What are MEDDEV documents?

What are MEDDEV documents?

MEDDEV stands for MEDical DEVices Documents. The MEDDEV Guidance Documents are developed by various working groups on behalf of the European Commission to assist stakeholders in implementing directives related to medical devices.

What are MDR documents?

The main purpose of technical documentation in the EU Medical Device Regulation (MDR) is to prove that a medical device meets the general safety and performance requirements. Regardless of the class, technical documentation is mandatory for all medical devices.

Is PMCF required under MDD?

PMCF is generally required for all products. However, it is possible to justify non-application during the clinical evaluation. This justification depends on the type of device, the intended purpose and the risk class and must explain in a meaningful way why PMCF is not necessary.

Does MDR replace MEDDEV?

In the course of the transition from MDD 93/42/EEC to the new MDR 2017/745, the old MEDDEV documents that applied under the MDD are gradually being replaced by MDCG guidance documents under the MDR and IVDR. Although these guidance documents are not legally binding, they are advised to be considered and implemented.

What is European MDR?

The European Medical Device Regulation (MDR) is a new set of regulations that governs the production and distribution of medical devices in Europe, and compliance with the regulation is mandatory for medical device companies that want to sell their products in the European marketplace.

Is PMCF required?

While regulators do not require a PMCF study for every device, manufacturers who believe their device does not need one must include their rationale in their technical documentation. In summary, risk and novelty are the primary criteria that drive the need for PMCF study.

Is PMCF required for Class 1?

There is a new safety reporting requirement for all devices (except class I) called the Periodic Safety Update Report, PSUR. According to the regulation, the PSUR is based on the PMCF, so in theory a PMCF would be required for all of these classes of device.

What are the new EU MDR requirements?

The new MDR includes a mandate for Unique Device Identification (UDI) that is intended to facilitate the traceability of all medical devices sold in the region. Devices must be marked with a device identifier (DI) and each batch or production series of the product will be marked with a production identifier (PI).

How do you convert MDD to MDR?

Checklist: What should you do to prepare?

1. Schedule your first MDR audit. After the first MDR audit and the assessment of product documentation, it takes at least another 12 months before a new MDR certificate can be issued.
2. Check the validity date of your current MDD certificate.
3. Plan for your transition.

Are there any EU directives on medical devices?

The following medical devices Directives are currently applicable within the EU 1998: Directive 98/79/EC of the European Parliament and of the Council on In Vitro Diagnostic Medical Devices (IVDMD) 1993: Council Directive 93/42/EEC on Medical Devices (MDD) 1990: Council Directive 90/385/EEC on Active Implantable Medical Devices (AIMDD)

How does the European medical device vigilance system work?

In addition, the Medical Device Vigilance System aims at preventing the repetition of incidents related to the use of a medical device. For that, European Databank on Medical Devices (Eudamed2) provides national competent authorities with fast access to information. It also contributes to a uniform application of the Directives.

Who are the stakeholders in the meddevs directive?

The MEDDEVs are drafted by authorities charged with safeguarding public health in conjunction with all stakeholders (industry associations, health professionals associations, notified bodies and European standardisation organisations). This is in accordance with the relevant annexes of the directives

How does European databank on medical devices work?

For that, European Databank on Medical Devices (Eudamed2) provides national competent authorities with fast access to information. It also contributes to a uniform application of the Directives. See more via the Market Surveillance and Vigilance page.