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MedDevice Online

 •  February 6

The new Medical Device Regulation (MDR) was finally published in the Official Journal of the European Union on May 5 last year. The regulation replaces both the previous Medical Device Directive (93/42/ EEC) and the Active Implantable Medical Device Directive (90/385/EEC), with its intention being to set out a new, transparent and sustainable...

MedDevice Online

 •  January 31

Today FDA sent out an alert about Vyaire Medical recalling its AirLife Humidification Chamber and Heated Breathing Circuit Kits. The Class I recall is a result of a manufacturing error that could cause chamber parts to split apart into layers. This can enable water to overflow the chamber and back up into the patient breathing circuit, potentially...

MedDevice Online

 •  January 26

The new Europe (EU) Medical Device Regulations (MDR) published by the European Commission on May 5, 2017 revamped major portions of the EU Medical Device Directive (MDD), raising compliance bars for all device manufacturers, economic operators and notified bodies. The new regulations show a way forward towards the globalization of medical device...

MedDevice Online

 •  January 23

Chronic diseases, also known as non-communicable diseases, are responsible for approximately 70% of all deaths globally, according to the World Health Organization. The four main categories of chronic diseases are cardiovascular disease, cancer, respiratory diseases and diabetes. When these chronic diseases become severe, they are expensive to...

MedDevice Online

 •  January 22

FDA has released information related to concerns over whether the Zoll Medical’s LifeVest 4000 device will fail to deliver treatment. According to a safety alert via MedWatch, if the LifeVest is not replaced soon after it displays “Call for service: Device has a problem that may require service. Call ZOLL for service, Message Code 102.”, the...

MedDevice Online

 •  January 14

Last week FDA issued a warning letter to Becton Dickinson after finding several violations of law following an agency inspection of the company’s facility in New Jersey. The violations include marketing “significantly modified versions of certain BD Vacutainer blood collection tubes without required FDA clearance or approval and failing to submit...

MedDevice Online

 •  January 12

The medical device industry did not ring in the New Year with good news. Just a month ago, the industry thought it was close to yet another suspension, but instead, the infamous device tax went back into effect on January 1 following a two-year suspension. As a result of the tax reform bill that passed last month, medical device manufacturers will...

MedDevice Online

 •  January 6

The European Court of Justice (ECJ) has just made its decision in the case C329/16 SNITEM & Philips France vs. Health Minister, and endorsed the conclusions of the Advocate General. The ECJ holds that a prescription support software (LAP) constitutes a medical device within the meaning of Directive 93/42 when one of the functionalities of this...

MedDevice Online

 •  December 27, 2017

FDA’s Office of Regulatory Affairs has released the most frequently cited inspectional observations for fiscal year 2017. Lack of or inadequate procedures related to DHRs, calibration and inspection, process control, quality audits and design changes were high up on the list. “These observations, are listed on an FDA Form 483 when, in an...

MedDevice Online

 •  December 21, 2017

Last week CDRH posted a list of the guidance documents it plans to issue in FY 2018. Prioritized by an A and B list, final guidance priorities include a UDI policy regarding compliance dates of Class I and unclassified devices, and appropriate use of voluntary consensus standards in premarket submissions for medical devices. Draft guidance...