Notified Body Fees And MDR Pricing For Medical Device Makers Explained
When you’re bringing a medical device to the EU market or any other country that’s adopted the EU’s Medical Device Regulation (MDR), there are two important things to factor into your compliance journey: time and cost. It can take months, or even years, to bring a medical device to market in the EU. And getting the correct certification isn’t cheap.
To get it there – and keep your product on the market – you need certification, and that requires a long-term relationship with an accredited Notified Body. As we uncover in this article, certification takes time and money, but there are actions you can take to speed up the process and keep a lid on the costs.
What’s the role of a Notified Body?
A Notified Body ensures that medical devices meet EU regulatory standards. It allows manufacturers to place products onto the European market that meet agreed standards in patient safety and device effectiveness.
Whether you’re new to the medical device market or are an experienced medical device manufacturer, it’s good to properly understand the role of the Notified Body. That’s because it’s not a one-time-only partnership – it’s for the long-term.
The role of a Notified Body is to ensure that medical devices meet the essential safety and performance requirements set out in EU regulations – specifically under the Medical Device Regulation (MDR) 2017/745 and In Vitro Diagnostic Regulation (IVDR) 2017/746.
Notified Bodies perform three main functions:
- Conformity Assessments to verify that your medical device complies with relevant regulatory standards. This process involves reviewing technical documentation, conducting audits, and possibly performing product testing.
- Certification is required for the device to be legally sold in the European Economic Area (EEA). After a successful conformity assessment, your Notified Body will issue you with a CE marking certificate.
- Post-market Surveillance is carried out by the Notified Body to ensure your ongoing compliance with regulations. This includes periodic audits of manufacturing facilities and reviewing any incidents or recalls related to the device.
These services are mandatory and come at a cost in terms of time and resources. The good news is that Notified Bodies are required under Article 50 to be transparent about their pricing.
Do Notified Bodies have standardized fees?
Yes, and no. Fees are standardized, in the sense that all clients pay the same fee for each of the services available from one particular Notified Body. But there’s no standardization across different Notified Bodies – each one sets its own rates. This is not strange as Notified Bodies are commercial parties.
As we’ve already mentioned, what is standardized – and mandatory – is that Notified Bodies must publish their fees so they’re open and accessible to the public. The challenge is that this publication can take many forms – from a lengthy downloadable PDF to a table of hourly rates. Some even provide rough estimations based on the types of dossiers submitted.
Needless to say, understanding and forecasting the fees of a Notified Body is something of a minefield. This makes it tricky to make an informed choice based on cost alone. To give you an idea of the approximate costs involved, here’s a table of fees from a selection of Notified Bodies in Europe:
Notified Body | Country | Audit Costs | TD Review Costs | Annual Fee |
DEKRA Certification B.V. CE 0344 |
Netherlands | €320 per hour €2,560 per day |
€450 per hour €3,600 per day |
€2,300 |
Kiwa Dare B.V. CE 1912 |
Netherlands | €300 per hour €2,400 per day |
€400 per hour €3,200 per day |
€2,750 |
TÜV SÜD CE 0123 |
Germany | €2,560 per day | €3,440 per day | €3,000 - €6,000 |
SGS Belgium NV CE 1639 |
Belgium | €3,000 per day | €3,700 per day | €6,000 |
TÜV Rheinland CE 0197 |
Germany | €2,320 per day | €3,120 per day | €1,000 plus license fees |
Scarlet NB B.V. CE 3022 |
Netherlands | €3,000 per day |
€3,000 – €4,100 per day |
Varies |
BSI Group CE 2797 |
Netherlands | €2,185 per day | €3,790 per day | €2,375 - €9,975 |
SIQ Ljubljana CE 1304 |
Slovenia | €190 per hour €1,520 per day | €1,920 per day | €1,500 |
Czech Metrology Institute CE 1383 |
Czech Republic | €1,400 per day | €1,920 per day |
€500 |
PLEASE NOTE: This is not a complete list nor a list of recommendations, also prices may change over time. Other Notified Bodies are available. Speak to an expert for advice on which one is right for you.
Actually, your choice of a Notified Body should be made on the basis of more than just cost. There are other factors to consider that could potentially save you time and money if you find a Notified Body that’s a good fit. These factors include:
- Their areas of medical device expertise;
- Geographic location;
- Language preferences (English or local language).
What you need and what it costs
There are two aspects to MDR certification for medical devices: process requirements and technical dossier requirements.
- Process requirements often involve ISO 13485 for your Quality Management System (QMS). QMS audits typically range from €250 to €350 per hour. A Stage 1 audit takes between 1–2 days to complete. Stage 2 can take between 2–30 days based on the size and complexity of your organization.
- Technical dossier requirements involve an in-depth review, which is determined by the risk class of the product. Lower risk devices (Class I) can take 2–6 days. Class IIa and IIb devices take between 6–8 days, and higher risk products – Class III – can take longer still, due to external expert reviewer time.
Additional costs
Some Notified Bodies offer a pre-application review to ensure both your QMS and medical device product are prepared for the certification process. This is where the Notified Body conducts an audit to help assess if you’re likely to meet the certification requirements or not. This is an additional cost to consider, especially when you did not involve an expert in your preparation.
During the certification process they’re allowed to perform two or three audit and/or review rounds. Beyond those, their involvement could become viewed as “advisory” and therefore no longer independent and impartial. A cost-limiting option here is to bring in regulatory consultants who have limitless availability and the right expertise to support and guide you through the process – minimizing the likelihood of a non-pass.
4 tips for managing the cost of certification
There are also a number of actions you can take to mitigate some of the costs involved with partnering with a Notified Body:
Tip 1: Certify a product family rather than a single product
It’s more cost-efficient to submit a file for a product family – rather than a single product. That’s because a Notified Body is allowed to perform product sampling on a product family – products with the same product code.
Tip 2: Work with a single Notified Body
If possible, aim to keep your products and your Quality System review with one Notified Body. This means you have less review overlap and only have to build one ongoing relationship, rather than working with different agencies and paying multiple invoices.
Tip 3: Ensure the right fit between you and a Notified Body
Make sure the Notified Body you choose is the best fit for your business and product. This is an expensive and long-term relationship – and it can pay dividends if you get it right. Get an accurate quote from each of the Notified Bodies, and make sure you have a good working relationship with your Product Manager or Case Manager. A strong working relationship, with clear agreed upon communication lines helps things run smoothly.
Tip 4: Check your Notified Body is future-proof
You can also cut future costs by selecting an accredited Notified Body that can handle your future product plans – such as developing a product in a higher risk class. If they’re not able to accommodate future changes, you may end up switching providers, which will cost you more.
Getting the best value from a Notified Body
It may be a mandatory partnership, but that doesn’t mean you can’t get decent value from your relationship with a Notified Body. Success comes from the alignment of two things: product and people.
It’s not easy to switch providers if there’s a problem, so choosing a Notified Body which has the right expertise for your product is crucial. At the same time, ensuring you have a good working relationship with your representative can have a huge impact.
Often, the biggest challenge is figuring out which Notified Body is right for you.
That’s where the experts at Peercode Regulatory Consultancy can help. Our focus is on the regulation, so we speak the same language as the Notified Bodies. We already have strong relationships with a wide range of Notified Bodies, so we can help connect you with the right people, as well as support you every step of the way on your compliance journey.
Bringing in our external experts is also a great way to get professional advice and an expert pair of eyes over your QMS and technical dossier before it’s submitted. This helps you avoid nonconformities and smooth the path to certification.
Discover how Peercode Regulatory Consultancy can help you achieve cost-efficient compliance with the MDR. Get in touch with us today. Speak to a specialist