UK MHRA and BSI Statements In Response to Brexit Referendum

Dr. David Lim (Dr. Lim)’s Recommendations to the UK’s Health Authority, Medicines and Healthcare products Regulatory Agency (MHRA) and the BSI

To the UK’s MHRA
  • The MHRA should establish its own medical device approval/registration system within the principles of the EU’s medical device regulation or recognize other CE-marked devices available in the EU.
  • Develop a process of recognizing other CE-marked devices
  • Develop its own system for managing clinical trial data and require compulsory requirements to disclose clinical trial data so that it can enforce a maximum level of transparency (T), accountability (A) and responsibility (R).
  • It has to be done in phases in few years, etc.
I hope that the MHRA/UK can (try to) develop the world’s best regulatory system, strongly enforcing TAR.
To the BSI
  • As the BSI must work with the MHRA, I hope the BSI can quickly communicate its plan on how the UK/MHRA’s regulatory system can/may impact to the CE-marked devices through the BSI.
  • Whatever the UK/MHRA adopts a system, the BSI should convince the MHRA to adopt a system without unduly impacting the CE marked devices through the BSI.
  • If impacted, it should be done so in phases, enabling some to transfer to other NBs, etc.
If the UK/MHRA or the BSI needs some advice based on what I have seen from failures or successes, they may contact me.

The MHRA made the following statements, dated June 26, 2016.

The Agency (MHRA)’s response to the outcome of the EU referendum

Following the result of the referendum on the UK’s membership of the European Union, the focus of the Medicines and Healthcare products Regulatory Agency continues to be on our public health role. We will continue to work to the highest levels of excellence and quality, working with and supporting our customers, partners and stakeholders to protect health and improve lives.

Working closely with government we will consider the implications for the work of the Agency. We will continue to make a major contribution globally to improving public health through the effective regulation of medicines and medical devices, underpinned by science and research.

  • Source: MHRA

BSI Statement

Following the result of the UK referendum to leave the EU, there will be a transition period while the UK Government negotiates the terms as a result of the referendum. There are three areas where BSI currently holds important positions as part of the EU and these are as follows:

1.   BSI’s role as the National Standards Body

As the UK’s National Standards Body, BSI will continue to develop and publish British Standards. Our membership of the two international standardization organizations, ISO and IEC, will not be affected where we will continue to play an influential leadership role.

There are three European Standardization Organizations – CEN, CENELEC and ETSI. Our full membership of CEN and CENELEC will continue while the UK Government sets out the arrangements for its withdrawal from the EU. During this transition period, BSI will be working with the UK Government (such as Department of Business, Innovation and Skills) and other parties as appropriate such as European political institutions and European Standardization Organizations regarding its role in the development of the European standardization system. We expect BSI’s membership of ETSI will be unaffected

We will continue to keep you updated on a regular basis as the political situation develops and discussions progress.  For now, it’s business as usual and most importantly, we would like to assure you that BSI will continue to help organizations as we have done for the past 115 years.

2.   BSI’s role as an EU Notified Body for Product Certification

BSI’s role as an EU Notified Body will not change while UK Government sets out the arrangements for its withdrawal from the EU. We anticipate that products already certified and those certified while the negotiations progress, will continue to be accepted by the EU authorities and member states of the EU. During this transition period, BSI will be working closely with the UK Government (such as Department of Business, Innovation and Skills) and UKAS (UK Accreditation Service) to enable BSI to continue being recognized as a Notified Body.

BSI further anticipates it will remain an EU Notified Body for assessing and approving products against the relevant CE directives and regulations (e.g.  Construction Product Regulation, PPE Directive and the Gas Appliance Directive).  There are recognized existing mechanisms in place for non-EU countries to participate, these include the Mutual Recognition Agreements between the EU and America, Canada, Australia, Switzerland and Japan.  Regulatory authorities in these countries designate Notified Bodies to carry out these activities in the same way as member states of the EU.

We will continue to keep you updated on a regular basis as the political situation develops and discussions progress.  For now, it’s business as usual and most importantly, we would like to assure you that BSI will continue to help organizations as we have done for the past 115 years.

3.   BSI’s role as an EU Medical Devices Notified Body

BSI’s role as an EU Notified Body will not change following the recent decision of the EU referendum while the UK Government sets out the arrangements for its withdrawal from the EU. During this transition period, BSI will be working closely with the Medicines and Healthcare products Regulatory Agency (MHRA) to enable BSI to continue being recognized as a Notified Body for Medical Devices.

BSI fully anticipates we will remain a long term major EU Medical Device Notified Body as there are established well recognized existing mechanisms in place for non-EU countries to participate as EU Notified Bodies.  For example, the designated organizations in Norway (under EEA recognition), Switzerland and Australia (through Mutual Recognition Agreements) are recognized as Notified Bodies for the purposes of the relevant EU legislation.

We will continue to keep you updated on a regular basis as the political situation develops and discussions progress.  For now, it’s business as usual and most importantly, we would like to assure you that BSI will continue to provide EU market access as we have done since the inception of the three EU Medical Device Directives.

  • Source: BSI

All management systems training and accredited certification remains unaffected by the outcome of the referendum.

Additional Information

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Brexit with John Oliver

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Last Updated: 2016-06-27

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