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Apply to become an approved manufacturer
Approved manufacturers are manufacturers of weighing and measuring equipment whose quality system has been accredited by a UK Approved Body primarily under the Module D or D1 conformity assessment procedure, as set out in the Non Automatic Weighing Instruments Regulations 2016 (as amended) or Measuring Instruments Regulations 2016 (as amended). Approved manufacturers can complete initial verification of instruments as set out in their accredited quality system.
Some approved manufacturers for the Non-automatic Weighing Instruments Regulations 2016 can have their quality system accredited by a UK Approved Body under Module D or D1 for the purposes of requalification of instruments they have manufactured.
Regulating medical devices in the UK
What you need to do to place a medical device on the Great Britain, Northern Ireland and European Union (EU) markets.
From:
MHRA) is responsible for regulating the UK medical devices market.
This guidance provides information on the UK system, including for:
getting your device certified
MHRA
This guidance is divided into sections on the different rules that apply in Great Britain, Northern Ireland and the EU. Great Britain is England, Wales and Scotland.
For Northern Ireland, different rules apply to those in Great Britain. For more information on the regulatory system for medical devices in Northern Ireland, please see Regulation of medical devices in Northern Ireland below.
16th December 2020
With just two weeks to go until the end of the Brexit transition period on 31 December 2020, there are growing concerns as to what the impact of leaving the EU will be on product labelling and compliance – particularly for CE-marked products. CE is the administrative marking that indicates conformity with health, safety, and environmental protection standards for products sold within the European Economic Area.
The certification of new products will change dramatically post Brexit but many questions still remain. In this article, Nicky Strong of law firm Womble Bond Dickinson, looks to address some of the key areas of concern.