Selecting and Working With Your Notified Body for Entering European Market
Notified Bodies (NBs) in the EU
Selecting the right Notified Body (NB) can be challenging. Which NB is right for your organization and what has changed with the introduction of the new EU MDR? Many small to mid-sized medical device companies are attempting to address these questions as they develop their MDR compliance strategies. In this article we will outline some of the criteria to use when selecting a Notified Body and how best to work with them within the European market.
What Is A Notified Body?
An NB is a public or private organisation designated by a competent authority of a member state of the European Union to carry out specific conformity assessment tasks specified in the European regulations. Until now, NBs have assumed more of a consultative role to help manufacturers meet CE marking requirements. Now, under the new MDR and IVDR, these organizations will serve as enforcers of the new regulations evaluating all applicable medical devices.
Identification Criteria for Notified Bodies
A critical point to consider when identifying a potential NB is whether it has been designated for the services needed for your device portfolio. Not all NBs can certify compliance with all conformity assessment procedures, nor are all device types necessarily covered. The first place that you need to look before choosing a NB is the New Approach Notified and Designated Organisations (NANDO) website, which is published and maintained by the European Commission. This is an electronic register that allows users to search for information related to notified bodies, including their location, the regulations that they are designated to, and conditions they may operate under, as well as exclusions, if any.
Notified Bodies Designated by the EU MDR 2017/745
The table below lists the notified bodies designated by the EU MDR 2017/745, along with their scope. It is essential to check for exceptions to the designations/scope; some NBs have indicated that they have been selectively including or excluding scope codes.
At this point, it’s worth contacting and engaging in discussions with the respective NBs. Some are not taking on new clients and it may be useful to have this clarified at the outset. The next step is to arrange a face-to-face meeting, where you can ask all the questions that you may have. Manufacturers need to decide on the conformity assessment procedure they wish to follow to CE Mark their devices. Manufacturers should not wait until the last minute to select a notified body, as this process is quite lengthy.
Increased Demand on Notified Bodies With the Introduction of MDR
Article 120 of the EU MDR 2017/745 does allow CE certificates issued by NBs before the 26th May 2017 to remain valid until their expiry date or at the latest until May 26, 2022. However, CE Certificates issued after May 26, 2017 will remain valid until their expiry date or until 26th May 2024.
With the introduction of MDR, there is much heavier scrutiny from the competent authority. The regulation has many specific requirements, creating an increase in NB workloads and decrease in NB availability. Prior to the introduction of MDR, 55 NBs accredited to audit medical devices under MDD 93/42/EEC, and 22 certified to audit IVDs under IVDD 98/79/EC, were listed on the NANDO database. The list that intended to apply for designation under MDR has shrunk significantly.
A Scarcity of Notified Bodies
A significant number of NBs exited the market because of the scarcity of skilled evaluators, which has created a significant bottleneck. According to – “Notified Bodies Members’ Intention to Apply to be Designated against MDR and/or IVD”– a document published by Team NB – it is intended that 23 of the larger NBs would apply for MDR designation. It is anticipated that higher risk classes will encounter delays in product approvals and slower device entry-to-market. Additionally, with notified bodies now required to review more significant volumes of data, the timelines for approvals/rejections have lengthened, increasing overall costs. In fact, this may result in long delays before the review process can even commence.
Requirements for Subject Matter Experts (SMEs)
There are also stricter requirements on the expertise that the NBs must employ, ensuring that they have adequately trained Subject Matter Experts (SMEs). Furthermore, several devices have also been up classified and now require more assessment.
Impact of Brexit on Notified Bodies
Moreover, Brexit has led many manufacturers to take the decision of seeking a NB within the European Union and relocate the legal manufacturer to an EU country by registering with the Competent Authority, ensuring they have an EU Authorised Representative (AR). For more Brexit info, read our recent blog post on the impact of Brexit on the life sciences industry.
Average Certification Period
The average certification period is around 9 months to 1 year for lower classification of products, and longer for more complex products. Article 54 of the new regulation introduces a new “consultation procedure” for NBs, under which they must submit the Clinical Evaluations of specific high-risk devices to an expert panel for review. Similarly, Article 55 introduces a new “mechanism for scrutiny of conformity assessments” for specific high-risk devices. These new obligations on NBs are likely to impact the approval timeframes.
Getting the Most Out of Your Notified Body
So, what are notified bodies looking for? First and foremost, device manufacturers need to build trust with their NBs and invest in a long term, strategic relationship. Some NBs assign client managers as a single point of contact. It is in your benefit to establish communication with the NB as early as possible and obtain clarifications where needed. Secondly, to simplify their process and make it more efficient, ensure that all technical documentation meets the requirements. Documentation should be presented in an easy to navigate, straightforward manner, with clear and concise tables of contents, such that all necessary information is easy to access and does not require unreasonable lengths of time to obtain. Parts of the technical file should be split up and sent out to the relevant SMEs for their expert review. Previously under MDD, the file would be submitted to one reviewer who would typically look at the technical file in its entirety, unless that auditor was not covered for specific codes, like sterilisation. Under MDR, however, it should be structured to allow it to be segmented, with clear definitive sections, thus ensuring traceability throughout the dossier/file.
Notified Body Certificates
Annex XII MDR lists specific requirements relating to Certificates issued by a NB. Under MDD, not all notified bodies explicitly listed product codes on CE certificates (other than Class III certificates); they permitted freedom, by defining a technology. Other notified bodies allowed matrix certificates, which contained the critical product parameters. Consequently, new products that fell within the scope of a matrix certificate and had specifications that fell within specifically defined parameters were automatically covered by the same CE certificate. However, MDR Annex XII, chapter II, states that each Certificate should contain unambiguous identification of the device. Other minimum content of the certificates are specified. Understanding how the NB will address these requirements are essential areas to be discussed when you have the initial face-to-face meeting with your potential NB.
Importance of Choosing the Right Notified Body
Device manufacturers planning to market their products in the EU should carefully identify the capabilities of the notified bodies under consideration before entering into a contractual relationship with such an organisation. Your chosen notified body must assess your company’s current and planned designs, technical documentation, and quality management system. You should assess your requirements as a medical device manufacturer, and whether the expertise and experience that your chosen NB holds and are willing to share is right for you. It is also important that from the beginning you have clarity on and fully understand what they deem as ‘significant change’ and that they have clear policies on handling product changes. Carefully choosing the right NB can save you time and money and increase your chances for successful marketing.
Selecting, swapping, and engaging with your NB are critical aspects for your business. Engaging with the right partner that holds the relevant expertise and passion for driving innovation forward is imperative for business growth. The potential threat of the lack of NB availability and the resultant delays is the industry not being able to supply medical devices to the patient/user, and the danger of stifling innovation; a situation best avoided!
Helping You With Notified Bodies and Regulatory Challenges
Celegence has a wealth of knowledge to help you navigate through complex regulatory challenges, and we can assist you with the selection of new NB, support your audits, assist your team in authoring responses to the competent authority or NB, and subsequently expedite market access for your Medical Device.
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