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KEYREQUIREMENTS F OR

MEDICAL DEVICE POST MARKET SURVEILLANCE w w w.v i s t a a r.a i


Presentation Outline TOPICS: Medical Device PMS Building a n Effective PMS Reactive (Incident-driven) PMS Proactive (Review-driven) PMS The FDA approach The EU approach

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Medical Device PMS The pos t- m arket surveillance(PMS) systems t h a t monitor m e d ic al device s afety after l a u n c h reduce both costs a n d d e m a n d s on resources a n d increase product s afety a n d performance. Before bringing m ed ic a l devices to market,manufacturers mus t minimize their risks a n d ensure patients' safety. This is monitored by authorities a n d notified bodies during authorization a n d conformity assessment procedure.

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Building an effective PMS As a medical device or IVD manufacturer, it is essential to ensure u p - t o - d a t e procedures for PMS to g uar ant e e regulatory compliance a n d avoid product recall. Building a PMS process, the first thing to do m a n a g e product safety a n d quality. This m a y include QA/RA, manufacturing, design, field s a l e s, a n d technical support. There are two types of PMS – reactive a n d proactive. Reactive is the most common approach used when setting u p a PMS system, but t hat doesn’t m e a n a proactive approach isn’t important. A good PMS system c a n become great by a d d i n g proactive measures to ensure only quality products are in the field.

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Reactive (Incident-driven) PMS: Part of this process will involve the m aint ena nce of risk m a n a g e m e n t files a n d a clear definition of the prompt events t h a t require further investigation of complaints. The e x a m p le s of reactive PMS are: Information a b o u t serious incidents, including field safet y corrective actions· Records referring to nonserious incidents a n d d a t a on a n y undesirable side effects · Information a n d actions from trend reporting · Information (including feedback a n d complaint) provided by users, distributors, a n d importers

Proactive (Review-driven) PMS: This c a n include m a n y nontraditional sources, such a s social m e d i a (e.g., Facebook a n d Twitter), online product reviews, online discussion forums, or bl o g s . As par t of PMS activities, h ave a p l a n or method for e va l u a t i n g this information. The e x a mp l es of proactive PMS are: Relevant specialist or technical literature, d a t a b a s e s , a n d / o r (patient) registers· Pu bl icl y a v a il a bl e inform a tion a bou t sim il a r m ed ica l d evices, su ch a s FDA’s Tota l Prod u ct Lif e Cycl e database· Information from other industries using the s a m e technology a s your device (e.g., network connectivity) Innova tions from you r com p etitors a nd introd u ction of a l terna tiv es to you r d evice, a s these l essen the clinical benefit of your device. w w w.v i s t a a r.a i


The FDA approach:

The EU approach:

Under section 5 2 2 of the Federal Food, Drug a n d Cosmetic Act in the S a f e Medical Devices Act of 1 99 0 (SMDA), the FDA is authorized to require manufacturers to conduct PMS for certain c la s s II a n d c la s s III m edic al devices. These are:

Post-market clinical follow up (PMCF) studies, detailed in the MEDDEV 2 .12/2 Rev 2 in Januar y 2012, are required for some devices that carry potential residual risks or need more clarity on long-term clinical performance , for example:

Devices where failure would h ave serious adverse h e a lt h consequences Devices th a t are im p l a n te d within the body for more t h a n one year Devices intended to be life- s u stain in g or lifesuppor ting being used outside a facility Devices expected to h ave significant use in pediatric populations Examples: infusion p u m p s (class II); i m p l a n t a b l e pacemakers (class III); a n d HIV diagnostic tests (class III). The FDA c a n require a surveillance period of u p to 36 months or longer, a n d manufacturers are required to comply with a n order for PMS within 1 5 months of receipt.

• Innovative products • Products that have undergone significant changes • High risks relating to the product, its anatomical location of use , or the patient population • Severity of disease • Unanswered questions concerning safety or performance • Issues with trial results, long-term safety, performance , adverse events, sur v eillance data • Emerging safety or performance data

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Key Requirements for Medical Device Post market Surveillance  

The post-market surveillance (PMS) systems that monitor medical device safety after launch reduce both costs and demands on resources and in...

Key Requirements for Medical Device Post market Surveillance  

The post-market surveillance (PMS) systems that monitor medical device safety after launch reduce both costs and demands on resources and in...

Profile for vistaarai
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