Are you a quality manager for a small medical device start-up looking to expand into global markets? Or maybe you are a seasoned device manufacturer preparing to once again traverse quality regulations to deliver a new product to the European market?
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Factory
Factory working on medical mask production.
Whether this is your first foray or your hundredth, the changes in European Union (EU) and United Kingdom (U.K.) regulations in the last few years have likely left you a bit confused and potentially holding a laundry list of questions and concerns. You are not alone. There is still plenty of uncertainty regarding the U.K.'s regulatory bodies and requirements, their differentiation from the regulatory changes the EU instated in recent years, and the effect both may have on product quality and time to market.
Post-Brexit, EU and U.K. healthcare product regulations left quite a few manufacturers pondering the viability of releasing new products onto the European market. For any medical device or pharmaceutical company wanting to place new products on the European market, the recent changes mean complying with two separate sets of regulatory and legal requirements, dealing with separate regulatory bodies, and keeping to dual timetables.
To help you keep pace with competitors vying for product authorisations in the U.K. and EU, below you will find a condensed guide to the main terms all health care product manufacturers and quality professionals should know.
Markings: UKCA vs. CE
The approval marking on a product shows it meets safety and quality standards, as well as legal requirements, to be marketed to consumers. For such a small marking, it represents a broad spectrum of life sciences and quality expertise that goes into the development and pre-market auditing of any healthcare product. Post-Brexit, manufacturers will need to add a distinct mark to any product marketed in the U.K. The European Union will continue to require its own separate marking.
UK Conformity Assessed Mark (UKCA)
Marking required on all healthcare products to be sold in the U.K., except for Northern Ireland. Not currently recognised by EU nation-states.
Conformité Européenne, aka European Conformity (CE)
Marking required on all healthcare products to be sold in EU nation states. Not currently recognised by U.K. regulatory agencies.
Rules and Regulations: MDD vs. MDR and IVDR
Safety and quality regulations evolve over time as breakthroughs in life sciences drive regulatory agencies to adapt. Though the pace of progress may always outstrip regulations, it behoves life sciences manufacturers to know and understand which directives their products must comply with in a global region at any one time.
Medical Device Directive (MDD)
Older directives originally instated into law in the EU and U.K. in the 1990s and early 2000s. Though the EU has moved away from the MDD in favour of updated regulations in recent years, with its split from the EU, the U.K. has gone back to following the MDD.
Medical Device Regulations (MDR) and In Vitro Diagnostic Regulation (IVDR)
Current directives instated into EU law, replacing the MDD, including more stringent pre-market audit regulations. Full enforcement is in place as of May 2022.
Governing Bodies: MHRA vs. EMA
Both the EU and U.K. have established governing bodies tasked with upholding the quality regulations and legal requirements set forth by their corresponding directives, along with approving the sale of health care products in their respective regions.
Medicines and Healthcare Products Regulatory Agency (MHRA)
The main regulatory agency for all health care products released on the U.K. market, post-Brexit.
European Medicines Agency (EMA)
While companies' products are regulated at the EU nation-state level, this is the main regulatory agency for all health care products released on the EU market.
More Quality Terms to Know
There are a few more important terms to keep in mind when dealing with EU and U.K. quality regulations. This is by no means an exhaustive list.
Marketing Authorisation
Distinction given to products approved for sale in European regions after meeting specific quality regulations. A product without a marketing authorisation cannot be marketed to consumers in these regions.
Notified Bodies
To be compliant with current EU and U.K. regulations, a pre-market audit of a company's quality system must be performed by an approved third-party agency. Such agencies are known as Notified Bodies (NBs).
Conformity Assessment
An audit performed by an NB to determine if a healthcare product manufacturer meets the respective requirements to release a product on the European market.
UK Responsible Person
A designated company representative present for the completion of a conformity assessment, for companies not based in the U.K.
Next Steps
This is a mere glimpse into the current state of quality regulations for healthcare products in the European region, post-Brexit. For a more in-depth explanation of current EU and U.K. regulatory processes, their effect on medical devices and pharmaceuticals, as well as solutions to common problems manufacturers may experience as they navigate today's regulatory processes, check out MasterControl's industry brief, “How to Navigate UK and EU Quality Regulations in a Post-Brexit World” to learn how your organisation can benefit from an enterprise quality management system (EQMS) explicitly designed to help companies achieve regulatory compliance, visit MasterControl's quality management solutions page.
