Learning Marketplace

The Future of Standards in Europe - harmonization and other recognitions of standards

A standard is an agreed way of doing something. This could be making products, managing processes, delivering services or supplying materials. Standards cover many activities undertaken by organizations and used by their customers.

Standards are the distilled wisdom of subject matter experts who know the needs of the organizations they represent, such as manufacturers, sellers, buyers, customers, trade associations or regulators.

A harmonized standard is a European standard developed by a recognized European Standards Organization: CEN, CENELEC or ETSI, created following a request from the European Commission. Manufacturers, economic operators or conformity assessment bodies use harmonized standards to demonstrate that products, services or processes comply with EU legislation.

On September 26, 2012 the EU Commission released its proposal for future regulation of medical devices. The current three Directives on active implantable medical devices (AIMD), medical devices (MDD) and in-vitro diagnostic medical devices (IVDD) are replaced by two Regulations, one covering all medical devices, the other covering IVDs. Both Regulations are in the final stages of the legislative procedure and are expected in 2016, allowing them to come into effect by the end of 2016, or early 2017.

New to the MDR is the instrument of Common Specifications (CS). These can be adopted by implementing acts where no harmonized standards exist or where relevant harmonized standards are not sufficient. They can be adopted in respect of the general safety and performance requirements in Annex I, technical documentation in Annex II, clinical evaluation and post-market clinical follow-up (PMCF) in Annex XIII or the requirements of clinical investigation in Annex XIV. The new mechanism of CS will be used to provide design requirements for Annex XV products.

This webinar will discuss how the introduction of CS sits with harmonized standards and how organizations can utilize both to maximum effect.


Paul Sim has worked in the healthcare industry for 34 years and is currently Project Managing BSI's implementation of EU Commission Recommendation 2013/473/EU dealing with Unannounced Audits. Joining BSI in August 2010, Paul led the BSI effort to implement the Saudi Food & Drug Administration Medical Device Interim Regulations. Previously he held senior RAQA leadership positions at Spacelabs Healthcare, Teleflex Medical, Smiths Medical and Ohmeda.

Paul has Medical Device experience across a very broad range of devices including: anesthesia systems, patient monitors, respiratory care devices, devices for re-use, infant warmers, incubators, sterilizers, autoclaves, infusion pumps and associated disposables, urinary catheters, surgical instruments and diagnostic cardiology.

Paul has compiled articles for publication in various publications, presents at conferences and is a Module Advisor at Cranfield University on a Master's program dealing with Regulatory Affairs for Medical devices