Obelis SA OBELIS GROUP of Brussels at MEDICA 2022 in Düsseldorf -- MEDICA - World Forum for Medicine
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Company news

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25 Aug 2022

Watch our webinar: IVDR vs IvDO | How IVDs are regulated on the EU & CH markets

Are you seeking information on In - Vitro Diagnostics Medical Devices concerning the EU & CH markets? It can be quite challenging to navigate the regulatory maze of product regulation. For this reason, Obelis is here to help!

In this Webinar, Obelis offers you guidance from a professional regulatory expert that will lead you through the following topics:

  • Overview of IVD regulatory framework in CH and EU
  • What shall a non-Swiss company do to sell its devices in Switzerland?
  • What are the requirements for a Swiss company selling in the EU? 
  • Recommendations to manufacturers
REGISTER NOW!

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25 Aug 2022

Obligation on icons and symbols to display for manufacturers of medical devices

Labels and instructions for use (IFUs) of medical devices must comply with Medical Devices Regulation and IVD Medical Devices Regulation. Based on intended use, mode of operation, and other characteristics, medical devices must include certain icons and symbols either on the labels or in the IFUs, or both. It is important to note that information on medical devices must be in a format correctly understood by every stakeholder in the supply chain of the device.

How are standards developed?

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25 Aug 2022

Class I Medical Devices: Achieve MDR compliance in 9 steps

Classifying a medical device under Regulation 2017/745 (MDR) means considering its intended purpose and inherent risks. Like under the old Directive, Class I devices present a low risk to patients and end users. However, the new Regulation has introduced more rules, leading to some devices being upgraded to Class IIa, IIb, or even III.

To help Class I manufacturers comply with the new regulation by May 26, the European Commission (2021) has released a useful factsheet. The document shows the necessary steps for compliance in a more immediate and user-friendly way, by summarising the MDCG guidance on the same topic (MDCG 2019-15 rev. 1, 2020).

What are the nine steps towards MDR compliance?

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25 Aug 2022

The future regulations of medical devices in the United Kingdom

Following Brexit, many changes have been introduced to how medical and in vitro diagnostic devices are placed on the market in Great Britain. At present, the changes involve secondary legislation. The manufacturers can choose to comply with the MD 93/42/EEC, EU MDR 2017/745, or UK MDR 2002 to place devices on the UK market until July 1, 2023.

To improve how medical and in vitro diagnostic devices are regulated in the UK, the Medical Devices Regulations 2002 will soon be amended. For this reason, between September and November 2021, the Medicines and Healthcare products Regulatory Agency (MHRA) consulted on proposed changes to the future medical device regulatory framework, which aims towards:

  • improved patient and public safety, greater transparency of regulatory decision-making, and medical device information
  • close alignment with international best practices, and
  • more flexible, responsive, and proportionate regulation of medical devices.
The consultation involved responses from 413 individuals and 451 organisations. Considering the responders’ answers, the government responded to all the proposals, summarised in the report from June 26, 2022.

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24 Aug 2022

Webinar: EUDAMED Challenges: Actor & Device Registration

Topics we will be covering:

  • What is EUDAMED
  • Module: Actor Registration for a non-EU based manufacturer
  • EUDAMED & PRRC
  • Module: UDI/Device Registration
  • EUDAMED Timelines
  • Services

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11 Aug 2022

MOST FREQUENTLY ASKED QUESTIONS ON IVDR

This document has been conceived for in-vitro diagnostic manufacturers to provide information on the impact of the new IVDR.

  • Which devices can be sold as legacy devices under IVDR after May 26, 2022?
  • Can I sell IVDR-compliant devices before the date of application (DoA) of IVDR?
  • Can I sell devices after the IVDR DoA?
  • How is covid testing regulated under IVDR – Regulation (EU) 2017/746?
  • What is the “sell-off” provision about?
  • What are the obligations of the manufacturer under IVDR?

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10 Aug 2022

Expired certificate in the UK: implication and actions to take

To sell medical devices on the UK market, the manufacturer shall register their medical devices with the UK competent authority (MHRA). To successfully complete the registration process, manufacturers must provide, among other documents, a copy of any conformity assessment certificates or self-certification conformity declarations, as applicable.

Do not forget that these certificates have an expiration date!

Are you a Medical Device manufacturer wishing to market your devices on the UK market?
Contact Obelis UK, your UK Responsible Person, today: --> https://www.obelis.co.uk/contact/get-in-touch/

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