YellowQCPro
Involved In Discussions
Hello Elsmar!
Thank you in advance for helping to give me some knowledge regarding the topic of Switzerland and EU's Mutual Recognition Agreement and the need to revise prior to the MDR go date!
I'll try to keep this short, please ask questions if I'm not clear.
Since June 1, 2002, Swiss and EU manufacturers have enjoyed the benefits of mutual recognition through the Agreement between the Swiss Confederation and the European Community on mutual recognition in relation to conformity assessment (EU-Switzerland MRA). The EU-Switzerland MRA significantly helps to reduce technical barriers to trade for Swiss and EU exporters, effectively ensuring the harmonization and equivalence of the regulations of both jurisdictions and eliminating the need for companies to conduct conformity assessments twice (Swiss Medical Devices Manufacturers to Be Blocked by Missing Framework Agreement? - Lexology).
Today, there is some uncertainty that the MRA will be updated or if Switzerland will be required to meet the requirements of a third country in order to be permitted to export products to the EU in accordance with the new EU MDR.
My assessment, although limited in scope, highlights the following changes that have the potential to be impacted without the MRA:
· There would be no time for a Swiss NB to become MDR designated per Chapter IV of the MDR
· Swiss manf. Must have an authorized rep (AR)
· Swiss manf. Must have a person responsible for regulatory compliance (PRRC)
· Update to the QMS pertaining to distribution
· Potential duplication of clinical trials
· adaptation of updated product labels (AR)
Swiss manufacturers
· Appoint an AR with a PRRC that is independent of that manufacturer and based in the EU;
· Appoint an importer;
· Change labels and/or packaging so the details of the AR and the importer are presented in line with the MDR requirements.
Does anyone in the forum have more information or direction that they could provide to me? I am hoping for a successful renewal of the MRA which would alleviate additional work out of the scope of the already massive undertaking of becoming EU MDR compliant.
I should mention that the role my company play regarding Switzerland Medical Device Compliance is EU Rep., importer, manufacturer and distributor. Thank you in advance for the help and I welcome and discussion or helpful information to help guide the companies that are facing this challenge to a swift, compliant solution.
Happy Wednesday!
Thank you in advance for helping to give me some knowledge regarding the topic of Switzerland and EU's Mutual Recognition Agreement and the need to revise prior to the MDR go date!
I'll try to keep this short, please ask questions if I'm not clear.
Since June 1, 2002, Swiss and EU manufacturers have enjoyed the benefits of mutual recognition through the Agreement between the Swiss Confederation and the European Community on mutual recognition in relation to conformity assessment (EU-Switzerland MRA). The EU-Switzerland MRA significantly helps to reduce technical barriers to trade for Swiss and EU exporters, effectively ensuring the harmonization and equivalence of the regulations of both jurisdictions and eliminating the need for companies to conduct conformity assessments twice (Swiss Medical Devices Manufacturers to Be Blocked by Missing Framework Agreement? - Lexology).
Today, there is some uncertainty that the MRA will be updated or if Switzerland will be required to meet the requirements of a third country in order to be permitted to export products to the EU in accordance with the new EU MDR.
My assessment, although limited in scope, highlights the following changes that have the potential to be impacted without the MRA:
· There would be no time for a Swiss NB to become MDR designated per Chapter IV of the MDR
· Swiss manf. Must have an authorized rep (AR)
· Swiss manf. Must have a person responsible for regulatory compliance (PRRC)
· Update to the QMS pertaining to distribution
· Potential duplication of clinical trials
· adaptation of updated product labels (AR)
Swiss manufacturers
· Appoint an AR with a PRRC that is independent of that manufacturer and based in the EU;
· Appoint an importer;
· Change labels and/or packaging so the details of the AR and the importer are presented in line with the MDR requirements.
Does anyone in the forum have more information or direction that they could provide to me? I am hoping for a successful renewal of the MRA which would alleviate additional work out of the scope of the already massive undertaking of becoming EU MDR compliant.
I should mention that the role my company play regarding Switzerland Medical Device Compliance is EU Rep., importer, manufacturer and distributor. Thank you in advance for the help and I welcome and discussion or helpful information to help guide the companies that are facing this challenge to a swift, compliant solution.
Happy Wednesday!
