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MDD Fact sheets

Scope

The scope of any legislative measure must be as clear as possible to avoid potential confusion and fragmentation in its implementation. It is also essential that product categories included in the scope, are defined clearly and based on sound scientific and technical criteria. Read more...

Economic operators

Economic operators are the various actors involved throughout the medical device supply chain, i.e. manufacturers, authorized representatives, importers and distributors. Read more...

Reprocessing

Single-use medical devices are designed to be used on one single occasion for one single patient. They are designed for optimal performance during one use and have not been validated by the original manufacturer for a second use, including the necessary cleaning, removal of pathogens and sterilization. Certain Member States allow for the reprocessing of single-use devices within their health systems while yet others ban reprocessing on public safety grounds. Read more...

Standards & guidelines

Standards exist for the safety of users, patients and consumers and to provide common technical specifications for regulators and manufacturers of products to demonstrate the correct application of the legal Safety and Performance Requirements. Using standards to underpin safety is a core principle of all global regulatory systems and as such should prevail in Europe as a core vehicle to ensure the safety and compliance of medical devices. Read more...

Early scientific advice

Given the rapid pace of medical device innovation (a new product typically supersedes a previous version with 18-24 months) and the sector’s predominantly SME nature, access to independent early scientific advice would allow manufacturers to address potential hurdles to approval early in the development process, resulting in more efficient innovation and faster patient access to the latest technology. Read more...

Governance

The governance and implementation of the system stands on two pillars: the Member States, through their national Competent Authorities for Medical Devices and the European Commission, through the Directorate for Health and Consumers, DG SANCO. Read more...

Funding

Manufacturers fund the regulatory system in different ways across Europe.  Based on national budgetary policy each Member State takes its own approach in levying fees on manufacturers to fund their regulatory bodies. Read more...

Transition period

It is important for all healthcare stakeholders that the transition from the current regulatory framework (outlined in the Medical Devices Directives) to the new Medical Devices Regulation is a smooth one. To avoid potentially negative consequences, measures must be taken to ensure that patients, doctors and manufacturers understand which legal requirements apply at which point in time. Read more...

Hazardous substances

Medical devices are constructed of many materials and substances. Some substances, which are in other fields considered “hazardous” are necessary for use in medical devices as they have proven net benefits for health. For example, Phthalates such as DEHP are mainly used in medical devices to help replace natural rubber and glass to eliminate kinked tubing and reduce personal injury. DEHP used in blood bags has preservative properties for red blood cells hence prolonging the life of the blood itself. In instances where these substances are used, safety data must be supported by a risk/benefit assessment, which includes the evaluation of alternatives. Read more...

Delegated and implementing acts

As a result of changes under the Treaty of Lisbon, the Commission may adopt delegated and implementing acts to address many important aspects of the Medical Device Regulation after the conclusion of the ordinary legislative procedure. Read more...