April 6, 2020

In response to the Covid-19 emergency, the European Commission released a proposal to amend certain provisions of the Medical Device Regulation (EU) 2017/745. Find out quickly what changes will be made if the proposal is approved by the European Parliament: a decision is expected before the end of May 2020.

Changes to Article 59, “derogation from conformity assessment procedure”

The Proposal, contains the request that Article 59, is systematically applied to personal protection equipment, ventilators and devices needed for the Covid-19 emergency. Article 59 recites: “any competent authority may authorize, on a duly justified request, the placing on the market or putting into service within the territory of the Member State concerned, of a specific device for which the applicable procedures referred to in those Articles have not been carried out but the use of which is in the interest of public health or patient safety or health”.

Therefore, the Authorities of each Member State will be managing the market authorization of these devices. Each country will need to create special legislation and dedicate resources to the verification and approval of these essential devices. Authorization granted under Article 59 can be considered a “waiver from the CE mark process”.


Delay of MDR: spot the new dates in the affected articles

The proposed delay of the MDR application for one year, with a new deadline set on 26 March 2021, will grant extra time to prepare and take the pressure off national authorities, notified bodies, manufacturers and other actors so they can focus fully on urgent priorities related to the coronavirus crisis. In addition, devices lawfully placed on the market pursuant to Directives 90/385/EEC and 93/42/EEC prior to 26 May 2021, may continue to be made available on the market or put into service until 26 May 2025. This is intended to guarantee the continued availability of products and avoid the expected withdrawal from the market of many products due to a lack of MDR readiness.

Meditrial Compliance Program for Covid-19 Devices

Meditrial, a specialized company with top expertise in regulations and compliance for medical devices, is able to immediately support companies dedicated to the production of devices needed to fight COVID-19.

Meditrial’s Compliance Program has three phases:

Phase 1. QUICK EVALUATION – Starting with a training session we provide on what requirements apply in your target country, Meditrial will quickly check what you have and what you are missing

Phase 2. COMPLETE VALIDATION – Meditrial will provide turnkey support to prepare everything you need including Technical Files and Quality System. Speed and high quality are guaranteed thanks to the use of validated templates. We also help you find labs for testing thanks to our close relationships with a network of certified labs.

Phase 3. MARKET AUTHORIZATION – Meditrial experts will help you with submission to the Authority in the target country, and will support responses to questions from the Authority until you get market authorization

Contact us to learn more: intouch@meditrial.net

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