Playing by the rules: What you need to know about EU regulation
With many North American companies looking to do business in the European market, Phil Brown, ABHI director, technical and regulatory, outlines some of the regulatory considerations that need to be taken into account.
For a product to be placed on the European market, it must meet the requirements outlined in the relevant regulation and be affixed with a CE Mark. The current EU regulation for health technologies is undergoing change, with the existing Medical Device Directive (MDD) being replaced by the new Medical Device Regulation (MDR), first published in 2017.
The culmination of eight years’ work, the MDR will ensure that European regulation for devices is considered the ‘gold standard’ globally. For our industry, this new regulation modernises the original MDD rules, bringing together best practices from existing Commission guidance whilst covering newer technologies such as nano-materials and human tissue derivatives.
The updated requirements demand a more robust compliance with elements of quality management, risk management, distribution control, transparency, post-marketing surveillance and training. These elements are now ingrained within the business process, ensuring that CE Marking has a more holistic feel.
In conjunction with the transition timelines, there are several aspects that companies need to address to allow for the future CE Marking of their products. However, until May 2020, either the new MDR or the old MDD can be applied to medical devices being placed on the European market. Beyond May 2020, all new products must comply with the new MDR.
This all sounds reasonable and logical of course, but there are caveats and nuances that impact on these timeframes and that will influence company strategies surrounding their product portfolio. For example, a notified body that will certify ‘conformity assessment’ of a product or quality system, must apply to be accredited under the new scheme. Only accredited bodies can issue certificates against the new MDR. This application and accreditation period is underway, with the first notified body accreditation expected towards the beginning of 2019 at the earliest. This does not leave a great deal of time for companies to organise certification and CE Marking against the MDR and requires early dialogue with their notified body. This, before we consider the overall capacity of notified bodies.
One standard of the ‘new legislative framework’ is EN ISO 13485, which controls the quality management system of a manufacturer. Quality management considers all aspects of the manufacturers activities, from product conformity to management responsibilities and actions. Unlike the MDD, the new regulation includes aspects of quality management within its legal text. The regulation demands details of quality objectives, organisation of the business, design and development, as well as details on post-marketing plans and activities.
The ‘declaration of conformity’ therefore, which is the legal document stating that a given product is compliant with the regulation, demands that aspects of management review and business practice are carried out, and that these aspects are audited by the notified body. The signatory to the ‘declaration’ must be cognisant of such processes to be assured that compliance requirements are met.
The MDR also requires manufacturers to have greater control over the distribution of their products. All ‘economic operators’, which includes the manufacturer, authorised representative, warehouses, importers and distributors, have defined roles and responsibilities. Indeed, all have a responsibility for ensuring that only products that are MDR compliant are placed on the EU market.
Manufacturers must have complete transparency of their distribution network, including sub-distributors. In addition, the authorised representatives must have a ‘person responsible for regulatory compliance’, who effectively releases only conforming products onto the EU market.
Post marketing surveillance is considered as both reactive and pro-active, in that it covers vigilance and adverse effects, as well as continual monitoring of products in use. Both are critical to understanding how a product performs and how product ‘risk’ changes.
The MDR requires that these processes are audited by the notified body, as they form part of the legal text rather than part of European guidelines. A company must also have plans for conducting post-marketing clinical follow-ups either to verify or enhance product performance. These activities are then used to update risk management documentation, drive product development processes and determine lifecycle needs.
In addition, the MDR mandates the development of a database called EUDAMED, which when fully implemented will house data on vigilance, clinical performance, clinical investigations and product literature. Certain parts of this data will have to be made publicly available, which will certainly help to debunk the mystery of medical devices!