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
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