May 26 is the effective date of the EU Medical Device Regulation (EU MDR).  Redica Systems GMP Medical Device Expert Mark Agostino answered a few questions about the regulation and what medical device manufacturers need to know.  Mark is the latest addition to our team of industry experts.

In Part II of this two-part interview, he discusses digital health and other FDA trends around medical devices.

In general, do you think medical device manufacturers are prepared for the May 26 EU MDR implementation date?

Generally speaking, there is still a fair level of uncertainty in the industry.  Not many devices have been certified against EU MDR so there is not a great amount of data upon which companies can refer to.  The EU MDR has changed the game for manufacturers trying to get their devices into the EU market.  One of the most impactful for manufacturers is the role of the Notified Bodies.

Under 93/42/EEC MDD, Notified Bodies could act in a consulting capacity to assist manufacturers in addition to granting a CE certification for medical devices distributed in the EU market.  Under EU MDR 2017/745, Notified Bodies are not allowed to provide consulting assistance after May 26, 2021.  As a result, this leaves manufacturers to do their best to interpret the regulations which have added a layer of difficulty. 

Also, EU MDR is now a regulation versus MDD which is only a directive.  EU MDR is more prescriptive in a number of requirements (e.g., labeling and postmarket surveillance) that manufacturers will now have to adhere to since EU MDR is a regulation. 

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There is a lot of concern about the shortage of Notified Bodies ahead of the May 26 date. How do you anticipate EU authorities responding?  

The European Commission is trying to certify as many Notified Bodies prior to the effective date.  To date, there are 19 Notified Bodies that have certified to EU MDR 2017/745.  Before the EU MDR was released in 2017, at one point, there were more than 70 Notified Bodies able to CE certify medical devices as a point of comparison according to MDD.

There are going to be challenges for the industry in bringing devices to market for two reasons: 1) the relatively limited number of Notified Bodies, and 2) the breadth of the EU MDR to be evaluated against which will introduce long lead times to complete CE certification.

Currently, it is not unreasonable to expect that it will take six to 12 months to adhere to an MDR-compliant CE certification process toward bringing medical devices to the EU market.

What should medical device manufacturers marketing products to the EU do to prepare?

One of the first challenges is to secure a contract with a Notified Body.  Doing the research to establish a relationship with a Notified Body who has experience in certifying similar devices will be beneficial.  The learning curve for the Notified Body will not be as great in understanding the technology seeking to be introduced into the EU market.

Understanding the breadth of the requirements noted in EU MDR will be important and will require manufacturers to prepare as soon as possible to meet the necessary requirements. Understanding the state of the art for your technology will be important in evaluating the risk-benefit profile for your technology.  ISO 14971:2019, MEDDEV 2.7.1 Rev 4, and EU MDR all reference state of the art.  ISO 14971:2019 actually defines the term.  Notified Bodies are interested in understanding how manufacturers have evaluated and incorporated state of the art in their device designs.

Should device manufacturers anticipate similar regulations in the U.S. and other markets?  

For the most part, the regulations in EU MDR are on par with the FDA Quality System Regulation (QSR).  Regulations in other markets will mirror requirements stipulated in either EU MDR or FDA QSR for the most part.

The FDA’S Medical Device Single Audit Program (MDSAP) program is an effort to harmonize inspection requirements with the regulations for multiple countries.  If a member of MDSAP inspects a site, then the other members of MDSAP can utilize that inspection report for evaluating the approval/clearance of a medical device.  It will be interesting to see how this program evolves going forward to include more members.

About the Expert

Mark Agostino

Mark Agostino is Managing Director of QARA Biomed. His areas of expertise include quality assurance and regulatory affairs for medical device and combination products. He provides guidance to Sponsors and Contract Service Providers with meeting DHF and Technical File requirements, risk management, supplier quality processes, audits, preparing regulatory submissions, and ensuring compliance to global standards and regulations.

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