CE Check - Digital CE Marking

Manufacturers of DRUG-DEVICE combination products should read this article 👉 https://buff.ly/32mpvQe ❕❗️

It focuses on:
➡️ what they need to know to achieve EU MDR compliance
➡️ the challenges they could face and how to overcome them.

The new EU MDR and its impact on drug device combination products This article discusses the key elements of the EU MDR pertaining to drug device combination products and how life science companies can organize themselves to ensure regulatory compliance is met. The author will work through what manufacturers of these types of devices need to know in order to achie...

The MDCG has published 28-page 📑 aimed at clarifying which types of will be regulated under the new and rules and how they ought to be classified and placed on the market.

Read more on the topic 👉https://buff.ly/34x27B6
Download the guidance 👉 https://buff.ly/2oJRdZx

Medical software makers get new guidance on MDR, IVDR The European Commission's Medical Device Coordination Group aims to clarify which software will be subject to the new regulations, and how those products should be classified and placed on the market.

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The European Commission has published that provide a step by step overview on how to assess the use of by conducting a benefit-risk assessment. Competent and will consider these Guidelines as the state of the art guidance concerning the use of phthalates in .

Read more here ➡️ https://buff.ly/2p153X9
Access the document ➡️ https://buff.ly/339LVoL

The European Commission has published Guidelines concerning the use of phthalates in medical devices | Focus on Regulation The European Commission's Scientific Committee on Health, Environmental and Emerging Risks (SCHEER) has published Guidelines concerning the use of