Welcome to our Devices regulatory news section.
This section provides the latest information about the regulation of devices.
Latest devices regulatory news
07 May 2014 | New restrictions on the use of certain hazardous substances in electrical and electronic equipment (RoHS) requirements
In June 2011, the recast of the RoHS Directive (2002/95/EC) was published in the Official Journal as Directive 2011/65/EU (RoHS II). One of the main requirements of RoHS II is to restrict six hazardous substances in electrical and electronic equipment.
19 Mar 2014 | Medical device stand-alone software (including apps)
The MHRA has today published guidance on medical device stand-alone software (including apps).
30 Jul 2013 | Proposal for new European regulations aimed at improving consumer product safety and the functioning of the European internal market through market surveillance
The Department for Business Innovation and Skills (BIS) have published a consultation seeking views on the European Commission's proposals for two new European device regulations.
The MHRA seeks your views on the EC Regulation on electronic instructions for use of medical devices.
The European Commission is looking for medical devices experts with at least six years of professional experience to work on policy, audits, inspections, and evaluation.
The MHRA is seeking views on its approach to implementing into UK law the Commission Regulations 722/2012 on animal tissues and Commission Regulation 207/2012 on e-labelling.
04 Apr 2013 | MHRA response to the public consultation on the revision of European legislation on medical devices
The MHRA has published its analysis of the evidence received from healthcare professionals, patients, industry, academics, and the interested public on the draft new European legislation on medical devices.
21 Mar 2013 | MHRA Easter opening times 2013
Opening times for the MHRA over the Easter period.
30 Jan 2013 | European Commission consultation on how to reform the internal market for industrial products
The European Commission has published a questionnaire to gather views on how to complete the European Union's internal market for manufactured non-food products.
09 Jan 2013 | Guidance on EU Commission Regulation 207/2012 on electronic labelling of medical devices
Guidance on EU Commission Regulation 207/2012 on electronic instruction for use of medical devices.