Number of Notified Bodies Pursuing MDR and IVDR Certification Continues to Dwindle

• Oriel STAT A MATRIX
• 0
• on Mar 03, 2018

It is commonly said that a rising tide lifts all boats. However, when the tide recedes it leaves many boats stranded, and this is exactly how some medical device and IVD companies will feel over the next several years.

Just a few years ago, Notified Bodies (NBs) were bountiful, accommodating, and hungry, but times have changed. Today, you are more likely to be the one doing the selling in the hope that your NB will continue to serve you in a timely manner, if at all.

Why EU NBs are becoming more scarce

The dramatic change in the marketplace has occurred for a few reasons. First, European Competent Authorities imposed new requirements on NBs to conduct random unannounced audits of their clients, an onerous stipulation imposed in the wake of the PIP breast implant scandal. Clinical data requirements have also become stricter under revised guidance document MEDDEV 2.7/1 rev 4, which increases scrutiny of clinical evaluations by NBs. Both of these factors, along with the 2017 passage of the European Medical Device Regulation (2017/745) and the In Vitro Device Regulation (2017/746), have also created a sizeable demand for qualified QA/RA professionals throughout the industry. These additional regulatory demands, combined with labor pressures, have in turn led to a burden that pushed some NBs over the edge. Many have decided that medical devices and IVDs are not an industry they want to serve any longer.

Big players will stay, but many smaller NBs are expected to exit the market

Today, there are 59 companies in the NANDO database currently accredited to audit medical device companies under MDD 93/42/EEC, and 22 accredited to audit IVDs under IVDD 98/79/EC. Those numbers are expected to shrink significantly as smaller NBs exit the market.

Recently, Team NB (the European association of medical device NBs) released a survey of their 24 members. These companies represent most of the familiar industry names and control the majority of the auditing and certification market. The good news is that 20 of their 24 have decided to submit an application for designation against the MDR. So, it would seem that nearly all Team NB members will seek accreditation. Beyond Team NB, there are an additional 15 NBs who will likely be designated to MDR, making for a potential total of 35 NBs. Likewise, of the 22 companies that are designated to audit against the current IVDD 98/79/EC, half are Team NB members. It would seem (according to the Team NB survey) that most or all of these 11 members have applied for designation under the IVDR.

What remains to be seen is the dropout rate among the smaller NBs, a percentage that is expected to be quite high.

Companies that will be affected the most:

Smaller European device companies

Companies located outside Europe are prone to working with one of the larger NBs, such as the 24 Team NB members. Many of the larger NBs have sales offices in the US and Asia, and thus have a more diverse international client base. Smaller NBs -which have perhaps 20% of the market  do not. They are much more likely to be serving local medical device companies, building their client list based on the benefits of proximity and commonality of language. As such, the (heavily) European-based clients served by these smaller NBs could well be scrambling to find a new NB as those smaller players withdraw and leave their clients high and dry.

Companies with tricky products working with smaller NBs

The decline in the number of smaller NBs that will seek accreditation under the MDR is not the only issue. Many smaller NBs may narrow the scope of products they cover. Even if you have confirmed that your NB is planning (or has) applied for recertification under the MDR and/or IVDR, you will want to get written confirmation that they still plan to include your device/IVD categories within the scope of their auditing capabilities. Newer companies producing complex technology need to be especially cognizant of this issue.

The good news is that half of the Team NB members applying for designation against the MDR and/or IVDR have indicated that they will be expanding the scope of their designation, and the other half indicated they would retain the same scope. If you are currently working with a Team NB member, you are probably safe. However, don’t assume – you should ask to be sure.

IVD manufacturers

The new IVDR does not go into effect until 2022, and that seems like plenty of time to prepare. The problem is that the IVDR will require most (around 80%) IVD companies to have their quality management system and technical documentation reviewed by an NB. While IVDs are a far smaller segment than devices, this will create a huge crush of demand on the draining pool of NBs that will be accredited under the IVDR. What makes this particularly alarming is that many smaller NBs are expected to forgo accreditation under the IVDR, leaving fewer companies to handle the surging demand. Thus, IVD companies that are currently under the scope of the IVDD 98/79/EC should be reaching out to an NB now to ensure their spot in line for auditing. IVD companies working with smaller NBs should ask their NB if they plan to pursue accreditation under the IVDR.

What’s next

On the positive side, it is encouraging to see that most of the larger players will continue to serve the medical device and IVD markets, with many expanding their scope. This will no doubt help (somewhat) absorb the loss of smaller NBs who call it quits. Still, the departure of smaller players – in combination with the tsunami of work yet to come – will magnify the burden placed on larger players already swamped with work. Without a doubt, this will lead to longer waits for audit scheduling, technical documentation review, and certification issuance, and thus ultimately higher prices.

What you should be doing now

Over the next few years it will be vital for medical device and IVD companies with existing NB relationships to keep in constant contact with their NB.

• Nail down audit dates earlier than you might otherwise have done in the past.
• Allow more time in your schedule for technical file reviews.
• If you are an IVD or medical device company that will now be subject to QMS implementation, get started right away.
• If you are a startup company in search of an NB, get on it right now regardless of your timeframe to market.

If you are in the unfortunate predicament of having to switch NBs, start early, be persistent, hope for a little bit of luck, and get everything in writing. Oriel STAT A MATRIX works with a wide variety of medical device and IVD companies on QMS and regulatory compliance, and our team maintains relationships many top NBs. If you need help in this regard, please let us know.