Background and overview of MDR amendments

Published in 2017, the MDR first became effective in 2021. Its introduction created a number of challenges for the industry, not least the accreditation of Notified Bodies to handle the influx of required product reviews. 

Companies with existing products on the market needed an update to their certification and a review by a Notified Body. The volume of products requiring recertification, coupled with new products coming on to the EU market, created a substantial backlog for Notified Bodies to clear. 

For these reasons, the major amendments relate to the timescales for compliance:

1. An extension to the certification deadline to give Notified Bodies more time to review critical products.
2. The requirement for companies with existing medical device products to have applied for a conformity assessment from a Notified Body before September 2024.
3. Entry into the vigilance database – EUDAMED – which will provide a ‘living picture’ of all medical devices on the EU market, and their product lifecycles.

Understanding EUDAMED 

Published in July 2024, the obligation for companies and their products to be listed on the EUDAMED comes into effect from January 2025. 

The European Database on Medical Devices – EUDAMED – increases visibility over medical devices and manufacturers. It collates information from different systems to provide the public and medical professionals with easier access to data. The system unites data from different EU Member States.

What medical device companies need to know is that there’s a phased approach to compliance, with each of the six modules becoming obligatory over time. The obligation to complete the first three modules is already in effect:  

• the Actors module;
• the UDI/Devices module;
• Notified bodies/Certificates modules. 

The next three modules relate to clinical investigations and performance studies, vigilance reporting, and market surveillance. These are stringent, ongoing, obligations which might take place multiple times per year.  

Changes to product discontinuation

There has also been a change to the requirement for medical device manufacturers to notify competent authorities and a Notified Body when a product is to be pulled from the market, under Article 10a. 

In the interest of patient safety, manufacturers will have a duty to investigate the market to assess the impact of product withdrawals. This is to avoid a scenario where there’s a known gap in the market – typically for highly-specialized medical devices.  

The changes will see a 6-month notification period coming into effect before a product can be discontinued, which should allow the authorities enough time to ensure a suitable alternative is available. 

The impact on products and QMS

The changes described above create an additional administrative burden on companies. Primarily, there’s the need to have a robust system in place for the voluntary withdrawal of a product. This is a new requirement that was not previously regulated. 

It has two major impacts: required updates to your in-house Quality Management System (QMS), and changes to the information shared publicly via EUDAMED. This was something that was previously required for any product safety concerns. Now, more detailed product information must be shared at a much earlier stage. 

The changes represent a notable shift, which manufacturers should not underestimate, in the detail required for initial registration. As obligations to conform with the EUDAMED modules come into effect, the level of detail needed for compliance will also increase to ensure availability and database input is completed in a timely manner.

The impact will be most keenly felt by companies with legacy devices, which face tougher requirements to keep their products on the market (and withdraw them). Ultimately, the changes are intended to reduce risk in the market, which is partly to do with cost.

Balancing the cost of compliance with patient safety

It’s not cheap to get a medical device product correctly certified for the EU market. There are legitimate concerns that the cost of compliance could drive products and manufacturers away from the EU market. At the same time, it’s mission-critical to ensure that the market is safe for patients and medical professionals. 

For example, imagine your company provides specialist equipment for treating rare diseases. The market for that product is much smaller than products destined for general use within a hospital, such as a heart monitor. Not only is there less product demand, there’s also the hurdle of collecting enough data from clinical trials to prove product safety. 

Companies with products transitioning from the previous regulation will be acutely aware of the increased clinical evidence burden. At the same time, profit margins will be squeezed by the regulatory burden – in some cases, the cost of product compliance reviews have increased three-fold. The review takes longer, and Notified Bodies increase their fees accordingly.  

One approach to cutting costs is to restrict the intended use of a medical product, which in turn reduces the amount of data collection needed. Sometimes, there are scenarios where discontinuing a product is the only viable option. Looking ahead, regulations might need to become more streamlined for certain product types to be viable to produce, and remain on the EU market.  

Future amendments to the MDR

The effectiveness of the MDR in the market is being constantly monitored. Right now, experts in Germany are exploring whether certain lower-risk devices could potentially be made exempt from recertification (currently every 5 years) as long as vigilance reporting, and the ‘state of the art’ are appropriately maintained. 

The MDR is already much more stringent than its predecessor – the MDD. Under the MDR, there is a requirement for post-market surveillance, not only responding passively to complaints or issues, but proactively monitoring and assessing ongoing risks related to correct product use – and misuse – by surveying users, and practicing physicians. At the same time, any significant changes to products have to be documented and approved for certification to remain valid. 

Clearly there’s already a requirement to manage and control the complete product lifecycle. Removing or extending the recertification time period – which involves an extensive auditing of the technical dossier – would allow safety standards to be maintained, whilst easing the administrative burden on companies, and free-up capacity at Notified Bodies. 

What’s certain is that future changes to the MDR are on the horizon. What’s uncertain is how your medical device company can best navigate them. That’s where the regulatory experience and expertise of Peercode’s Regulatory Consultancy comes in.

Challenged by changes to the MDR? It’s time to reach out to a regulatory specialist. Speak to one of our experts today. Contact us