NEW MEDICAL DEVICE REGULATION : Implications for Medical Device Manufacturers
TAGS: Pepgra | Medical Device Rep orting | Medical Device Clinical Research monitoring | Global Regulatory Writing | Patient Recruitment | Data Management | Post Market Surveillance
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BACKGROUN D
The i m p l e m e n t a t i o n of t h e n e w Medical Device Regulations (MDR) o n 25t h May, 2017 has pr esen ted m e d i c a l device man uf a ct u rers w i t h several drastic changes i n t h e decades o l d regulatory f r a m e w o r k of t h e European Union (EU). The n e w M D R has effectively replaced t h e previous m e d i c a l device directive (93/42/EEC) of t h e EU a n d also t h e directives relating t o active i m p l a n t a b l e m e d i c a l devices (90/385/EEC). The n e w M D R offered m e d i c a l device ma nu f ac t urers w i t h already a p p r o v e d devices i n t h e m a r k e t w i t h a c o m p l i a n c e t i m e of t hre e years till 2 6 t h May, 2020. For certain m e d i c a l device manufacturers, t h e n e w M D R offered extra t i m e f o l l o w i n g t h e d a t e of a p p l ic a t i o n w h i c h enables t h e m t o provide n e w p r o d u c t s t o t h e m e d i c a l device m a r k e t for a m a x i m u m e x t e n d e d t i m e of four years. However, in this case, extra r e q u i r e m e n t s w o u l d b e app lica ble for this a d d it i o n a l p e r i o d of transition.
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Objective of the New MDR The key objectives of n e w M D R t o m a k e a t w o d i m e n s i o n a l i mp a c t i n e n h a n c i n g t h e safety of m e d i c a l devices (Laege M i d d l e Styrelsen, 2019) are: Reinforcing t h e rules associated w i t h p l ac i n g n e w m e d i c a l devices w i t h i n t h e market. Increasing surveillance pos t t h e device’s availability i n t h e market.
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Implications of the New MDR for Medical Device Manufacturers The new MDR warrants the need for conclusive and hard evidence that is based on data for existing as well as new medical devices (Lehmann, 2019). Implications are: Setup systems for managing quality and risk. Consistently gather clinical evidence for their devices following its market release, to validate the effectiveness as well as safety of the device. Provide data reports on a new Centralized Electronic System which will be easily available to the public. Be responsible for determining devices that requires reclassification and those that require additional review by a notified body. Setup systems that encompass their financial obligations in the event of unwarranted harm that arises from a defective device. With the new MDR in force, the objective is to reinforce the rules associated with clinical investigation of medical devices, with a view to improve availability ofRegulatory valid clinical information. Clinical Research the monitoring | Global Writing | Patient Recruitment | Data Management | Post Market Surveillance Copyright Š 2019 pepgra. All rights reserved
Challenges for Medical Device Manufacturers Medica l device manu f ac t ure rs are e x p e c t e d t o affect substantial alterations i n t e r m s of quality assurance , p r o d u c t d e v e l o p m e n t a n d d a t a reporting. E n f o r c e m e n t of t h e n e w M D R w o u l d m e a n h ig h e r cost i mp li c a t io n s a n d e x t e n d e d t i m e r eq uir ed for n e w p r o d u c t d e v e l o p m e n t . Th e p ro cess o f clinicalmonitoring
an d g at h erin g evid en c e fo r recert ificat io n
o f existing p r o d u c t s c o u l d also prove t o b e an expensive proposition.
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FOUR KEY CHALLENGES POSSED BY NEW MDR POSES FOR MEDICAL DEVICE MANUFACTURERS Clinical Research monitoring | Global Regulatory Writing | Patient Recruitment | Data Management | Post Market Surveillance Copyright © 2019 pepgra. All rights reserved
Major mo d if i c a t i o n s wi ll b e effected t o t h e classification of m e d i c a l devices.
In this case, r e q u i r e m e n t s w o u l d b e largely evaluated based o n risk it presents t o patients.
For instance, specific devices t h a t wi ll b e used o n spinal c o r d
RECLASSIFICATION
w i ll m o v e u p t h e order f r o m class II t o class III.
As a process, reclassification of devices w i ll have t o u n d e r g o expensive process of certification for n e w p r o d u c t s a n d also recertifying p r o d u c t s t h a t are already i n t h e market. The focus of t h e n e w M D R w o u l d shift f r o m approval of p r o d u c t t o its w h o l e lifecycle, w a r r a n t i n g h ig h e r clinical assessment prior t o approval.
This w o u l d n o d o u b t substantially slow d o w n t h e p r o d u c t i o n of m e d i c a l devices. Clinical Research monitoring | Global Regulatory Writing | Patient Recruitment | Data Management | Post Market Surveillance
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High Clinical Testing Needs A n o t h e r key challenge t h a t manu f ac t ure rs are c o n f r o n t e d w i t h pertains t o t h e increase i n r e q u i r e m e n t s for clinical testing. O w i n g t o reclassification, ma nu f ac t urers i n t h e past w h o we r e n o t req ui re d t o execute clinical testing, n o w n e e d t o b e able t o d o so. N e w regulations also necessitate a reevaluation of clinical d a t a p e r t a i n in g t o devices t h a t already exist i n t h e market. In t h e event t h a t t h e d a t a does n o t m a t c h t h e n e w requirements, m e d i c a l devices n e e d t o b e p u t t h r o u g h a d d it i o n a l testing for recertification. This f ur t her a u g m e n t s t h e cost of sustaining legacy devices .
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High Demand for Notified Bodies Not if ie d bodies (NBs) a c t e d as consultants in facilitating m e d i c a l device ma nu f ac t urers t o adh ere t o t h e r e q u i r e m e n t s for CE markings. W i t h t h e e n a c t m e n t of t h e n e w MDR, NBs w i ll assume t h e role of enforcers w h o w ill assess all m e d i c a l devices (other t h a n IVDs), those t h a t fall above class I. The shortage of NBs t o evaluate devices, specifically in devices classes t h a t are of h ig h e r risk, w il l lead t o a delay in approval for p r o d u c t s a n d slow t h e entry of a device i n t o t h e market. Timelines are b o u n d t o b e increased considering t h a t NBs have a h u g e v o l u m e of d a t a t o review. This i n turn, w o u l d t e n d t o increase costs o n t h e whole.
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Significance on Post Market Surveillance U n d e r t h e n e w MDR, m u c h stress is b e i n g laid u p o n p o s t - ma r k e t surveillance. This w o u l d c om p r i s e of p r e e m p t i v e m o n i t o r i n g of t h e p e r f o r m a n c e of m e d i c a l devices for yearly safety u p d a t e s for devices falling i n t h e h i g h risk class, recertification a n d p r o m p t r e p o rt i n g of incident s c o n c e r n i n g device safety. This k i n d of intense m o n i t o r i n g a n d re p o rt in g for safety requires a d d it io n a l resources w h i c h w o u l d prove t o b e a strain for m e d i c a l device manufacturers.
Clinical Research monitoring | Global Regulatory Writing | Patient Recruitment | Data Management | Post Market Surveillance
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Compliance The n e w M D R presents s o m e disruptive changes t h a t have far r eac hing i m p l i c a ti o n s for m e d i c a l device manufacturers . W i t h t h e transition p e r i o d a l m o s t at end , th e r e are several m o d if i c a t i on s t h a t device ma n u fa c tu r e r s n e e d t o enforce t o ensure success of existing a n d n e w devices . The e x t e n t a n d intricacy of t h e challen ge pr es ented b y t h e n e w M D R w o u l d require device m a n u fa c tu r e r s t o b r i n g a b o u t substantial changes i n d o m a i n s as vast as; d a t a reporting , p r o d u c t d e v e l o p m e n t , m a n u f a c t u r i n g procedures a n d q uality assurance . To c o m p l y w i t h t h e n e w MDR , device m an u fa c tu r e r s c a n strategize a n d c o n d u c t a g a p analysis t o identify w h e t h e r their existing devices c o m p l y w i t h t h e n e w MDR . Excellent leadership is vital t o facilitate t h e s m o o t h transition t o t h e n e w M D R w h i l e d ev e lo p in g a strategy for e x ec uti o n t h a t comprises of preset ti m e li ne s a n d te c h ni q u e s t o m o n i t o r progress w i t h regards t o c o m pl ia n c e .
Clinical Research monitoring | Global Regulatory Writing | Patient Recruitment | Data Management | Post Market Surveillance
Copyright Š 2019 pepgra. All rights reserved
Me dical device m an u fa c tu r e r s c o u l d s e tu p a core leadership t e a m t h a t w o u l d i n c l u d e experts f r o m q uality assurance , clinical or m e d i c a l affairs , R & D , regulatory affairs , m a n u f a c t u r i n g , labeling , b io c o m pa t ib il it y , sterilization a n d m a r k e ti ng . M e m b e r s of t h e t e a m n e e d t o establish a n active c o m m u n i c a t i o n w i t h NBs w h i l e setting pr oj e ct h a r m o n i z a t i o n b e t w e e n p r o d u c t portfolios a n d business units ( Premier Research , 2019). O n t h e o t h e r hand , m e d i c a l device m an u fa c tu r e r s are a p p r o a c h i n g external entities (Contract Research Organizations) t o acquire s u p p o r t a n d g u i d a n c e t o ensure c o m p l i a n c e ( Lehmann , 2019).
Clinical Research monitoring | Global Regulatory Writing | Patient Recruitment | Data Management | Post Market Surveillance
Copyright Š 2019 pepgra. All rights reserved
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