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The Changing Landscape of European Medical Device Regulations

Patrick D. Mize, Ph.D.  linkedin small logo
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Advisor: Product Development / Regulatory Services


Marketing a Medical Device or an IVD in the European Union is gated by the assembly of the Technical File and conformity assessment [either self-assessment or through an NB, Notified Body] for the conformity information. Regardless of type or classification, a medical device’s technical documentation is an integral part of its regulatory approval.

The type of technical information included varies depending on the conformity assessment route and classification of the medical device, but the technical documentation is the main evidence of a device’s compliance to the Essential Requirements for either the Medical Device Directive [MDD] or the In Vitro Diagnostics Directive [IVDD]. Clinical evaluation is an ongoing process conducted throughout the life cycle of a medical device. Regulatory requirements mandate that the Technical File and the Clinical Evaluation Report [CER] are updated on a regular basis.

The CER, which is included in your Technical File or Design Dossier, is required when bringing a medical device to market and helps demonstrate that the device achieves the intended purposes while minimizing any anticipated risks and foreseeable adverse events and conforms to the relevant Essential Requirements of the Medical Directives. The CER summarizes design characteristics, risk evaluation and mitigation, performance and pre-clinical testing of the device, literature reviews / references, clinical trial results, internal CAPA information and post-launch surveillance data.

This compilation provides objective evidence that the device conforms to the relevant Medical Device Directive both at launch and during post-market clinical follow up. Upcoming revisions of the Medical Device Regulations will stress the central role of the Clinical Evaluation Report [CER] in the technical documentation.

Regulatory Background

The European Community regularly updates the requirements for marketing medical devices in the European Union [EU]. Because of the number of safety incidents and adverse events with metal-on-metal hip implants, silicone breast implants, transvaginal mesh, and IUD medical devices, manufacturers and Notified Bodies [NBs] are under increased pressure to improve public safety.

Historically, the EU harmonized the rules governing the safety and effectiveness (performance) of Medical Devices in the 1990s. Three Medical Device Directives (MDDs) formed the core legal framework:

  • Directive 90/385/EEC for active implantable medical devices 1;
  • Directive 93/42/EEC for general medical devices2 (CERs are mandatory for CE marked medical devices in all four classes: class I, class IIA, class IIB, and class III); and
  • Directive 98/79/EC for in vitro diagnostic medical devices.3,4
  4. Directive 98/79/EC for in vitro diagnostic medical devices is not the focus of the revisions concerning the need for a Clinical Evaluation Report as such for implantable and general Medical Devices, but all the elements of the CER are to be addressed in the Essential Requirements in Annex I of the IVDD Directive.


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RMH BWRichard M. Hahn, Senior Marketing and Creative Director

Today’s 24-hour news cycle can place an individual, business or brand at risk at the slightest hint of controversy or legal problem. Acting swiftly to prevent a crisis from deepening is imperative. You must take control and manage the message in a cool, confident manner. What you do – or don’t do – in those first critical hours can be the difference between saving your reputation or inflicting irreparable harm. Think BP. Think FEMA. And, most recently, Volkswagen.

During a crisis you must act in a manner that helps quell rumors, maintains confidence among customers, vendors, employees and board members, as well as shapes public opinion.  Unless you act quickly and appropriately, your business and brand reputation, and the character and veracity of your leadership team can all be placed in jeopardy.

Long before an issue comes to a conclusion, positive or negative, business associates, employees, customers, as well as the public at large often pass judgment on the party in question based on news reports, websites, online blogs or the rumor mill.  Acting quickly and smartly, it’s possible to influence the way a story is told and conceivable to alter the outcome of that story.  You have the power to control the message–or at least minimize the damage–in most situations.


Brand-Saving Strategies

Issues such as adherence to regulations, employee lawsuits, product recall, and leadership behavior are just a few of the nightmares that call for well-prepared strategic communications protocols, not knee-jerk reactions.   Here is what needs to be done in most every situation:

  1. Assign one–and only one–spokesperson to make statements and answer questions.
  2. Develop clear talking points and protocols.
  3. Create a well-crafted press release and send it to the appropriate media.
  4. Hold a media event allowing you to control the message.
  5. Meet with employees and board members to quash unfounded rumors.
  6. Keep customers and vendors informed of the situation.
  7. Control 0nline SEO management to minimize negative search engine hits.
  8. Maximize reach through social media.


“No Comment”

This is not a prudent response to a question about the problem.  The perception will be that you have got to be hiding something.  Plus, you will look guilty as hell on the six-o’clock news.  The best thing to do if the media jumps all over you before a response protocol has been established is to say you are…”Still sifting through all the details and will be making a formal statement tomorrow at 3:00 pm.”


Be Proactive

At our marketing firm we develop marketing plans for all types of businesses and organizations. Beyond the required strategies such as branding, public relations, advertising and online communications we normally insist upon a crisis management strategy that clearly lays out the modus operandi when a problem arises.  Chain of communication, selected media contacts, customer and vendor contacts, and employee communications are all included.

If you don’t have such a plan, you should consider one immediately and ensure key members of your organization are aware of it.

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RMH BWRichard M. Hahn, Senior Marketing and Creative Director

I just received a USPS-delivered newsletter from a company, a B2B firm I like with a wonderful reputation and quality services.  But this newsletter was a real ‘brand buster’ in my estimation.

The writer had to be paid by the word; it was wall-to-wall text formatted into James Joyce-length paragraphs and very few photos. No way in the world I have the time or inclination to muddle through this disaster.

Many marketing directors still don’t get it. They continue to cram as much copy into a website, newsletter or sales sheet as possible believing that they need to tell the entire story in minute detail to generate interest. In the famous words of a Cleveland resident interviewed on TV–“Who got time for that?”

This is the age of speed dating and the elevator pitch; the 140-character Twitter post, emoticons, acronyms and abbreviations.


• Just tell the story

• Rewrite. Edit  (Repeat)

• Use photos

• Tighten up paragraphs

• Worship white space

• Use bullet points

• Attach video links to your e-marketing pieces

In the interest of practicing what I preach…


Contact BioAlliance Strategies

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Jared Byer pic copyJared Byer, MBA – Managing Director

Five Steps to Creating a Successful Marketing Program for an Emerging Business

Businesses that want to thrive understand the need to develop effective marketing programs.

Unfortunately for some business owners, understanding the importance of “doing” marketing differs from understanding how to build a cost-effective program that works.

Here are the five proven elements of the marketing programs BioAlliance Strategies builds for our clients.

  1. Know your market. Who wants, needs, likes your products or services?
  2. Differentiate yourself from your competitors. Hint: Focus on value-based characteristics that will be valued by your market.
  3. Create messages that appeal to your market.
  4. Deliver messages at a regular, predictable cadence.
  5. Focus on a person-to-person meeting.

For more information on our capabilities, Contact Us

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Ayd pic copyPatrick R. Ayd, BSN, MBA

Advisor: Clinical Sites

One of the biggest problems I encounter is related to training and training documentation.  When you look at the delegation of duties log and see what tasks have been delegated to whom the first question that you should ask yourself is “does this person have training specific to this task” and “is the training the individual received documented”.  For example purposes let’s look at the delegated task of Investigational Product (IP)/Drug administration.  Training comes in a variety of ways.  Training could simply be from someone’s baseline education.  As an example, a Registered Nurse has been well trained in the administration of medication and has passed the licensing exam to become an RN.  Because of this, there is no need to have additional documentation (other than a copy of their license) related to medication administration in their training file.  Yet, you take the same task and delegate it to a clinical research coordinator that is not a licensed nurse and in this case, you must have documentation in the clinical research coordinator’s training file that they have been trained to administer medication.

To simplify things I believe that there are two types of training documentation, study/trial specific training and non-study/trial specific training (CPR, fire egress, etc.).  All trial specific training documentation should be kept with the trial documentation and should not be duplicated and kept in your employee’s training file.   You should keep a training file for each employee where you maintain all non-trial specific training documentation such as CPR, ACLS, fire egress, etc.

For more information and to speak with Patrick, Contact Us

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JJS brick wall background copyIn Social Media Examiner’s 2013 End of Year Report, marketers now place very high value on social media marketing:

  • 86% of marketers stated that social media is important for their business
  • 89% of marketers stated that increased exposure was the number one benefit of social media marketing

These are the definitive benefits of social media marketing that are listed:

  • Increased exposure
  • Increased traffic
  • Developed loyal fans
  • Generated leads
  • Improved search ranking
  • Grew business partnerships
  • Reduced marketing expenses
  • Improved sales
  • Provided marketplace insight

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Patrick R. Ayd, BSN, MBA – Advisor, Clinical Sites

Quality Control (QC) in clinical research facilities can simply mean that documented data (or data found to be missing) has had at least two sets of eyes review the data for correctness and completion.  The end result of a good QC system/process is having good clean data in a timely manner which is one of the primary goals in a clinical research trial.

One of the issues I find during our site audits is that the QC system is not a “formal” process followed on a consistent basis or there is no documentation that a document has received a QC review.  Another common mistake is that one person is given the responsibility to QC all documents which turns out to be a next to impossible expectation.  Your entire staff should have a role in the QC process which should be completed prior to data entry.  When involving other staff, you give that staff member an incentive to double check their own work knowing that someone else will be looking at their work.

Make sure that your QC process is clearly documented and your staff is well trained with your Quality Control process.  There is a significant difference between Quality Control and Quality Assurance.  Stay tuned for more information related to QA or Quality Assurance.

To consult with Patrick Ayd, please contact: