Double-Edged Sword
Consequences for Medical Devices in case of a no deal Brexit.
Over the Counter (OTC) remedies may not seem like an obvious destination for medical devices, but the self-care medical device market faces change and uncertainty impacting products sold in both the UK and Europe.
The rules governing medical devices are changing and with them the role and responsibility of Notified Bodies –often the first regulatory point of contact for device manufacturers. Layered on top of this is Brexit and a potential no deal scenario affecting the sale of CE marked devices for the UK and European markets.
The Medical Device Directive(MDD, 93/42/EEC) was implemented 14 June 1993. This guidance has been revised and replaced by the Medical Device Regulation(MDR, EU 2017/745) on 26 May 2017. Many of the amendments have been driven by safety and the need to protect the consumer. PIP silicone breast implants were a trigger that change was required. Today the rules are in transition, with the MDR fully enforced for new devices from 26 May 2020.
The change in rules may seem to many, to be far enough away not to cause concern today. The amendments have far reaching consequences meaning that future strategies should consider the impact now.
Changes to Medical Device Regulations
A significant change within the MDR is that all new and existing devices need full clinical evidence, potentially in vivo,as bibliographic data alone is no longer sufficient. For any company considering the purchase of a device opportunity must complete their due diligence carefully, in particular for the evidence that supports the claim on the product sold. No clinical data in the future will mean no label claim. For the self-care market this loss of claim is not sustainable. Companies need to consider how they will bridge the data gap for existing CE marked products. In addition, further consumer protection will be supported by medical device vigilance, with the EudamedDatabank effective from 26 May 2020.
A secondary impact of the MDR is the reduced capacity within the regulatory system to deal with an increased workload. In 2014, 85 Notified Bodies were in existence in Europe. By the introduction of the new MDR, the number of Notified Bodies, with the new designation, had dropped to 24. A notified bodyis an organisation designated by an EU country to assess the conformity of certain products before being placed on the market. No Notified Body –no conformity assessment –no CE marked medical devices. For some medical devices they will be need to be reclassified under the new rules iefrom Class I to Class IIa, requiring NB input. Fewer Notified Bodies with additional conformity assessments adds to the capacity constraints.
Affects of No Deal Brexit
If no deal Brexit is an outcome then medical devices with a UK CE mark cannot be released for sale in Europe, likewise EU CE marked products cannot be released for sale in the UK. The UK government has developed a contingency plan, the UKCA(UK Conformity Assessed) marking will be the new UK product marking for medical devices. There is some guidance to read to see if you will need to use theUKCAmarking. Guidance for UKCA marking.
The UK government says ‘The rules around using the newUKCAmarking will mirror those which currently apply for the application of theCEmarking. If your products require third party assessment of conformity, and if this has been carried out by a UK conformity assessment body, you will have to apply the newUKCAmarking if/when the UK leaves the European Union. This will not be the case if the certificate of conformity has been transferred to an EU-recognised body (in which case theCEmarking would apply). If you currently rely solely on a self-declaration of conformity for theCEmarking you will also be able to use theUKCAmarking based on self-declaration, for those products within scope of the marking. TheUKCAmarking will not be recognised on the EU market, and products currently requiring aCEmarking will continue to require aCEmarking for sale in the EU.’ Further uncertainty with the Brexit process, with new exit dates pencilled in as 12 April, 22 May add to unwelcome ambiguity for manufacturers.
This guidance was published 2 February 2019.
As the deadline draws nearer, so more guidance is issued. In March NHS England set out a Frequently Asked Questionsdocument about supply of ‘medicines’ in the event of a no deal Brexit. Medical devices do not require pharmacist intervention and so do not figure within the contingency planning and stock piling to support the self-care market.
Many questions, not all the answers are easy to see or predict. Interesting times ahead. In a period of change, strategic thinking is critical to maintain your current devices on the market. Likewise, there factors to consider if you are considering the acquisition of a new portfolio. Caveat emptor.
Medical devices with either UK or EU manufacturers (and with UK or EU Notified Bodies) in the mid to long term will find a way to be commercialised. Short term, consumers looking for solutions in the self-care market may find their options are reduced until the paperwork is resolved. If you have not taken the time to consider your medical device portfolio, sooner rather than later is the take home message.