spacer
home > news > detailed info
INDUSTRY NEWS AND PRESS RELEASES

Regulatory bottlenecks mean EU clinicians and patients could lose access to medical devices under new rules

ICON plc

ICON to present at The Medtech Conference 2019 on what companies need to know as Europe faces stringent new medical device regulation

European clinicians and their patients could lose access to vital medical devices, including in-vitro diagnostics, due to a lack of agencies able to certify products in time to comply with strict new regulations.

A particular concern is in-vitro diagnostic devices (IVDs), used to perform tests on samples such as blood, urine and tissue. Whereas only about 7 per cent of in vitro diagnostic devices required clinical evidence for approval under existing EU IVD directives (IVDD), 85 per cent will now need it under IVDR, an increase of almost 80 per cent.

All 500,000 existing medical devices currently on the EU market must be recertified under new Medical Device Regulations (MDR). There is significant concern that tight deadlines and the lack of notified bodies (NB) may result in devices not being recertified.

So far, only 2 of 58 existing notified bodies (NBs) have been designated to operate under the European Union’s MDR and zero for IVDR, causing a regulatory bottleneck. With one NB located in the United Kingdom, BSI-UK, its status is uncertain in the face of Brexit; although, they have established an office in the Netherlands (BSI-UK) where Dutch authorities indicate transitioning designation out of the UK should be seamless.

About 80 percent of NBs operating under existing EU medical device directives had applied for MDR by December 2018, but the certification process is complex, and only a handful are anticipated to be designated this year.

An expert from leading clinical research company ICON plc will join a panel discussion ‘MDR/IVDR - What Now?’ at The Medtech Conference (September 23-25) in Boston, where they will discuss the findings of ICON’s a white paper ‘Higher Costs and Bottlenecks’.

The paper outlines steps medical device and in vitro diagnostic developers must address to maintain market share and in the longer term, develop and maintain financially viable product portfolios.

These include:
1. Overcoming the growing shortage of NBs
2. Addressing new clinical data requirements under MDR and IVDR
3. Developing a global market entry strategy to capitalize on opportunities
4. Considering launching new products in the US and other countries
5. Involving top management in compliance efforts

Will you be attending The Medtech Conference 2019 (September 23-25) in Boston?

ICON’s panel discussion session, ‘MDR/IVDR - What Now?, is on September 24 at 3.45 PM ET (Room 156 AB). If you would like to interview an ICON spokesperson, either by phone or at the conference, we will be happy to make arrangements.
phone +353 1 291 2883
email info-clinical@iconplc.com
web www.iconplc.com
email ICON plc, Headquarters, South County Business Park, Leopardstown, Dublin 18, Ireland
 
Print this page
Send to a friend
   
spacer
News and Press Releases

Signant Health invests for growth with the opening of its new Philadelphia-area office

PHILADELPHIA, PA – February 18, 2020: Signant Health, an industry-leading clinical research technology and solutions company, is proud to announce that it has officially opened a new, leading edge office facility in Blue Bell, Pennsylvania. Construction on the new office, which is the largest workplace in Signant Health’s global network, completed in February 2020.
More info >>


White Papers

Syringe siliconization

Gerresheimer AG

Ready-to-fill, i.e. sterile, prefillable glass syringes, are washed, siliconized, sterilized and packaged by the primary packaging manufacturer. They can then be filled by the pharmaceutical companies without any further processing. These days the majority of prefillable syringes are made of glass and the trend looks set to continue. The siliconization of the syringe barrel is an extremely important aspect of the production of sterile, prefillable glass syringes because the functional interaction of the glass barrel siliconization and the plunger stopper siliconization is crucial to the efficiency of the entire system. Both inadequate and excessive siliconization can cause problems in this connection. The use of modern technology can achieve an extremely uniform distribution of silicone oil in glass syringes with reduced quantities of silicone oil. Another option for minimizing the amount of free silicone oil in a syringe is the thermal fixation of the silicone oil on the glass surface in a process called baked-on siliconization. Plastic-based silicone oil-free or low-silicone oil prefillable syringe systems are a relatively new development. Silicone oil-free lubricant coatings for syringes are also currently in the development phase.
More info >>

Industry Events

World Vaccine Congress Europe

18-21 October 2020, Barcelona, Spain

The World Vaccine Congress is an award-winning series of conferences and exhibitions that have grown to become the largest and most established vaccine meeting of its kind across the globe. Our credibility is show through the prestigious scientific advisory board that spend months of hard work creating a new and topical agenda, year on year.
More info >>

 
©2000-2011 Samedan Ltd.
Add to favourites

Print this page

Send to a friend
Privacy statement