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Good News For Commercial Reprocessors In Commission’s Draft Implementing Act On SUDs

 
• By Amanda Maxwell

Reprocessing is not going to be easy for hospitals in-house, putting the likely market into the hands of commercial reprocessors. What do we know about how the outlook is shaping up from the draft Commission Implementing Regulation, an implementing act now moving well down the pipeline?

Lab_Cleaning

Most EU hospitals are not equipped to comply with level of stringency demanded in the draft European Commission Implementing Regulation that lays down rules for the application of the EU Medical Devices Regulation as regards common specifications for the reprocessing of single-use devices. 

That is the view of Dan Vukelich, president of the Association of Medical Device Reprocessors (AMDR), based in Washington, DC.

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More from Europe

Time For Medtech To Have Its Say On Critical Changes In EU Framework Legislation

 
• By Amanda Maxwell

In revising the foundations of EU product legislation, the European Commission aims to increase harmonization, cut regulatory burdens and promote digital tools to boost compliance and safety.

Bates To Energize UK Office For Life Sciences

 
• By Ashley Yeo

Steve Bates, head of the UK BioIndustry Association, has been appointed executive chair of the government’s Office for Life Sciences as the UK restructures its life sciences approach and drives health outcomes with a new NHS Long-Term Care plan.

International Reliance Gets UK MHRA OK In Drive For Agile Pre-Market Regulation – CE Marking Next

 
• By Ashley Yeo

The UK government’s response to MHRA public consultation on risk proportionate device routes to market and physical UKCA markings adds momentum to drive for modern, agile system. Another consultation in late 2025 will propose indefinite recognition of CE-marked devices in Great Britain.

Expert Panels Remain Tough On Manufacturers And Their Notified Bodies

 
• By Amanda Maxwell

The EU’s extra layer of checks on clinical evidence is proving a difficult, and sometimes humiliating process, for many device companies whose products have come under the spotlight.

More from Geography

Time For Medtech To Have Its Say On Critical Changes In EU Framework Legislation

 
• By Amanda Maxwell

In revising the foundations of EU product legislation, the European Commission aims to increase harmonization, cut regulatory burdens and promote digital tools to boost compliance and safety.

Medtech M&A Resurges: How To Define Startup Exit Strategy

 
• By Natasha Barrow

The medtech M&A landscape is experiencing a resurgence fueled by significant capital from private equity and venture firms, says Alex Wakefield, CRO of AcuityMD. Building strong relationships with physicians remains crucial in medtech, and defining an exit strategy early is imperative.

HHS Suggests Drastic Reductions To Skin Substitute Payments

 
• By Elizabeth Orr

The US Department of Health and Human Services has proposed cutting Medicare reimbursement for skin substitutes used in chronic wound care by up to 90%. The change aims to address rising costs but could harm patient access and treatment quality, prompting concerns from industry stakeholders.