How MDR impacts your quality management system
Richard Poate, medical health services manager at global product testing and certification organisation TÜV SÜD writes about the effect of MDR.
The global medical device market is governed by a broad range of national and international regulations and standards, and medical device manufacturers must meet certification and testing requirements to legally place products on each market. As the regulatory requirements are complex and vary between regions, manufacturers are faced with increased product development costs and time to markets challenges.
There are further complications as medical device manufacturers will soon be confronted with major changes in the European Union’s decades-old regulatory framework which governs market access to the EU. The new Medical Device Regulation (MDR) replaces the EU’s current Medical Device Directive MDD (93/42/EEC), and the active implantable medical device directive AIMDD (90/385/EEC). This represents a major restructure to the medical device regulatory framework, with the MDR coming into force on 25 May 2017 and ending its transition period on 26 May 2020.
In order to evaluate the compliance of their device against the Essential Requirements of the MDD/AIMDD or General Safety Performance Requirements of the MDR, a manufacturer’s product and quality management system must undergo a conformity assessment process, with the involvement of a Notified Body in most of the cases. They must also write technical documentation, as well as establish a quality management system that meets the relevant and applicable requirements.
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 on to their products so that they can be sold anywhere in the EU market.
Role of the Notified Body
A Notified Body’s tasks will vary depending on the classification of the products concerned and the conformity assessment route a manufacturer has chosen. 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 onto 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 of manufacturers.
What products require a Notified Body?
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. This means that manufacturers can add the CE marking in the normal way and self-certify that their product meets the requirements.
Class Is, Im, Ir, IIa, IIb and III devices do need a Notified Body to be involved, so this means that it is important for manufacturers to plan ahead from the start of the product development process as any delays in the certification process could disrupt time to market.
Class IIa Devices are generally low to medium risk and are mainly devices installed within the body in the short term, for only between 60 minutes and 30 days. Class IIb Devices are slightly more complex and are generally considered medium to high risk, as these will often be installed within the body for periods of 30 days or longer. While they have an identical compliance route to Class IIa devices, there is the added requirement of a device type examination by a Notified Body. 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.
Streamlining the process
However, while medical device manufacturers are faced by such challenges, 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 i.e. a test lab and a Notified Body. Testing is done first, usually throughout the product development lifecycle – to verify that products meet legislative requirements. A Notified Body audit is then bolted on top of that at the final stage of product development – to gain certification, with both discreet activities done by two separate organisations.
To streamline the time to market process as much as possible, manufacturers should take a step back and a more pragmatic, joined-up approach. From the start of the process, a device manufacturer should 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 meet all of the Notified Body’s expectations and requirements at the final certification stage. Also, internally at a device manufacturer, the 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 this process, so that the entire process is geared towards your end goal – to sell a medical device to particular and multiple markets.