Before a medical device can be marketed in the European Union (EU), it must undergo CE Marking certification and the manufacturer must affix a CE Mark on the device. In some cases, achieving certification will require the use of an EU Notified Body (NB), a third-party entity authorized by the European Commission (executive body of the EU) to perform audits and review technical documentation to determine compliance with applicable EU medical device regulations.
Manufacturers are required to contract with an EU NB if they intend to market the following medical devices:1
- MDD Class I sterile or measuring devices,
- MDD Class IIa and IIb devices (on a representative basis),
- MDD Class III devices,
- IVDD Annex II devices and self-testing devices, or
- AIMD active implantable medical devices.
Manufacturers may choose any NB listed in the New Approach Notified and Designated Organisations (NANDO) Information System.2 These are the only recognized third parties that can carry out audits in accordance with current medical device directives, including:
- Medical Devices Directive 93/42/EEC (MDD),3
- In Vitro Diagnostic Medical Devices Directive 98/79/EC (IVDD),4 and
- Active Implantable Medical Devices Directive 90/385/EEC (AIMD).5
Choosing the right NB is critical since switching between them can be time-consuming, logistically challenging, and expensive. NBs are authorized by the government of the relevant member state and the European Commission to perform assessments for one or more medical device directives (MDD, IVDD, or AIMD) and may be restricted to specific types of assessment methods for specific types of products. NBs also vary in their office locations and English fluency.
The changing regulatory environment in the EU contributes additional challenges to the selection process. Potential de-notification of some NBs, risks of NB shortages, as well as the future designation of Special NBs to work with high-risk medical devices, create a sense of urgency in some companies.
Notified Body Identification and Selection Process (Figure 1)
The first step in the process is to determine which individuals will be responsible for selecting the NB. This team should include representatives from the regulatory and quality departments. It may be helpful to include the manufacturing, purchasing, clinical, and engineering departments, as well as senior management. In addition, a third-party consultant with global regulatory expertise such as NAMSA can make a significant difference in how smoothly the NB selection and eventual certification processes go.
When preparing for the selection process, a summary of your company and products will help you identify what characteristics are needed from the NB, how long the audit will take, and what the fees may be for the auditing process. This summary should include a company description, the number of employees, relevant manufacturing processes, whether contract manufacturers are used, descriptions of each device with EU classifications, the Conformity Assessment method chosen (if applicable), and desired timelines. Following this, a list of characteristics needed from an NB can be prepared, including which directives and assessment methods they are authorized for, office locations, English fluency, and experience in desired therapeutic areas.
Figure 1. Notified Body Selection Process
A complete list of NBs can be found on the NANDO website.1 The list can be filtered by country, directive, and NB name, or can be searched using keywords. It can be used to determine which NBs fit the desired criteria. The NANDO website also provides links to NB websites that may be useful.Once a list of about 3-5 possible NBs has been compiled, each can be contacted to set up initial phone or face-to-face meetings. A well-structured information-gathering process should be used. Be sure to address topics such as whether they are authorized to perform the tasks you need, expertise of the NB and the potential company contacts, timelines, office locations, and costs. Some items to ask for during the interview are a detailed quote for all fees and services, a list of references, audit checklists they use, an informational package (data on the certification process and company background information), and an application package (with forms to be filled out and supplied to the NB). Keep in mind that some of this information may not be made available to prospective clients. If you plan to work with combination products, be prepared to explore the expertise of the national competent authorities—as some may be more experienced than others—and you may want to ask about what relations the candidate NBs have established with a particular competent authority.After acquiring all of the necessary information, the selection team can make the final decision. If the list can be narrowed down to two strong candidates, it may help to organize a final meeting with the specific individuals who will be managing the project and performing the audits.
A regulatory consultant such as NAMSA can facilitate with the selection process. NAMSA can assist by:
- Identifying appropriate NBs
- Performing pre-assessment audits
- Organizing meetings with NBs
- Conducting preclinical and clinical studies to support marketing applications
- Preparing Clinical Evidence Reports, Technical Files, and Dossiers
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- Contact Jean Pierre Boutrand for further information regarding this topic
- Visit our Regulatory page to read more about the different types of regulatory services NAMSA can offer you
- European Commission. Need for Notified Body? [updated 2014 Jun 3; cited 2014 Jun 16]. Available from: http://ec.europa.eu/enterprise/policies/single-market-goods/cemarking/professionals/manufacturers/notified-body/index_en.htm.
- European Commission. New Approach Notified and Designated Organisations (NANDO) Information System. [updated 2014 Jun 16; cited 2014 Jun 16]. Available from: http://ec.europa.eu/enterprise/newapproach/nando/.
- Council of the European Communities/European Economic Community. Council Directive 93/42/EEC on Medical Devices. 14 June 1993. Available at: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:1993:169:0001:0043:EN:PDF.
- Council of the European Communities/European Economic Community. Council Directive 98/79/EC on In Vitro Diagnostic Medical Devices. 27 October 1998. Available at: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:1998:331:0001:0037:EN:PDF.
- Council of the European Communities/European Economic Community. Council Directive 90/385/EEC on Active Implantable Medical Devices. 20 June 1990. Available at: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CONSLEG:1990L0385:20071011:en:PDF.