Decoding The Medical Device Regulation For Manufacturers

Decoding The Medical Device Regulation For Manufacturers


For medical device manufacturers, getting started with the EU’s Medical Device Regulation (MDR) is a huge challenge. With over 120 articles, close to 20 annexes, and more than 200 pages – plus all the accompanying guidance documents – it’s an enormous regulation to decode. 

Not only is it vast, the MDR also continuously evolves alongside the state of the art, new standards, and related regulations (such as the AI Act). Even for experienced compliance professionals, it can be a challenge to correctly decipher the MDR. 

To help you get started, here’s our outline of the best starting point for medical device manufacturers to dive into the MDR.

Where to start with the MDR

Companies that manufacture medical devices for the EU market, must be fully-compliant with the entire regulation, where applicable.

MDR requirements touch every organization involved with medical devices, including manufacturers, importers, distributors, and Notified Bodies. There’s a lot of information to digest, and the key to understanding it is knowing where to start. For manufacturers, we recommend Article 10 and Article 5 – in that order.

Article 10 – General obligations of manufacturers

Manufacturers of medical devices are advised to start with Article 10 of the MDR because it sets out their general obligations. The article provides an overview and an indication of what’s needed for compliance. For that reason, it makes sense to view it as an initial checklist for getting started, which includes:

  • Quality Management Systems (QMS)
  • Regulatory strategy
  • General safety and performance requirements
  • Management team responsibilities
  • Risk management processes

Article 5 – Placing on the market and putting into service

Article 5 provides manufacturers with all the points they need to consider before putting a product on the market, and into service. Whilst we can highlight the most relevant aspects of the MDR for manufacturers, the salient point here is that a device can only be placed into service when it is fully compliant with the MDR.

There are a minority of exemptions for devices that do not need to be fully compliant with the MDR. For example, health institutions that have developed a device in-house, or modified an existing one. In these cases, a device must only comply with the QMS aspect of the MDR.   

Important MDR annexes 

These two articles – 5 and 10 – are a great starting point. But that still leaves more than 100 more for manufacturers to get their heads around. Most of the important details can be found in the MDR annexes, which provide a deep dive into what compliance actually entails. Here are the important annexes for getting started:

Annex I

Annex I provides a bulleted list of general safety and performance requirements, stating what the device must do in order to comply and how it should perform. Again, this acts as a checklist that’s one of the most important – if not the most important – in the MDR. 

If a statement on the list applies to the device in question, manufacturers must gather and document evidence that proves compliance. It’s verification and validation activities that enable manufacturers to prove compliance with the MDR criteria.     

Annex II 

Annex II acts as a checklist for the technical file, ultimately enabling manufacturers to identify which documentation is needed and know when it’s complete. If there’s a problem with a technical dossier submitted to a Notified Body, it’s often because an item on this checklist is missing. 

This annex helps manufacturers see what’s needed to market the product, things like the device description. It explains how to cover all the variants of a product, and why a Unique Device Identifier (UDI) is needed. 

Annex III

Annex III covers Post Market Surveillance (PMS). Whilst not necessarily top of mind in the initial stages, it nonetheless has to be decided upon early on in the process.

Annex VIII

Annex VIII defines different kinds of medical devices, helping manufacturers to correctly categorize their products. It also covers various rules around implementation. To help with this, manufacturers should access the substantial supporting guidance and examples from the Medical Device Coordination Group (MDCG). 

Moving from ‘what’ to ‘how’

Most of ‘what’ manufacturers need to know about compliance is common sense: a medical device needs to be safe; it needs to have a medical benefit; this benefit must be proven before the product goes to the market. But compliance with the MDR – the ‘how’ – isn’t straightforward. 

Knowing what needs to be done is one thing. Understanding how to go about it is another thing entirely. The reality is that a huge amount of research and knowledge is required, especially when defining how to devise a strategy to demonstrate a product’s clinical benefit. 

Proving the clinical benefit of a medical device is by far one of the biggest challenges facing manufacturers. It’s an undertaking comparable to proving a hypothesis in an academic paper. It’s also a hurdle so commonplace, that a standard for a clinical evaluation is currently in development.

Successful MDR certification requires clear definitions of what a device is, who it’s for, and what it will do. This is vital. Correctly defining these things helps ascertain its intended purpose. Sounds obvious, right? You’d be surprised how many manufacturers fall at this hurdle. 

Imagine that the intended purpose of a new medical device keeps changing. This has a huge impact on the timeline for certification. Or what if it turns out that the device does not actually have a medical purpose, and therefore does not fall under the MDR? We’ve seen many scenarios like these play out, and more importantly, helped manufacturers put things right. 

Getting it right first time 

It’s never too early to reach out for expert support with MDR certification. In fact, one of the keys to successful certification under the MDR is to bring in the right expertise at the right time. Our team of regulatory experts can support your MDR efforts with a range of services, including:

  • Classifying your medical device
  • Establishing the intended medical purpose
  • Coaching to upskill and empower your internal teams 
  • Streamlining your MDR processes with templates
  • Reviewing documents and guidance

Here at Peercode Regulatory Consultancy, we’re experts in every aspect of the MDR with the experience to back it up. We help manufacturers get it right at every step of the process, from defining a product’s intended medical purpose to planning what Post Market Surveillance will look like.

Speak to a specialist today