notified bodies

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...