MDR

Policymakers spent years on agreeing on one of the most modern medtech rules in the world – this should not be undermined by revisions to horizontal legislation. As Brussels powers down for a short summer lull, I find myself in a reflective mode. The pandemic has transformed our lives – suffice to say that we have all worked through our share of challenges. Our industry has worked hard to implement major new legislation while coping with other pressures. The Medical Devices Regulation (MDR) entered into full legal application in May, and we continue to work tirelessly to prepare for the application deadline of the In Vitro Diagnostic Medical Devices Regulation (IVDR) in May 2022. Those of us who lived through the drafting and redrafting of those heavyweight legal texts can attest to the complexity of the process. The regulations will support a level playing field amongst approval bodies and the scope has been tightened up and includes more product groups. There will also be more oversight from authorities, and transparency on products will increase significantly. All of that will hopefully significantly strengthen the trust in the CE marking system, medical technologies and the new legislative framework alike. Nevertheless, there are already signs that the increased complexity for getting to the market – including new post-market responsibilities – may be turning some off investing in innovation or launching new technologies on the European market. Policymakers, industry and other stakeholders have made considerable efforts to ensure ex ante that the MDR and IVDR protect patients and promote access to innovative products and solutions. Medtech innovation, it should be said, is in the interest of patients and consumers. The philosophy embedded in the MDR and IVDR reflects this need. Today, I must confess to a sense of unease when I hear talk of...
On 26 th of May 2021 the EU Medical Device Regulation (MDR) became fully applicable. It is a modern piece of legislation that strives to ’ establish a robust, transparent, predictable and sustainable regulatory framework for medical devices which ensures a high level of safety and health whilst supporting innovation’ . It further aims ’to ensure the smooth functioning of the internal market as regards medical devices, taking as a base a high level of protection of health for patients and users, and taking into account the small- and medium-sized enterprises that are active in this sector’. ’ Both objectives are being pursued simultaneously and are inseparably linked whilst one not being secondary to the other ’, it states . I could not agree more with these phrases. There are two main objectives that are inextricably linked and need to be balanced: safety and innovation are mutually dependent. Fortunately, there are thousands of innovative ideas designed to improve people’s lives. The European Patent Office (EPO) [1] data for 2020 shows that the medical technology sector made the highest numbers of applications – 14,295 to be precise – putting it ahead of digital communication, electrical machinery, energy, transport, pharmaceuticals, and others. But the medtech industry is telling me a different story about the future! Many innovation projects in times of implementation of the MDR are being abandoned while improvements to existing products are no longer being made. Where manufacturers are seeking regulatory approval of medtech innovations, geographies beyond Europe with faster and more predictable pathways (e.g., in the US and others) tend to be preferred, at least for now. We are facing an imbalance between the above-mentioned goals of the MDR. More and more often I hear that products that are certified under the provisions of the old directives pose a...
After 4 years of transition period followed by a pandemic year, we reached the date of application of the medical device regulation 2017/745 on May 26, 2021. A lot of uncertainty is still associated with this date and key stakeholders are still questioning the readiness of the system. Twenty notified bodies out of fifty applicants were already designated for this legislation, more than sixty guidance documents clarifying the wording of the regulation were published and partial implementation of EUDAMED was achieved, but is it enough to ensure smooth transition from the old directives to the new legislative framework? It is positive to see twenty designated notified bodies for this legislation that are committed to support its implementation by continuously hiring and training new resources ensuring sufficient capacity for the various scopes necessary. Nevertheless, we should not forget that more than 80 notified bodies were available in 2012 and the system was not able to deliver predictable assessment and certification decisions. With the requirement for initial certification of all devices regardless of their market history, the prerequisites written in Article 120 and especially the expectation on notified bodies to apply appropriate surveillance ensuring continuous compliance of directives´ certificates during the grace period of the regulation from May 2021 till May 2024 it remains questionable if the current capacity will be sufficient. Therefore, it is key to start applying practical and reasonable interpretation avoiding additional burden on the notified bodies who are struggling to keep on track with the continuous changes and implement the requirements in a timely manner. Also positive is the publication of the huge number of guidance documents supporting notified bodies and manufacturers implementing the requirements. Nevertheless, we still miss key guidance documents and common specifications which are essential for the implementation of the regulation (e.g. appropriate surveillance, article...
In 2017 the European Commission changed and updated the legal framework regarding the medical devices, superseding the existing directives, with two new regulations which added new responsibilities for European Medicines Agency and national regulatory authorities. The two new regulations, the MDR 2017/745 on medical devices and IVDR 2017/746 on in vitro diagnostic devices are scheduled to be fully implemented (after a transition period) from may 26-th 2020 (MDR) and may 26-th 2022 (IVDR), respectively. During this transition period the existing EU directives (93/42/EEC, 98/79/EC and 90/385/EEC) will apply to any medical device tested to be put on the market but the manufacturers can opt to follow the new regulations under the condition of full compliance with them. The new directives demand a mandatory conformity assessment for all devices manufactured in the EU, to prove that they conform to the legal requirements, perform as claimed and are safe to use. Only after passing a conformity assessment the manufacturers can put a CE mark (Conformité Européenne) on their medical device. These conformity assessments will be conducted by accredited bodies, designated by EU member states. The procedure for obtaining the CE mark requires an audit of the manufacturer's technological workflow and an evaluation of the technical and scientific documentation supporting the performance and safety claims of the device. In the new legislation, the Clinical Research Organizations (CRO) are assigned a more important role in providing the scientific evidence and regulatory assistance during the whole process of placing a medical device on the market. The new MDR and IVDR directives emphasize a more robust clinical evaluation process to collect and analyze data pertaining to a medical device. They also require clinical evaluations to assess whether there are sufficient data to prove the compliance of the device with the requirements for safety and performance, when...
New Medical Device Regulation – an obstacle to progress
On May 25 th , 2017, a new era began. The date marks the beginning of the Medical Device Regulation, the MDR in short. It provides a new framework for the certification of medical devices in Europe and is supposed to increase the transparency of the approval and application of medical devices, as well as to improve patient safety. New guidelines are challenging for all parties involved Patient safety is always of utmost priority; everybody agrees on this goal. However, with the new EU legal framework, we, in the medical technology industry, are faced with existential challenges: New clinical requirements as well as comprehensive documentation and reporting obligations will result in an increased bureaucracy. This also threatens to overstrain the notified bodies, which will be intensified through the decline in the total number of bodies and also through the loss of the British notified bodies in the course of Brexit. A lack of implementation regulations due to delayed detail regulations of the MDR significantly reduce the three-year transitional period for companies’ implementation. In my opinion, this represents a very critical situation for the medium-sized MedTech sector. But it is not just the medical technology companies that are affected by the current developments: Patients’ immediate access to modern procedures, devices, and examination methods will be made more difficult, and innovation will be delayed. Pragmatic solutions for a stronger culture of progress A development that I see as very critical, considering that our goal is to bring medical progress to patients more quickly. Meaning there is a stronger culture of progress in patient care through new technical solutions, a positive atmosphere for medical and technical progress, and a quicker transfer of research findings. To expedite this development and to protect and improve the health of people all around the world, we need...