing assessment of potential safety risks.

Systematic Clinical Assessment of Class IIa and Class IIb Medical Devices – Manufacturers will need to re-prepare the clinical evaluation by considering the new language in the timing of equality approaches, the absence of clinical examination can be justified.