In my time working in Regulatory Affairs Recruitment on a Consultant or Contract basis I find myself helping companies who have let a problem or a deadline get out of hand or behind of where they projected it to be and subsequently finding the consultant who can put this back on track. It happens in all aspects of life and in the world of Regulatory Affairs it happens consistently, whether it be Agency meetings, waiting for Clinical Data for submissions or a the general life cycle of product development.
In the Medical Device world however there has been a deadline which has been looming for a while and the deadline is increasingly looking like it won’t be pushed, as it was before! This of course is the EU MDR deadline at the end of May 2021. So what is EU MDR. Let me explain for the casual reader who has found their way onto this blog of mine and anyone else who may be interested.
European Medical Device Regulation (MDR) is a new set of regulations that governs the production and distribution of medical devices in Europe, and compliance with the regulation is mandatory for medical device companies that want to sell their products in the European marketplace. Sounds simple? Not quite, if your company was compliant with the Medical Devices Directive (MDD), don’t think your EU MDR compliant the MDR represents brand new regulations with a host of changes.
This brings us to why? Europe is full of Medical Device products in Class 1,2 and 3 with majority meeting CE Markings. To the regular citizen this change will be behind closed doors and it certainly won’t make the 10 o’clock news. There were many reasons the MDD needed to be updated one being how they didn’t reflect the change in products being developed and the change in technology since MDD was brought in.
MDD came into law in 1992, software as a medical device (SaMD) did not yet exist. Software was something that controlled electronic machines, now we have diagnostic devices which provide real time data and analysis to a doctor and the patient themselves via their smartphone!
Why is the transition a big deal for companies however? They had been given time to prepare and get compliant? Well, one section that caused a stir is Annex XVI, there 16 sections overall. Why did it cause a stir? Annex XVI has made products that are covered under MDRs guidelines that were previously not considered Medical Device have become Medical Devices, which as you can imagine for a Pharmaceutical/Biotech who has never had to follow Medical Device regulations this would have come as a shock.
Annex XVI mandates that the following groups of products comply with the requirements of the MDR:
• Contact lenses and other products used in or on the eye (eye drops and cosmetic contact lenses would be included here)
• Products introduced into the body via surgically invasive means to modify the anatomy (silicon breast implants would now qualify here)
• Products and substances used for facial or other subcutaneous fillings
• Equipment used for liposuction, lipolysis, or lipoplasty
• High-intensity radiation equipment used for tattoo and hair removal
• Equipment using electrical or magnetic currents to stimulate the brain
This is only a few but as you can imagine with the extent of the changes more products are being reclassified.
So why have some Medical Device companies struggled? Put simply to become compliant cost time, money and hard work. On the money side of business COVID-19 has made revenue generation harder for Medical Device companies meaning for most consulting help has been too expensive.
The deadline was set for May 2020 but as mentioned this was pushed to 2021 to allow more time. May is around the corner and we are now in what we call Crunch Time and is where I and Barrington James can help. Barrington James are one the world’s only Life Sciences dedicated Staffing Agencies with each vertical such as Regulatory Affairs, Quality Assurance, Clinical, Medical, Finance etc are covered by experienced and knowledgeable consultants for Contract and Permanent basis’s. Offices in New York, North Carolina, London, Singapore and most recently Japan give us a global reach and network of candidates meaning we are well suited and ready to assist with your needs on a global scale.
Get in touch on Charman@barringtonjames.com for more information or call on 646-415-8221 for an introductory call as I would relish helping your company reach its goals and if I can’t assist you one of my colleagues most certainly can.
Regulatory Affairs – U.S Contract Consultant