James A. Dunning, Principal, QPC Services LLC04.03.18
Are you ISO 13485 certified by a United Kingdom Notified Body? Perhaps you’re a contract manufacturer serving OEM customers who are certified by a U.K. Notified Body. Either way, medical device companies must start preparing now to mollify the impacts of the United Kingdom’s long-awaited retreat (a.k.a. “Brexit”) from the European Union (EU) next year.
Parting ways with the European single market and customs union could seriously impact medical technology regulation in post-Brexit Europe. Many industry leaders are concerned about potential divergence in the rules governing diagnostics and medical devices, as well as tariffs that could discourage companies from entering new markets. EU-U.K. trade might possibly be affected too, disrupting production and supply chains, particularly those touting “just-in-time” distribution (an approach in which finished goods are only produced and delivered when they are ready to be sold). Any delay to the flow of goods could significantly impact the system.
There is still a considerable amount of uncertainty in the medtech sector about Brexit as the departure date nears. Manufacturers remain unsure about the potential outcome of Brexit negotiations and the subsequent role and authority of U.K. Notified Bodies in CE mark conformity assessments. A January 2018 notice from the European Commission attempts to ease some of this uncertainty by explaining Brexit’s impact on “economic operators,” including medical device companies, Notified Bodies, and Authorized Representatives.
When the United Kingdom officially “secedes” from the EU on March 30, 2019, all previously issued British Notified Body certificates on European regulations and/or directives will become void. That means companies commercializing products in Europe—even those in the United Kingdom—can only do so if they are based in the EU or use an Authorized Representative (AR). Manufacturers who were considered an EU distributor before Brexit will become importers after the withdrawal date.
The notice reads, in part, “According to Union product legislation, the importer is the economic operator established in the Union who places a product from a third country on the Union market. As from the withdrawal date, a manufacturer or importer established in the United Kingdom will no longer be considered as an economic operator established in the Union. As a consequence, an economic operator established in the EU-27 who, prior to the withdrawal date, was considered as an EU distributor will become an importer for the purposes of Union product legislation in relation to product from a third country that this economic operator places on the EU-27 market as from the withdrawal date. This operator will have to comply with specific obligations relevant to an importer, which are different from those of a distributor.”
At this time next year, U.K. Notified Bodies will have lost their status as EU Notified Bodies and no longer will be a part of the European Commission’s information system on notified organizations. Thus, U.K. Notified Bodies won’t be able to perform conformity assessment tasks pursuant to EU product legislation.
Companies that have certificates from U.K. Notified Bodies and plan to market their products in Europe are advised in the Commission’s notice to either apply for a new certificate from an EU-27 Notified Body or arrange for a transfer of the file and corresponding certificate(s) to an EU-27 Notified Body, which will assume responsibility for the certificate(s).
“When the applicable conformity assessment procedure requires or provides for the possibility of third party intervention, a certificate delivered by a body recognized as an EU Notified Body at the time of the placing of that product on the market will be required for products placed on the [European] market as from the withdrawal date,” the Commission’s notice states.
These guidelines, of course, are subject to change, as negotiations between the United Kingdom and EU are ongoing. U.K. Prime Minister Theresa May is certainly interested in protecting the interest of the country’s Notified Bodies, so it is possible the final agreement allows U.K. Notified Bodies to continue issuing certificates. Regardless of the outcome, however, certified companies should be communicating with their respective Notified Bodies. A word of advice: Plan for the worst and hope for the best.
Some additional factors to consider:
Contract manufacturers should talk to their OEM customers about Brexit, because those strategies could significantly impact them. Hope is not a strategy. In the plan-do-check-act cycle, it is certainly time to plan. Companies do not want to be caught off-guard by suddenly discovering their Notified Body cannot serve them post-Brexit. Manufacturers also must be prepared to choose a Notified Body if necessary and implement a plan to do so.
Going against my own advice, I hope U.K. Notified Bodies will continue to serve medtech customers without much disruption. However, business doesn’t just happen, and the industry must be prepared in case these Bodies cannot continue to serve medtech business needs. Companies that don’t already have a strategy for Brexit should make one. Fast.
James A. “Jim” Dunning’s consulting career began in 2001. He has provided quality and regulatory consulting services for various companies ranging from Fortune 500 medical device firms to startups. Dunning’s passion, however, lies with startups and small companies, especially those in regulatory distress. He has amassed significant experience in preparing 510(k) applications, developing complete Quality Management Systems, providing Quality System Training, and advising on quality, business, and leadership issues. Dunning is a senior member of the American Society for Quality (ASQ) and a member of the Regulatory Affairs Professional Society (RAPS). He can be reached at jdunning@qpcservices.com.
Parting ways with the European single market and customs union could seriously impact medical technology regulation in post-Brexit Europe. Many industry leaders are concerned about potential divergence in the rules governing diagnostics and medical devices, as well as tariffs that could discourage companies from entering new markets. EU-U.K. trade might possibly be affected too, disrupting production and supply chains, particularly those touting “just-in-time” distribution (an approach in which finished goods are only produced and delivered when they are ready to be sold). Any delay to the flow of goods could significantly impact the system.
There is still a considerable amount of uncertainty in the medtech sector about Brexit as the departure date nears. Manufacturers remain unsure about the potential outcome of Brexit negotiations and the subsequent role and authority of U.K. Notified Bodies in CE mark conformity assessments. A January 2018 notice from the European Commission attempts to ease some of this uncertainty by explaining Brexit’s impact on “economic operators,” including medical device companies, Notified Bodies, and Authorized Representatives.
When the United Kingdom officially “secedes” from the EU on March 30, 2019, all previously issued British Notified Body certificates on European regulations and/or directives will become void. That means companies commercializing products in Europe—even those in the United Kingdom—can only do so if they are based in the EU or use an Authorized Representative (AR). Manufacturers who were considered an EU distributor before Brexit will become importers after the withdrawal date.
The notice reads, in part, “According to Union product legislation, the importer is the economic operator established in the Union who places a product from a third country on the Union market. As from the withdrawal date, a manufacturer or importer established in the United Kingdom will no longer be considered as an economic operator established in the Union. As a consequence, an economic operator established in the EU-27 who, prior to the withdrawal date, was considered as an EU distributor will become an importer for the purposes of Union product legislation in relation to product from a third country that this economic operator places on the EU-27 market as from the withdrawal date. This operator will have to comply with specific obligations relevant to an importer, which are different from those of a distributor.”
At this time next year, U.K. Notified Bodies will have lost their status as EU Notified Bodies and no longer will be a part of the European Commission’s information system on notified organizations. Thus, U.K. Notified Bodies won’t be able to perform conformity assessment tasks pursuant to EU product legislation.
Companies that have certificates from U.K. Notified Bodies and plan to market their products in Europe are advised in the Commission’s notice to either apply for a new certificate from an EU-27 Notified Body or arrange for a transfer of the file and corresponding certificate(s) to an EU-27 Notified Body, which will assume responsibility for the certificate(s).
“When the applicable conformity assessment procedure requires or provides for the possibility of third party intervention, a certificate delivered by a body recognized as an EU Notified Body at the time of the placing of that product on the market will be required for products placed on the [European] market as from the withdrawal date,” the Commission’s notice states.
These guidelines, of course, are subject to change, as negotiations between the United Kingdom and EU are ongoing. U.K. Prime Minister Theresa May is certainly interested in protecting the interest of the country’s Notified Bodies, so it is possible the final agreement allows U.K. Notified Bodies to continue issuing certificates. Regardless of the outcome, however, certified companies should be communicating with their respective Notified Bodies. A word of advice: Plan for the worst and hope for the best.
Some additional factors to consider:
- Since Notified Bodies will most definitely stay abreast of this issue, they will have the best and most up-to-date information. Don’t hesitate to reach out to these entities; communication is crucial.
- Monitor EU communications on this issue. Brexit negotiations are ongoing.
- Realize there is not much time to avoid a disruption. Acquiring a new certificate from an EU-27 Notified Body will take time. With ISO 13485:2016, transition to the new Medical Device Regulations, and the Medical Device Single Audit Program, Notified Bodies all have full schedules. The initial engagement may take more time and be more complicated than previously imagined.
- Don’t switch Notified Bodies. Familiarity has its advantages, though this may not ultimately be possible.
Contract manufacturers should talk to their OEM customers about Brexit, because those strategies could significantly impact them. Hope is not a strategy. In the plan-do-check-act cycle, it is certainly time to plan. Companies do not want to be caught off-guard by suddenly discovering their Notified Body cannot serve them post-Brexit. Manufacturers also must be prepared to choose a Notified Body if necessary and implement a plan to do so.
Going against my own advice, I hope U.K. Notified Bodies will continue to serve medtech customers without much disruption. However, business doesn’t just happen, and the industry must be prepared in case these Bodies cannot continue to serve medtech business needs. Companies that don’t already have a strategy for Brexit should make one. Fast.
James A. “Jim” Dunning’s consulting career began in 2001. He has provided quality and regulatory consulting services for various companies ranging from Fortune 500 medical device firms to startups. Dunning’s passion, however, lies with startups and small companies, especially those in regulatory distress. He has amassed significant experience in preparing 510(k) applications, developing complete Quality Management Systems, providing Quality System Training, and advising on quality, business, and leadership issues. Dunning is a senior member of the American Society for Quality (ASQ) and a member of the Regulatory Affairs Professional Society (RAPS). He can be reached at jdunning@qpcservices.com.
