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The Medical Device Revisions

March 2013 

Time for Change

The Medical Device Directive [1] is clearly getting ‘long-in-the-tooth’.  Product development by the Industry has progressed immeasurably over the last 20 years since its first publication in the EU’s Official Journal to now include technologies such as nanotechnologies, stand-alone software, tissue engineering and micro-electronics to name but four. 

Despite the revision [2] in 2007, the current regulatory scheme is coming under increasing strain, as the CE Mark originally intended for traditional devices such as dressings and implants, struggles to include these new technologies.

At the same time that technology development accelerates, so has the public perception and understanding of medical devices.  The surgeon, nurse and patient have more product related information at his or her fingertips through the Internet, newspapers and published literature, than ever before.

Because of recognition of these misgivings, steps were initiated by the European Commission more than two years ago, to consider what the new iteration of the Medical Device Directive should look like, resulting in the proposal for regulation 2012/0266 (COD), published in September 2012 [3].  Events of 2012 however, particularly the scandal involving PIP breast implants [4] and ‘Metal-on-Metal’ partial hip replacements [5] have accelerated these plans.

But what do these changes include and what do they mean to the Medical Device manufacturer? 

Main Highlights

Although there are many changes within the new proposed revisions, the fundamental ‘New Approach’ for the regulation of medical devices remains.  This therefore means that the principles of Essential Requirements, harmonised standards, Conformity Assessment and Company ‘Declarations of Conformity’, are not going to give way to more prescriptive pharmaceutical style regulation and licensing.

Having said this, the Governmental and public clamour for resolution to the 2012 scandals, has resulted in some aspects appearing to take on a more pharmaceutical feel, as well as ensuring that some features of the revisions are to be fast-tracked for approval.

The main highlights are:

  • Greater Notified Body and Company control through auditing, including the provision for Notified Bodies to carry out un-announced audits of manufacturers. This has already commenced in some product sectors, with Notified Bodies requesting access to manufacturing areas even during the tail end of 2012.  This is clearly a response to the issues associated with the PIP breast implants, but will need fine-tuning with ongoing experience.
  • Pre-Market review of certain Class III Design Dossier summaries by Competent Authorities prior to affixing of CE Marks. Could this possibly be the start of a more pharmaceutical style approval process, by ensuring the Governments have the final say for CE Marking?  It is arguable that this ‘Pre-Market Approval’ process will only lengthen time to market for more innovative products, whilst adding little to their safety profiles.
  • Stronger control on Third Party Distributors, Economic Operators and Authorised Representatives. Traceability of medical devices throughout the EU marketplace was noted as a failing within the PIP story.  Often Companies are unaware as to where and how their products are marketed throughout the Common Market – not critical for more traditional products perhaps, but a serious problem for higher risk implants.  Manufacturers are therefore going to have to fully understand their distribution chains, and those Third Parties they employ will be more legally accountable for the products they sell.
  • Increased Post-Marketing Surveillance awareness, vigilance reporting and the commissioning of a European-wide traceability and reporting database. The database to cover these aspects has been mooted for several years, but is finally overcoming technical issues and is likely to be operational within the next 12 months.
  • Manufacturers, Authorised Representatives and Economic Operators will have to have ‘Qualified Persons’ to effectively approve products onto the European market. The role of this Qualified Person has yet to be finalised, but this is a clear reference to the pharmaceutical industry, whereby the position will be legally responsible for the product once marketed.
  • Unique Device Identifiers will form part of the overall plans for improved traceability. The requirement for a device to be marked with a UDI, of yet undefined format, should not be underestimated both from a technical and financial aspects.  


This short paper only highlights those areas earmarked for revision within the medical device directive that are currently occupying most discussion space within Trade Association and European Commission communications.  These discussions are ongoing, but timelines suggest that some items, such as Distribution, Post-Marketing Surveillance requirements and Notified Body controls have more priority over the other points and could well be enforced within the next 12 to 18 months.

The next paper in this short series will concentrate on the Authorised Representative and Economic Operators and their role in improving traceability and post-market surveillance.

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[1] Council Directive 93/42/EEC of 14 June 1993, concerning Medical Devices (OJ L 169, 12.7.1993, p1)

[2] Council Directive 2007/47/EC of 5 September 2007, amending … Directive 93/42/EEC

[3] http://ec.europa.eu/health/medical-devices/documents/revision/index_en.htm

[4] http://www.bbc.co.uk/news/health-18057761 

[5] http://www.mhra.gov.uk/Safetyinformation/Generalsafetyinformationandadvice/Product-specificinformationandadvice/Product-specificinformationandadvice%E2%80%93M%E2%80%93T/Metal-on-metalhipimplants/index.htm

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John Leger has been married for 26 years and has six children.  He is a self-taught web developer who spends a lot of time learning new technologies and sharpening his skills.  His ability to learn new things quickly has enabled him to skillfully play the guitar, keyboard, flute and bass.  In his off time, he loves to hunt and ski.  He’s holds a black belt in classic Chung Do Kwon Taewkondo and is the lead instructor at Northshore Taekwondo Academy in his home town.


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