GRS Blog

European Medical Device Regulations - So What's New?

02/11/2013

The EU Commission voted on the proposed new Regulations on 22 October 2013 on the same day as the BSI Consultants' Day, so you could say it was a "Hot Topic"!

Our immediate comments are:

• Concern about the reprocessing devices.
• MedTech companies are required to have a person responsible for regulatory compliance within the company (definition of "within" to be clarified NB a similar role within Pharma is very often outsourced i.e. Qualified Person for GMP, Pharmacovigilance).
• Involvement of the EMA is to be more restricted than originally proposed.
• The concept of Special Notified Bodies (SNBs) has been agreed in order to conduct conformity assessments of high risk devices.
• Unannounced visits on a 3 year cycle to be enforced (more frequently if high risk or compliance is compromised) and will include visits to "critical subcontractors".
• There were lots of empty seats which seems to imply that there is some Council disagreement with some of the proposals.  In which case it is probably unlikely that a compromise agreement will be reached before next April which will delay implementation of the new regulations.
• Public access to clinical data.
• More emphasis on clinical evaluation and investigations.
• Clinical evaluation to continue throughout the life cycle of the product and therefore the technical file will be a 'living' document.
• Transition period for IVDs to comply with new regulation has been reduced from 5 to 3 years (but this may change?).
• Many IVDs will need to be re-classified.
•  

The new regulations should provide a more level playing field, the Notified Bodies themselves will be more regulated and compliance will be enforced.  One good example of this last point is that unannounced visits have always been around but have never been implemented.  The new regulation requires that these will now actually take place! 

It is more than likely that the manufacturers/MedTech companies themselves will see the increase in 'red tape' leading to longer timescales to market and therefore, increased costs.  It may be difficult for them to see any benefits, certainly in the short to medium term.

In brief there is quite a bit of work to do for both MedTech companies and the Notified Bodies.  If MedTech companies are fully compliant with current regulations/directives then it should be a smoother transition but … many are not! 

The key message is to start preparing now and, of course, Global Regulatory Services (GRS) can help!

Author: Greer Deal, Director of Global Regulatory Services