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Are MEDDEV documents still valid?

With the replacement of the EU directives MDD, AIMDD, and IVDD by the EU regulations MDR and IVDR, the MEDDEV documents are largely obsolete. One exception is, for example, the MEDDEV 2.7/1 rev 4 guideline. Manufacturers and notified bodies should, therefore, always check whether there is a suitable MDCG guideline.

What is a MDR equivalent device?

Understanding Equivalence under the MDR Claiming equivalence is demonstrating that your medical device is equivalent to an already legally marketed device in terms of clinical, technical, and biological characteristics.

What is MDR in medical devices?

Mandatory Medical Device Reporting Requirements The Medical Device Reporting (MDR) regulation (21 CFR Part 803) contains mandatory requirements for manufacturers, importers, and device user facilities to report certain device-related adverse events and product problems to the FDA.

What is the MDR Annex 14 Part A?

The MDR (Annex XIV, Part A) establishes that, in order to demonstrate equivalence in relation to other devices, three characteristics must be considered when demonstrating equivalence: technical, biological, and clinical. These characteristics shall be investigated and differences between devices should be disclosed.

What is a similar device MDR?

Understanding similar devices In simpler words, any device can serve as a similar device if it has a similar or the same intended purpose OR is based on a common technology without exhaustive demonstration of technical, biological, and clinical characteristics, which are obligatory to claim equivalence.

What are the MDR device categories?

Essentially, all devices fall into four basic categories: Non-invasive devices. Invasive medical devices. Active medical devices. Special Rules (including contraceptive, disinfectant, and radiological diagnostic medical devices)

What is the difference between MEDDEV and Mdcg?

MEDDEV guidance documents, like 2.7/1 Rev. 4, are aligned with the old Medical Device Directive (MDD) and Active Implantable Medical Device Directive (AIMDD). MDCG guidance documents, on the other hand, are aligned with the new EU Medical Device Regulations (MDR).

What does MDR mean equipment?

Medical Device Regulation. The European Medical Device Regulation (MDR) replaced the MDD and the AIMDD and entered into force on 25 May 2017 with 26 May 2021 as date of application.

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