Medilink North of England News Autumn Winter 2018 Volume 2 - Page 5

MEDICAL DEVICES (MDR) AND IN VITRO DIAGNOSTIC MEDICAL DEVICES (IVDR) REGULATIONS REGULATIONS FOR MEDICAL DEVICES - KNOW YOUR MARKET WHAT YOU NEED TO KNOW AND WHY THAT MATTERS ADNAN ASHFAQ, DIRECTOR OF PHARMI MED LTD. In this feature we explore the perspectives of three organisations working at the coal face of regulatory reform and implementation THE IMPACT OF THE NEW EU DEVICE REGULATIONS ON THE MEDTECH SECTOR - JOHN WILKINSON, DIRECTOR OF MEDICAL DEVICES (MHRA) We live in an increasingly digital world where manufacturing methods are evolving and new, innovative technologies are improving the way we treat diseases and health conditions. However, EU regulators struggled to keep pace with the ever-changing environment. Twenty-fi ve years ago, when the Medical Devices Directive was published, legislators could never have predicted that manufacturers would be 3D-printing devices or manipulating human cells to incorporate within devices. The new EU Medical Devices (MDR) and in vitro Diagnostic Medical Devices (IVDR) Regulations, which entered into force on 25 May 2017, introduced this much needed update to accommodate this evolving landscape and create a more thorough and consistent framework for manufacturers, regulatory authorities, and other relevant actors to operate in. Key changes have been brought about with the MDR and IVDR across almost all areas. Updated defi nitions bring a number of new product groups into scope, where certain groups of products without an intended medical purpose will be regulated as medical devices for the fi rst time. As well as 8 introducing new risk classifi cation rules, increased requirements for clinical evidence mean that manufacturers will need to closely examine their portfolios for changes in requirements. In addition to more rigorous vigilance reporting requirements, manufacturers and authorised representatives will now be required to employ at least one person who will need to fulfi l a number of responsibilities to ensure regulatory compliance. Most signifi cantly, there will be a greater emphasis on traceability throughout the whole supply chain through the introduction of a unique device identifi cation (UDI) system, enabling greater control over safety alerts, potential recalls and surveillance tasks. There are a number of additional changes that the new Regulations introduce to those mentioned above, so we recommend that you familiarise yourselves with these and begin to implement a transition plan for meeting the new requirements. The MHRA’s guiding principle remains that we ensure patients are not disadvantaged; that the UK will continue to play a leading role promoting and ensuring public health; and that industry must be able to get their products into the UK and EU markets as quickly and simply as possible. The EU Medical Devices Regulation will be fully applied from May 2020, during the implementation period agreed with the EU. This would not automatically follow for the new EU Regulations for in vitro diagnostic (IVD) medical devices, which does not apply until May 2022. However, Lord O’Shaughnessy stated in September 2017 that elements of both new Regulations have been applied directly in UK law since May 2017, meaning that devices, including IVDs, can now be legally placed on the UK market if they are in conformity with the new Regulations, invoking all relevant requirements. We at the MHRA are dedicated to providing support and guidance to industry and will be continuing to upload helpful documents on the new Regulations on our webpage, so be sure to check these out. HOW READY ARE YOU FOR THE NEW MEDICAL DEVICE REGULATION? (BSI) The fi nal text of the new European Medical Devices Regulation (MDR) has been published in the Offi cial Journal of the European Union. The Regulation entered into force on May 25th 2017, marking the start of the transition period for manufacturers selling medical devices into Europe. Enter - 25th May 2017 and the much discussed new European regulations replace both the IVDD 98/79 EEC and the MDD 93/42 EEC with the IVDR -2017/746 and MDR – 2017/745 respectively. The focus on the new regulations has been increasing patient safety, lowering risk and putting more responsibility in the hands of the legal manufacturer and also the notifi ed bodies, making the launch to market more diffi cult, with further layers of due diligence. So for anyone launching a new Medical Device into Europe, here are a few things to think about – • Wider scope of regulated medical devices • More stringent Clinical Evidence and documentation is required (Medilink’s in-house team provide an extensive service in this area to industry, please contact connect@ medilink.co.uk for further info) • Increased focus on Identifi cation and Traceability including UDI (Unique Device Identifi cation) • Defi nition of Common Specifi cations • Unannounced factory audits The MDR, which replaces the Medical Devices Directive (93/42/EEC) and Active Implantable Medical Devices Directive (90/385/EEC), has a transition period of three years. Manufacturers have the duration of the transition period to update their technical documentation and processes to meet the new requirements. • Increased Notifi ed Body involvement This long awaited text brings with it more scrutiny of technical documentation; it addresses concerns over the assessment of product safety and performance by placing stricter requirements on clinical evaluation and post-market clinical follow- up, and requiring better traceability of devices through the supply chain. • Large changes to economic operators – suppliers etc. The start of this long process of change occurred on 26 September 2012, when the Eur opean Commission adopted a Proposal for a Regulation of the European Parliament and of the Council on medical devices and a Proposal for a Regulation of the European Parliament and of the Council on in vitro diagnostic medical devices, which replaces the existing three Medical Device Directives. The BSI Team is here to support you on your journey, so please talk to us about your plans early on in your preparation. Further information can be found BSI MDR revision page www.bsigroup.com/ MDRRevision. • More rigorous vigilance • More focus on novel technologies, combination, software etc. • Changes in Classifi cations some Class IIa is IIb, some Class IIb to Class III • PSUR • Implementing and delegating acts • Common specifi cations where no harmonised standards exist • Authorised Rep – increased responsibilities So which market – is EU right for you? The US market has a 45% global market share, worth over $180 billion, so bearing in mind the above challenges and the potential knock on effect on timelines to reach market due to the increased workload above, perhaps the US 510K route may be a more amenable market for your device? Submissions can take anything from one month to 30 months, depending on Classifi cation and device risk. According to Emergo, 142,000 devices have cleared FDA 510(k) approval and that’s only 35% of the entire volume of devices, with the remaining 65% of devices exempt from the 510 (k) process. So perhaps the US market is worth looking towards for your device as a lot of uncertainty currently looms over the EU market. The take home point is – know your market, develop a regulatory strategy, but above all do not take risks in your regulatory approach. 9