Bringing notified body auditing and testing together
As the regulatory requirements of the global medical device market are complex and vary between regions, manufacturers are faced with increased product development costs and time to market challenges. Richard Poate of TÜV SÜD explains.
In order to evaluate the compliance of their device against the Essential Requirements of the current Medical Device Directive (MDD); the Active Implantable Medical Device Directive (AIMDD); or General Safety Performance Requirements of the impending Medical Device Regulation (MDR), a manufacturer’s product and quality management system must undergo a conformity assessment process. They must also write technical documentation, as well as establish a quality management system which meets the relevant and applicable requirements.
In most cases, this process must also involve a Notified Body. A Notified Body is an organisation that has been designated by an EU member state and notified by the EU Commission to assess whether manufacturers and their medical devices meet the requirements set out in legislation. Manufacturers can apply to any EU Notified Body and, following an appropriate assessment, the Notified Body will issue relevant certification decision. This allows manufacturers to add the CE marking onto their products so that they can be placed on the EU market.
Typical activities that can be undertaken by a Notified Body include:
- Full quality assurance – the Notified Body will carry out an assessment of the manufacturer’s quality system, including design. They will also sample across the range of products and processes to ensure that the requirements are being met.
- Examination of the design – to ensure that products meet requirements, the Notified Body will assess the full technical documentation.
- Type examination – the Notified Body will assess the full technical information relating to each type of product and carry out appropriate testing of a representative production sample, to ensure that it meets the requirements.
- Verification – before the manufacturer can place products on the market, the Notified Body will either test every unit or every batch of product to ensure that they meet requirements.
- Production and product quality assurance – the Notified Body will carry out an assessment of either the manufacturer’s quality system, covering production and inspection (production quality assurance), or final inspection (product quality assurance). The Notified Body will also sample across the range of products to ensure that relevant technical files are available, as well as ensuring that the relevant processes being undertaken meet the requirements
- Conduct unannounced audits of manufacturers – it is now mandatory for Notified Bodies to conduct unannounced audits.
Notified Body involvement is not required for Class I devices which are not sterile, do not include a measurement function and are not reusable surgical instruments. However, Class Is, Im, Ir, IIa, IIb and III devices require the involvement of a Notified Body. This means that it is vital that manufacturers plan ahead from the start of the product development process, as any delays in the certification process could extend time to market.
Class IIa devices are generally low to medium risk. Class IIb devices are slightly more complex and are generally considered medium to high risk. Class III medical devices are usually those that sustain or support life, are implanted, or present potential unreasonable risk of illness or injury, for example implantable pacemakers and breast implants.
A joined-up approach
While medical device manufacturers must meet certification and testing requirements to legally place products on a global market which is governed by a broad range of national and international regulations and standards, they may not realise that they have an opportunity to streamline this process. There is often a presumption that because product testing and Notified Body auditing are discreet activities, that they must be undertaken by two separate entities. Testing is done first in the laboratory and a Notified Body audit is then bolted on top of that at the final stage of product development to gain certification.
To streamline the time to market process as much as possible, manufacturers can take a step back and a more pragmatic, joined-up approach. From the start of the process, a device manufacturer can establish what the regulatory expectations will be for both the final product and the test process that goes alongside it.
If you understand this from the start and engage with a Notified Body at this point, you can ensure that you increase your chances of meeting the legal and regulatory requirements of the set EC/EU legislation (directives, regulations) and international standards at the final certification stage. Also, a device manufacturer’s regulatory affairs team, which deal with certifications/audits and the CE Marking process, and R&D engineers are often very separate teams. So, they need to work more closely to expedite the process.
Also, think about your target markets from the start and how you can streamline the entire process, so that it is geared towards your end goal – to expedite selling a medical device to particular and multiple markets.