Despite the looming Brexit shadow hanging over all of us, smart organisations cannot help but attempt to navigate the stormy political seas in which they find themselves and continue to plan for the future as best they can. In the pharmaceutical industry, this is even more difficult due to the layers of legal and regulatory change and complexity in which the sector is immersed. One such change which sits on the horizon for operators across the supply chain is the implementation of the Medical Device Regulation ((EU) 2017/745) (the 'Regulation') in May 2020.
Key Changes
The Regulation came into force in May 2017 and replaces the Medical Devices Directive (93/42/EEC) (the 'Directive'). The upcoming implementation of the Regulation has rightly caused some concern in the sector, but what is the reality of how the Regulation differs from the Directive? We have set out below what we consider to be some of the key changes ahead:
- What is a medical device? The definition of a "medical device" has been significantly expanded and now includes software, as well as a change to "medical purposes" to include prediction. This means that devices/products which were not previously covered by the Directive could now fall under the Regulation.
- CE Marking and Conformity Assessment - The Regulation requires that all medical devices on the market in the EU hold a CE mark. This will mean that all devices will need to comply with the applicable conformity assessment requirements of the Regulation. However, because the Regulation imposes more stringent measures, this could mean legacy products may be reclassified as higher risk devices and result in additional obligations/regulatory red tape for the manufacturer.
- Unique Device Identification (UDI) - The idea behind the introduction of UDIs is to provide traceability of all medical devices; for example, the UDI will link the device to the UDI database which will include a range of information about the device and its manufacture.
- Heightened Safety Measures - The Regulations impose more stringent safety measures which will mean greater risk management for organisations; for example, more in-depth clinical data proving safety and performance claims, as well as tighter equivalency standards.
- EUDAMED Database - The Regulation establishes a centralised EU database for the storage of information on medical devices. This database will include information about each medical device from various economic operators, the Commission, member states and, in some cases, healthcare professionals and even the public.
- Economic Operators and 'Person responsible for regulatory compliance' - The Regulation impacts on all economic operators as it looks at the product lifecycle of the device, rather than the steps required to place the device onto the market (which was more the focus of the Directive). This means that organisations not previously caught by the Directive will have obligations under the Regulation, eg distributors. The introduction of new minimum criteria for a 'Person responsible for regulatory compliance will also need to be implemented.
- Notified Bodies - The Regulation requires that Notified Bodies apply for a new designation. It is expected that not all Notified Bodies will apply or be granted new designation successfully. This could mean moving Notified Bodies and increased waiting times for conformity assessments.
- Summary of Safety and Clinical Performance — For implantable devices and for Class III devices, manufacturers must create a summary of safety and clinical performance. The summary must be written in a way that is clear to the intended user, eg the patient, and once approved, will be available in the EUDAMED Database.
Top Tips
The key changes hint at a lot of work ahead; so what can your organisation do to weather this storm?
- Advice - Get advice on how the Regulation affects your business compared to the Directive. There is lots of free information from both the Commission and MHRA about the Regulation and its impact on organisations. If the budget allows, securing the advice of regulatory and legal specialists will save time when getting to the heart of what this means for your organisation as opposed to generic advice on sector impact.
- Assess - Once you have researched and have a good grasp of the Regulation, undertake a gap assessment of what gaps are created in your organisation by the changes from Directive to Regulation. What areas of your organisation need to change and what work is now needed? For example, does your organisation need to move to a new Notified Body?
- Transition Plan - Take the gap assessment and put in place a plan to plug those gaps. This plan should set out what needs to be done to help your organisation transition from operating under the Directive to operating under the Regulation, eg how to move to your new Notified Body and the steps required by the business.
- Implement - You know what is needed, you understand the gaps and you have a plan - so now you need to implement it. This can be done through the establishment of a working group or many working groups each with a specific task focus, eg recruitment of a 'person responsible for regulatory compliance' (general – training), safety and performance requirements, clinical evidence requirements, and postmarket surveillance requirements.
Conclusion
The face of medical device regulation may be changing, but you are not alone - use the guidance, take a practical approach (break it down and make it manageable) and have the conversations early to avoid the cost and pressure of last minute change.
If we can be of any assistance, or you wish to discuss the Medical Device Regulation further, please contact a member of our Pharmaceuticals and Life Sciences team on, or complete the form below.