Medical Device Regulation (MDR): new guidance documents published

Today, the European Union’s advisory organ for medical devices, the Medical Device Coordination Group (MDCG) published three new guidance documents and revisions to several existing ones. The guidance documents provide information and explanations on specific issues related to the transition from the Medical Devices Directive (93/42/EC) to the Medical Device Regulation (EU) 2017/745 and the In Vitro Diagnostics Directive (98/79/EC) to the In Vitro Regulation (EU) 2017/746. The MDCG provides advice to the Commission and assists the Commission and the Member States in ensuring a harmonised implementation of medical devices Regulations (EU) 2017/745 and 2017/746.     New MDCG guidance documents: MDCG 2020-1: Guidance on Clinical Evaluation (MDR)/Performance Evaluation (IVDR) of Medical Device Software: This guide provides the framework for identifying the appropriate level of clinical evidence required for Medical Device Software (MDSW) to meet the requirements of the MDR. MDCG 2020-2: Class I Transitional provisions under Article 120(3 and 4) – (MDR): This guide describes the relevant information to be included in the manufacturer’s Declaration of Conformity (DoC) under the MDD for Class I (non-sterile/non-measuring) devices that must have MDR certificates after May 24, 2024. MDCG 2020-3: Guidance on significant changes regarding the transitional provision under Article 120 of the MDR with regard to devices covered by certificates according to MDD or AIMDD: This guide specifies what constitutes a “significant changes in design or intended purpose” under Article 120(3) of the MDR. It also states that such changes will no longer be issued new MDD/AIMDD certificates. Also, the device will be prevented from being placed on the market under the MDD/AIMDD after the implementation of the MDR. Finally, the guidance includes decision flowcharts to help manufacturers decide whether or not a change to a device will be considered significant.   Revisions to existing guidances: MDCG 2018-1 v3: Guidance on BASIC … Read More

Medical device makers are on a recruitment drive as strict new EU rules edge closer

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

UK Plans to Loosen Rules on Low-Risk Clinical Trials in Post-Brexit Shakeup

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.

European Commission Publishes Recommendation on the Audits and Assessments Performed by Notified Bodies in the Field of Medical Devices

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.