Archive for the ‘Standards’ Category

Pan-European Patent Proposal Could Be Approved Next Month

Tuesday, November 27th, 2012

After over 30 years of attempts, the European Union is close to reaching a compromise on a pan-European patent. Well, sort of. The current unified patent proposal covers 25 of 27 member states, since Spain and Italy are not participating. The working group of the Council of the European Union agreed ...

New International Standard Assures Consistent and Proper Labelling of Medical Devices

Wednesday, July 25th, 2012

The British Standards Institution BSI has published a new international standard to promote global consistency and help drive innovation in the labelling of medical devices. The BS EN ISO 15223-1 supersedes the well-respected European standard, BS EN 980:2008, which will consequently be withdrawn on 31 January 2013. The publication of ...

EngineerING Card Could Increase Mobility of European Engineers

Wednesday, December 7th, 2011

[caption id="attachment_26104" align="alignleft" width="218" caption="A German engineerING card"][/caption] While the open borders in the European Union have made it easier for Europeans to travel to and work in other countries, professionals who look for a job abroad often find that entering the job market in another country is a lot more ...

EMDT Poll Shows Strong Support for Notified Bodies Code of Conduct

Tuesday, August 23rd, 2011

Earlier this month, a group of EU medical device Notified Bodies signed a voluntary Code of Conduct designed to improve the consistency and competency of uniform bodies. The code was endorsed by the members of the Association of Notified Bodies (TEAM-NB) in April of this year. The group of Notified Bodies ...

New ISO 14155:2011 Standard Safeguards Patients

Tuesday, May 10th, 2011

A new ISO international standard is designed to ensure patient safety during clinical investigations without erecting obtrusive barriers to trade. ISO 14155:2011, Clinical investigation of medical devices for human subjects – Good clinical practice, addresses the design, conduct, recording and reporting of clinical investigations carried out on human subjects to ...

NICE Publishes New Guidelines for the MTEP Process and Methods

Friday, April 22nd, 2011

The National Institute for Health and Clinical Excellence (NICE) in the United Kingdom has released guides to the Medical Technologies Evaluation Programme (MTEP) process and methods. The MTEP selects and evaluates new medical technologies and aims to speed up the process of introducing their use in hospitals. The programme launched ...

Sweden Formally Objects to EN ISO 13485:2003

Thursday, February 17th, 2011

On 10 February 2011, Sweden formally objected to the harmonised standard, "Medical devices – Quality management systems – Requirements for regulatory purposes" (EN ISO 13485:2003), says Eucomed. Eucomed favours clear standards that avoid differences in interpretation and implementation of law by EU member states. Some of the technical and legal technicalities ...

A Squabble over Standards

Wednesday, February 16th, 2011

"Jacqueline Minor, director of consumer affairs at the European Commission, with oversight for medical devices, met [on 10 February] with Elena Santiago Cid, director general of the European standards committees, CEN and CENELEC, to discuss the matter of the commission’s Formal Objections against the 11 European medical device standards,” reports ...

Design Smarter Medical Products

Friday, January 21st, 2011

A pair of white papers from IBM Rational can help you design smarter medical products. This is essential when you’re talking about life-critical products, such as cardiac support devices, patient ventilators and drug infusion pumps. IBM has developed a proven design methodology that offers integrated and collaborative capabilities, based on the ...

German Battery Manufacturer Offers IEC 60601-1-Compliant Product Line

Monday, December 20th, 2010

On 1 June 2012, the 3rd edition of the IEC standard 60601-1 for medical electrical devices will replace the 2nd edition. From that date on, all medical devices can only be sold in the EU if they are designed, validated and verified according to this specific standard. RRC power solutions, ...

UL Publishes IEC 60601 FAQs

Thursday, November 25th, 2010

If you've got questions about IEC 60601 3rd edition, then Underwriters Laboratories (UL) may have the answers. The global product safety testing and certification body has announced the publication of more than 70 FAQs related to the standard, which includes the latest revisions to the internationally harmonised safety standard for electromedical ...

CEN-CENELEC Website Sets New Standard for Working with SMEs

Sunday, November 7th, 2010

The European Committee for Standardization (CEN) and European Committee for Electrotechnical Standardization (CENELEC) have joined together to reach out to small and medium-sized enterprises (SMEs) and make it easier for them to engage in standards-related activities. The most recent manifestation of this initiative is the launch of the CEN-CENELEC SME web ...