V O L 3 0 I S S U E 2 / 2 1 J u n e / J u l y 2 0 2 1 T H E E U R O P E A N F O R U M F O R T H O S E I N T H E B U S I N E S S O F M A K I N G H E A L T H C A R E W O R K RADIOLOGY 14-16 Five-minute MRSA detection Intervention and immuno-oncology AI tool improves high volume mammography LABORATORY 8-11 Skin swabs can detect Covid-19 Specimen diversion tools lower blood culture contamination ‘Barcode’ brings quicker test results New regulation has a global impact This May the updated Medical Device Regulation (MDR) was implemented, a year after a delay caused by the coronavirus pandemic. This, the first update in three decades, has implications for the MedTech and healthcare sectors, which was examined by experts during a special MDR conference. Report: Mark Nicholls included Erik Hansson, Speakers Deputy Head of the Unit of the European Commission responsi- ble for the legislation on medi- cal devices. He discussed the challenges and benefits of the regulations from a European perspective and focused on two of the main EC tasks under the new regulation – to develop implementa- tion enactment and guid- ance documents – and the new European Database on Medical Devices (EUDAMED). ‘The new legislation is very ambitious and needs a lot of effort and resourc- es from all actors involved – manufacturers, notified bod- ies, Member States and the Commission – and will have an important impact on relevant stakeholders, such as healthcare providers,’ Hansson explained, speaking with European Hospital ahead of the event. Uniform implementation A series of guidance documents developed by the Medical Device Coordination Group, the EC and stakeholders, will help deliver a uniform implementation of the new regulations across Member States, he added. The MDR aims to bring EU legislation in line with technical advances, changes in medical sci- ence, and progress in law making. ‘They create a robust, transpar- ent, and sustainable regulatory framework, recognised internation- ally, which improves clinical safety and creates fair market access for manufacturers. In contrast to direc- tives, regulations do not need to be transposed into national law. The MDR will therefore reduce the risks of discrepancies in interpretation across the EU market.’ Wide-reaching impact The legislation revision is the first since the EU acts were drawn up 30 years ago, and will have a broad- www.healthcare-in-europe.com Medical Device Regulation r e a c h i n g impact. ‘The legislation will be applied in the EU as well as certain countries with which the EU has agreements and therefore will be applied in not far from half of the countries worldwide that are regu- lating medical devices,’ Hansson pointed out. ‘Therefore, it will also have a global impact.’ to the Compared current Directives, the new regulations emphasise a life-cycle approach to safety, backed up by clinical data and add more stringent rules for the designation of the certification bod- ies and also add more control and monitoring requirements. Greater transparency In terms of the impact on health- care, he said: ‘The main objective is to ensure efficient and safe medi- cal devices for use in healthcare. It will also bring more transparency for healthcare professionals as the new EUDAMED database includes information on devices which will also be accessible for healthcare professionals once final- ised.’ Traceability of devices will also improve through a Unique Device Identifier (UDI) system based on the use of barcodes. Factors that healthcare providers need to consider, Hansson said, should be to make sure that devices are CE-marked, ensuring that the requirements of the legislation are fulfilled. The Regulation contains specific provisions on when health institu- tions can manufacture, modify and use devices ‘on a non-industrial scale’ in-house when equivalent ones are not available commercially. It also clarifies the obligations of manufacturers, authorised repre- sentatives, importers and distribu- tors, and both device and manufac- turer must comply with the MDR. Patient safety Manufacturers need to assess the conformity of a device, while other important points of the MDR include requirements on clinical evaluation, risk management, qual- ity management systems, post-mar- ket surveillance, technical docu- mentation and other reports and liability for defective devices. ‘One of the more important aspects for improving patient safety are the reinforced requirements for clinical evaluation,’ he said. ‘As under the old Directives, it includes the collection of clinical data already avail- able in the literature as well as the setting up of any necessary clinical investi- gations.’ Patient safety is a key aim of the new regula- tions and the strengthened legislation has improved safeguards to achieve this. ‘The overall objective is to ensure that patients are treated with safe and effective medical devices,’ said Hansson, adding that, in general, the MDR retains all the requirements of the old directives, while adding new measures. ‘The regulations will not completely reshape the medical device regulatory landscape, but will ensure that devices manufac- tured and used in the EU will fulfil the highest standard.’ Continuous process While all new medical devices cer- tificates will have to be delivered according to the new regulation from May 26, there is a transition- al provision under certain condi- tions for devices covered by the previous Medical Device Directive. Additionally, new regulations on in vitro diagnostic medical devices will become applicable. ‘Despite the challenges related to the implementation of the new requirements, in particular, during the Covid-19 pandemic, important progress has been achieved and the new legislation is now ready to be applied in practice. However, the work will not stop here because the development of guidance docu- ments is a continuous process that will last for many years to come,’ Hansson concluded. Erik Hansson is Deputy Head of the Unit for Medical Devices and Health Technology Assessment of the European Commission Directorate General for Health and Food Safety (SANTE), which is responsible for the legislation on medical devices. New responsibilities for the European Medicines Agency The MDR is introducing new or revised responsibilities for the EMA (European Medicines Agency). These affect: • medicines with an integral device, such as pre-filled syringes and pens, and pre-filled inhalers; • medical devices containing an ancillary medicinal substance to support the proper functioning of the device. Examples: drug- eluting stents, bone cement con- taining an antibiotic, catheters coated with heparin or an anti- biotic agent and condoms coated with spermicides; • medical devices made from substances that are absorbed by the human body to achieve their intended purpose; • borderline products for which there is uncertainty over which framework applies. Common borderlines are between medicinal products, medical devices, cosmetics, bio- cidal products, herbal medicines and food supplements. regulatory www.healthcare-in-europe.com CONTENTS 2-3 GENDER PARITY MANAGEMENT & 4-7 RESEARCH 8-11 LABORATORY AI & MAMMOGRAPHY 12-13 INTERVENTIONAL RADIOLOGY RADIOLOGY 14-15 16