EU MDR Archives - Medical Design Sourcing

Butterfly Network wins CE mark for IQ+ handheld ultrasound tech, hopes for next-gen nod this year

The IQ+ system [Image courtesy of Butterfly Network]Butterfly Network (NYSE:BFLY) announced today that it garnered CE mark approval for its Butterfly iQ+ ultrasound system.

The company obtained European Union Medical Device Regulation (EU MDR) certification for the iQ+ system. It initially received CE mark in 2021, but had to fall in line with updated, more stringent regulations in Europe.

According to a news release, the additional certification allows Butterfly Network to release important new features to all existing and prospective European customers. That includes its pulse wave doppler (PWD) in presets and its AI-enabled auto B-line counter. Butterfly expects to roll out these additional functionalities within the second quarter of 2024.

The new feature release spans Europe, including Austria, Belgium, Denmark, Finland, France, Germany, Ireland, Italy, the Netherlands, Norway, Poland, Portugal, Spain, Sweden, Switzerland, and the UK. Butterfly iQ+ can…

Alarming results and some good news from MDR and IVDR survey of notified bodies

[Image via Adobe Stock]

By Annette Van Raamsdonk and Evangeline Loh, Emergo by UL

The European Commission (EC) posted a July 25 update on the current state of Medical Devices Regulation (2017/745 MDR) and In Vitro Diagnostics Devices Regulation (2017/746 IVDR) applications.

The data collected was from a recent survey instrument intended to monitor and analyze the availability of devices on the EU market.

Study on medical devices and Notified Body survey instrument

The study was led by Gesundheit Österreich GmbH (Austrian National Public Health Institute) with Areté and Civic Consulting. The study started in December 2022 and will end in 2025.

The survey instrument to collect the most recent data on certificates issued and the number of applications received was shared with the Notified Bodies on April 3, 2023, and concluded May 5, 2023.

The collected data have been compared with data…

Confluent Medical now offers EU MDR-compliant polyimide tubing

[Image courtesy of Confluent Medical]

Confluent Medical Technologies announced today that it now offers REACH and EU MDR-compliant polyimide tubing.

REACH, a European Union regulation, imposes stringent limitations for the EU market. It covers the amount of restricted substances contained in devices sold in the EU. It stands for Registration, Evaluation, Authorization, and Restriction of Chemicals. The industry-standard polyimide contains one of the restricted solvents. Common uses for polyimide include medical applications such as vascular catheters.

Confluent Medical said its REACH-compliant material uses industry-standard chemistry. It results in a product that looks and performs like traditional polyimide. However, it avoid the historical hurdles that need clearing to ensure EU compliance.

The company said it plans to offer the REACH-compliant polyimide immediately with lead times of four week…

MDR reportedly causing medtech companies to leave EU market

The EU’s new Medical Devices Regulation (MDR) has created enough compliance costs that some medtech companies have stopped selling there., according to a report from Reuters.

Reuters spoke with eight companies, including the Swedish medtech giant Getinge, who are either withdrawing from the EU market or have stopped making medical devices. The costs of complying with the MDR were simply too much.

The EU’s MDR went into effect in 2021. Medical device makers have had until 2024 to transition previously certified devices to the new standard.

Reuters reports that European doctors’ groups are already reporting medical equipment shortages. The Russia-Ukraine war has caused material shortages that have further exacerbated the problem.

EU leaders have become aware of the problems. The EU Health Commissioner Stella Kyriakides has proposed extending the transition deadline to 2027 for high-risk devices — 2028 for medium- and low-risk produ…

The top 10 medtech regulatory stories of 2022

[Image from Unsplash]There was plenty of news from the FDA, but the medtech regulatory story that got the most attention from MassDevice readers was out of Europe.

Here are the top medtech regulatory stories on MassDevice and Medical Design & Outsourcing in 2022:

10. Philips’ respiratory devices recall has even more problems

It’s one of the most serious recalls that the medical device industry has ever seen, involving millions of devices. The situation became even worse in November when Philips announced some ventilators reworked as part of the recall had new problems.

9. FDA proposes major changes to medical device quality regulation

The goal is for U.S. medical device quality regulation to better align with regulations worldwide.

8. Has the CE mark lost its appeal for novel medical device developers?

Medtech companies are increasingly looking to the FDA instead of Europe’s CE mark when launching novel products, according to a report publi…

Report: European Commission proposes to delay EU MDR deadline until 2028

Stella Kyriakides announced a plan to delay deadlines for EU MDR. [Image from Pietro Naj-Oleari/Wikimedia Commons]The European Union’s Health Commissioner today proposed pushing back the deadline for its new medical device regulation (MDR) law.

Reuters first reported the news yesterday and confirmed it today. Commissioner Stella Kyriakides proposed a delay for the deadline for companies to comply from 2024 to as late as 2028. According to the report, this comes because of a need to “prevent shortages of lifesaving equipment.”

The report noted that pushback from doctors’ associations and trade groups presented warnings around EU MDR implementation. The regulations came into effect in 2021. This change replaced the EU Medical Device Directive (MDD) with more stringent requirements on the companies that perform the audits for each device.

The change affects not only devices that are new to the EU market but those that entered the market…

Navigating MDR’s newly charted waters

Compliance with the EU’s MDR often requires multidisciplinary collaboration between a device maker’s operations, R&D, regulatory and quality teams, plus partners across the supply chain. [Photo courtesy of Avery Dennison Medical]

With the Medical Device Regulation in effect, European Union regulatory compliance requires rigorous attention and cross-functional collaboration.

Lisa Bartakovics, Avery Dennison Medical

Are you ready for MDR? That question has weighed on medical device manufacturers ever since the European Union proposed stronger device regulations and requirements.

After MDR became law in May 2017, the industry had four years to transition and comply. It’s been more than a year since MDR’s May 26, 2021, application date, yet there still is uncertainty regarding compliance requirements due to the lack of guidance documents and individual interpretation.

O…

MedTech Europe warns on ongoing regulatory issues

MedTech Europe welcomed the first wave of new E.U. medical device regulations this week, but said there’s work that’s yet to be done.

The trade group noted that EU MDR — the new regulatory regime for medical devices — strengthens the system of notified bodies, or companies that conduct audits on each device whose manufacturer is seeking entry to the E.U. market. It also provides a new database to enable more transparency, a unique device identification system to assist with supply chain traceability, and stricter clinical evidence requirements. EU MDR replaces the EU Medical Device Directive (MDD), with today ending the first phase of implementation.

Get the full story on our sister site, Medical Design & Outsourcing.

EU MDR finally goes into effect

The E.U.’s Medical Device Regulation (MDR) takes effect tomorrow, changing the process to gain entry to the continental market.

EU MDR replaces the EU Medical Device Directive (MDD) with more stringent requirements on the companies that perform the audits for each device, also known as notified bodies. The change affects not only devices that are new to the EU market but those that entered the market under MDD and must be re-certified under MDR to remain available for sale — a costly and time-consuming process.

Get the full story on our sister site, Medical Design & Outsourcing.

EU allows remote audits for medical devices during pandemic

The European Union has announced that it will temporarily allow remote audits of medical devices and in vitro diagnostics under the new regulations (MDR IVDR), set to go into effect on May 2021 and 2022 respectively.

In a document published Monday, the European Commission agreed with industry and notified bodies that the ongoing COVID-19 pandemic has made in-person audits at manufacturers’ facilities difficult if not impossible.

Get the full story on our sister site, Medical Design & Outsourcing.