MEDICAL DEVICE MAKERS based in Ireland are ramping up their recruitment measures to meet stringent new EU regulations that are just months away. US manufacturer Cook Medical is hiring 20 new full-time roles in its Limerick base, which is largely responsible for compliance with the EU’s Medical Device Regulation (MDR). “These roles are part of a larger recruitment drive globally, specific to the EU MDR,” Sinead Burke, director of regulatory affairs at Cook Medical Europe, told Fora. “We have also taken on over 70 new contract roles globally to help with the implementation of EU MDR.” The MDR is a set of new rules passed by European lawmakers in 2017 that will introduce much stricter clinical reporting and post-market surveillance responsibilities for device makers. Recruitment at Cook Medical is mostly around roles in regulatory affairs and engineering to meet this new system. Burke explained that “key changes within the regulations required us to invest in these new roles” to put more emphasis on clinical and post-market clinical follow up procedures. She said the regulation change will have a “big impact” on all six of Cook Medical’s manufacturing sites worldwide. “(It) will integrally change the way we work in a lot of key areas of our business, but we are fully committed to making sure we are compliant and embrace this new legislation as a positive step.” Medical device giant Stryker is also carrying out a similar strategy. The firm, which employs more than 3,500 people in Ireland, is recruiting engineers and project managers at its Cork plant specifically for MDR work. Medtronic, the world’s largest medical device maker that is formally headquartered in Dublin, declined to comment on its recruitment efforts, but a spokesperson said it has “created a comprehensive implementation plan to transition our products to the new regulation”. … Read More
The United Kingdom government has proposed relaxing the regulatory requirements on the lowest risk clinical trials after it leaves the European Union. Officials made the proposal in a suite of changes intended to make the UK a leading location for life sciences companies after Brexit. Full details of the Medicines and Medical Devices Bill are yet to emerge, but the government sketched out the main benefits and elements in a briefing document this week.
Brussels – 24 September 2013 Today, the European Commission published a recommendation on the audits and assessments performed by notified bodies in the field of medical devices. The Recommendation provides general guidelines for product assessments, quality system assessments and unannounced audits. The guidelines do not include new rights or obligations, but aim to ensure that notified bodies carry out a proper verification of the fulfilment of the legal requirements by the manufacturer.
On Friday 27 April 2012, the European Commission published updated lists of the European harmonized standards that pertain to the Medical Devices Directive (93/42/EC), In Vitro Diagnostics Directive (98/79/EC), and the Active Implantable Medical Devices Directive (90/385/EEC). The standards on these lists may be used by manufacturers to prove that their equipment complies with the essential requirements of this directive. The updated list are important to all manufacturers of CE marked medical devices, active implantable medical devices and in vitro diagnostics that have used European harmonized standards to prove CE compliance. If you have applied standards to prove compliance with the aforementioned directives, re-evaluate your products against the updated standards and update your Declaration of Conformity.
The European Commission has referred Greece back to the EU’s Court of Justice because of its failure to apply EU rules on public procurement as regards contracts for supplies of medical equipment to hospitals. In the Commission’s view, Greece continues to infringe EU law and has not complied with a Court judgment of 19th March 2009 (C-489/06).
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