notified bodies

With the updated in vitro diagnostic medical devices (IVD) classification moving at least 80% of IVDs under Notified Body scrutiny (compared to 20% previously!), most manufacturers should now be gearing up to shift from self-certification to notified body oversight as we enter into the third year of the In Vitro Diagnostic Regulation's transition period. A crucial issue manufacturers need to assess is whether they have the necessary clinical evidence to comply with the regulation. Due to a lack of previous experience with notified bodies, and a perception that there is still a lot of time before the transition period ends in 2022, some manufacturers are underestimating how much evidence is now required to support the safety and performance of their device(s). The new IVD classification system is based on defined risk-based categories, where 'A' is low risk and 'D' is high risk; higher risk entails greater requirements for clinical evidence as well as greater oversight from a notified body. The challenge for legacy products is that grandfathering is not an option, meaning that each device must be re-assessed according to the level of risk. According to the IVDR, clinical evidence must support the intended purpose of the device as stated by the manufacturer and be based on a continuous process of performance evaluation, following a performance evaluation plan. Performance evaluation reports should demonstrate the following elements: scientific validity; analytical performance; and clinical performance. Scientific validity: • How much research has been conducted in relation to the device and its intended purpose? • How robust are the results of proof of concept studies? • What technology is the device based on? Analytical Performance: • Which tests have been carried out? • Which standards were used for these tests? • Are these standards harmonized? • How much-recorded evidence exists? Clinical Performance: •...
The new EU regulations on medical devices and in vitro diagnostics (IVDs) share a laudable aim: They seek to modernise the regulatory framework and enhance transparency. The goal, shared by all stakeholders, is to enhance patient safety without harming innovations that improve patient outcomes. However, with these two regulations coming into force by May 2020 (for medical devices) and May 2022 (for IVDs), I sense a growing concern from manufacturers. The immediate worry is about keeping existing products on the market and there is growing unease about how to ensure new products reach patients efficiently. As you may know, medical technologies must carry a CE mark if they are to be marketed in Europe. This well-established and highly recognisable logo carries significant weight and is trusted by consumers. CE marks for medical devices and diagnostics are issued by Notified Bodies – a vital component in the regulatory machinery. The challenge facing medtech is that the new regulations introduce additional responsibilities for Notified Bodies, requiring them to do much more work than before. For example, under the current Directive, between 80% and 90% of IVDs do not need approval by Notified Bodies. Under the new rules, this will reverse: the majority of diagnostics manufacturers will need to engage with NBs. This will mean 35,000 IVDs will be covered by Notified Bodies for the first time. The problem I see with this is that Notified Bodies will, under the changed rules, be subject to increased oversight by Competent Authorities. In short, they need to meet more stringent requirements than in the past if they are to be recognised. Today, there is just one Notified Body designated under the Medical Devices Regulation – the BSI based in the UK – and just 36 others have submitted applications to the European Commission. Not all...
As I followed the 1,075 km cycling route starting at the Belgium coast and ending in Basel, Switzerland, along the Western Front line of the First World War, I began to consider the plight of soldiers and generals a century ago. For military leaders, it was impossible to have an overview of what was happening on the battlefields; those in the trenches could see no more than 200 metres in front of them, with limited visibility left and right. Nobody had a full understanding of what was going on at all levels simultaneously. There is a parallel to be drawn with the current turbulent times for medical devices in Europe. Keeping devices on the market currently appears to be an endless battle with deadlines. In 2013, the unannounced audit program was introduced, and implemented by Notified Bodies in 2015; in 2016, Revision 4 of the MEDDEV on Clinical Evaluation was launched; 2016 also saw the introduction of a new version of ISO 13485 on quality management systems for medical devices; and in 2017, the MDR and IVDR were introduced, with a 3 and 5-year transition period respectively. EU medical devices rules are not the only front. We've had the GDPR, new requirements for the Canadian and US markets, and there are indications that the updated version of ISO 14155 on clinical studies will be published soon. All these changes require additional work and most of them deeply impact CE-marking. Missing one of these deadlines can lead to a device no longer being able to be placed on the European market. This “perfect storm” may look like a local European problem, but manufacturers from all over the world depend on the CE-mark. In hospitals worldwide the loss of a single certificate may cause a cascade reaction of unavailability of products and...
W ith 45% of devices accessing the EU via UK NBs, what would be the impact of a so-called “hard Brexit?” The political landscape is far from clear. However, BSI would concur with the recent MHRA paper as we fully anticipate remaining part of the EU system for the long term. We also agree that nothing will change during the implementation period to 31 st December 2020. Netherlands – BSI Designation There is much discussion and we are very pleased to confirm BSI is almost complete in our MDD /AIMD application with a target date we are working towards agreed between BSI NL and IGJ of Q3 2018 for MDD/AIMD designation. With this in mind, if driven by a “non-negotiated” or “hard” Brexit outcome, there is a need to rapidly migrate CE certificates to the Netherlands. We have a relatively straightforward process (this does not require additional conformity assessment) agreed and the plan is resourced to deliver the change within the required timeframe. We have shared this information with our clients around the globe. If there is a non-negotiated Brexit outcome resulting in the need to migrate all certificates to the new NL NB, the advice we have received from IGJ (NL Healthcare Inspectorate), NL Ministry of Health and the EU Commission, is that a new NB number relating to our NL designation is required and it is not possible to retain our existing NB 0086 number. (BSI does however plan to retain the existing certificate number). Whilst this raises the spectrum of potentially requiring additional resources for relabelling, BSI can confirm that the relabelling requirements normally associated with transfer from other EU Notified Bodies can justifiably be prolonged (NBOG BPG 2006-01). This has been discussed with the Designating Authority in both our initial designation Joint Assessment and recent follow-up...
It is now circa ten months since any well-prepared Notified Bodies (NB) wishing to undertake conformity assessment under MDR (EU) 2017/745 and IVDR (EU) 2017/746 were able to submit formal applications. The date of application of the MDR and IVDR, 27 th May 2020, is currently 20 months away. I would like to publicly acknowledge the significant effort and singular focus of the Competent Authorities (CA) to progress applications and meet the forthcoming deadlines. Given the hiatus before any applications could be formally submitted in November 2017, even the earliest NBs are unlikely to be designated until 2019 – leaving just one year remaining of the original three-year transition period. For BSI, our contact is with our primary CAs the MHRA (UK) and IGJ (NL). Both have been extremely supportive. BSI submitted its applications on day one for both regulations in both jurisdictions. The response from the MHRA was equally rapid and we were fortunate to be the very first NB to undergo MDR JA in early April this year. The MDR/IVDR Commission & Competent Authority Joint Audit (JA) of NB is a crucial process. However, there is concern, regarding the availability of resources given the need to handle all applicant NBs in a timely manner. Recent data published by The European Association for Medical Devices of Notified Bodies (TEAM NB) in July 2018 suggest 11 JAs are currently in the diary (six completed, four scheduled and one with a date to be confirmed). A further five NBs expect to submit this year. So, what are the implications for market access and, more importantly, patient care? Here are what I see as the three primary issues: 1. Many NBs (circa 16) are not ready to apply in 2018. Recent data from the European Commission DG SANTE corroborates Team NBs data...