Avoiding MDR Pitfalls On Cybersecurity: How EU Rules Could Catch Manufacturers Out

Interpretation of cybersecurity requirements can be a moot point

Is it clear which medtech products must demonstrate conformity with EU regulations on cybersecurity? Experts weigh in on the case of an alleged discrepancy between a notified body and a manufacturer on this matter.

Disagreement
• Source: Shutterstock

Medtech innovators face many changes to EU medical device rules under the new Medical Device Regulation, but the introduction of cybersecurity requirements is perhaps one of the most notable additions, given that no such safety provisions existed under the former medtech directives.

However, the need to demonstrate that a product is cybersecure, in accordance with Annex I of the MDR and guidance...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Medtech Insight for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from Europe

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

 

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 

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 

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

 

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

 

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

 

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 

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.