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MDR 2017/745 Implementation: Are you prepared?

19.05.2021

Are you a medical device manufacturer? Then be prepared for the Medical Devices Regulation (MDR).

The new Regulation, which will be in force in May 2021, introduces significant changes for manufactures, importers and distributors to comply with in order to obtain the CE marking and enter the EU market. Find out in detail more about all the new developments and get ready for MDR.

On 5 May 2017 the European Economic Community (EEC) officially published the new regulations:

MDR covers a broader product scope, while the classification of the medical device remains crucial: MDR contains 22 rules for classification, contrary to the 18 rules in MDD. Get all the updates and requirements introduced by the new Regulation.

Please do not forget to examine the basic steps for certifying medical devices which manufacturers need to take in order to carry out the conformity assessment procedure of a medical device.

How can we help you?

Certification Company is an independent medical device consultancy. Our team will provide you with all the relevant information. Over the years, we have proudly rendered our assistance to many manufacturers and importers!

Our services

Carry out MDD-MDR Gap Analysis;
Implement EN-ISO 14971 for medical device risk management;
Perform product testing in accordance with EN 60601 standards;
CE marking of medical device software (Software as a Medical Device in accordance with EN 62304 and/or EN 82304;
Implement and maintain a Quality Management System (QMS) in accordance with EN-ISO 13485:2016;
Draw up (post-market) clinical evaluations;
Assessment of general safety and performance requirement;
Establish post-market surveillance and vigilance system;
Provide assistance during registration of medical devices (UDI) and economic operators in EUDAMED;
Operate on your company’s behalf as the European Authorized Representative and/or Person Responsible for Regulatory Compliance.

Advice needed?

Feel free to contact one of our experts:
By phone: +31 (0)36 202 40 12
By e-mail or via our contact form.

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