May 9, 2022 Regulatory Updates
LinkedIn

Medical Devices – USA/Europe Regulatory Updates Roundup, Apr 2022

EUROPE (EU)

The exercise of the power to adopt delegated acts conferred on the EC pursuant to Regulation (EU) 2017/745 on MD and Regulation (EU) 017/746 on in vitro diagnostic MD


Regulation (EU) 2017/745 of the European Parliament and of the Council on medical devices 1 and Regulation (EU) 2017/746 of the European Parliament and of the Council on in vitro diagnostic medical devices 2 were adopted on 5 April 2017 and entered into force on 25 May 2017. Regulation (EU) 2017/745 applies since 26 May 2021 3. Regulation (EU) 2017/746 will apply from 26 May 2022.

The Commission sees the need for a tacit extension of the delegations of power provided for in Article 115(2) of Regulation (EU) 2017/745 and Article 108(2) of Regulation (EU) 2017/746 for a period of five years, in accordance with those Articles. Officials said that an extension is needed because flexibility will be required as science advances and experience of the rules increases.

MDCG 2022-5 – Guidance on borderline between medical devices and medicinal products under Regulation (EU) 2017/745 on medical devices

The new MDCG guidance document clarify how developers can identify the correct regulatory framework for these so-called “borderline” cases by providing clear descriptions of various types of product and explaining how the differ. It also provides a flowchart that developers can use to determine if a product meets the definition of a medical device under the MDR.

According to the document, the flowchart is designed to help developers determine “whether a product fulfills the definition of a medical device per the MDR in order to ensure a consistent approach in the decisions concerning the borderline between medical devices and medicinal products.”

In the process of determining the conformity of protective equipment, the equipment is divided into 3 categories, where III is the most stringent. Category III includes hazards that can have very serious consequences, such as death or permanent damage to health in relation to (among the listed) substances and mixtures that are hazardous to health.

Due to the assigned Category III , masks for sale in the EU must be verified and certified by a Notified Body.

Notice to Stakeholders EU-Turkey Customs Union Agreement in the field of medical devices

The main purpose of this document is to provide guidance on the presentation, content and validation of the SSCP (Summary of safety and clinical performance). The SSCP is intended to provide public access to an updated summary of clinical data and other information about the safety and clinical performance of the medical device.

The establishment of the Customs Union of the EU and Turkey has been done gradually. Following Decisions Nos 1/95, 2/97 and 1/2006 of the ЕС-Turkey Association Council, the EU-Turkey Customs Union Joint Committee confirmed in its statements of 21 May 2021 and 13 September 2021 on the implementation of Decision 1/2006 of the ЕС Turkey Association Council that Turkish legislation is aligned with EU MDR and EU IVDR.

The two statements of 21 May 2021 and 13 September 2021 further confirm that “Whenever the EU instrument listed above [i.e. Regulations 2017/745 or 2017/746] and the relevant Turkish provisions giving effect to that instrument contain references to the territories of the Parties, the references shall, for the purpose of Decision No 1/95 of the ЕС-Turkey Association Council, be understood to comprise the territory of the EU Turkey Customs Union.”

In light of this, the following conclusions with regard to authorised representatives and notified bodies can be drawn

I. Authorised Representative
II. Notified Body

Update – Joint implementation and preparedness plan for Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR)

The Medical Device Coordination Group (MDCG) has updated its joint implementation and preparedness plan for the In Vitro Diagnostic Regulation (IVDR), adding sections on legacy devices and Eudamed in recognition of the need for guidance.

USA (FDA)

Refuse to Accept Policy for 510(k)s

The purpose of this document is to explain the procedures and criteria FDA intends to use in assessing whether a premarket notification (510(k)) submission meets a minimum threshold of acceptability and should be accepted for substantive review. Focusing FDA’s review resources on complete submissions will provide a more efficient approach to ensuring that safe and effective medical devices reach patients as quickly as possible.

Denture Base Resins – Performance Criteria for Safety and Performance Based Pathway

This guidance document provides the FDA’s recommendations on performance criteria to support premarket submissions for denture base resins in the Safety and Performance Based Pathway. Under this framework, submitters planning to submit a 510(k) using the Safety and Performance Based Pathway for denture base resins will have the option to use the performance criteria proposed in this final guidance to support substantial equivalence, rather than a direct comparison of the performance of the subject device to that of a predicate device. The recommendations are intended to promote consistency and facilitate efficient review of denture base resins submissions.

Facet Screw Systems – Performance Criteria for Safety and Performance Based Pathway

This guidance document provides the FDA’s recommendations on performance criteria to support premarket submissions for facet screw systems in the Safety and Performance Based Pathway. Under this framework, submitters planning to submit a 510(k) using the Safety and Performance Based Pathway for facet screw systems will have the option to use the performance criteria proposed in this final guidance to support substantial equivalence, rather than a direct comparison of the performance of the subject device to that of a predicate device. The recommendations are intended to promote consistency and facilitate efficient review of facet screw systems submissions.

Orthopedic Fracture Fixation Plates – Performance Criteria for Safety and Performance Based Pathway

This guidance provides performance criteria for Orthopedic Fracture Fixation Plates in support of the Safety and Performance Based Pathway. Under this framework, submitters (you) planning to submit a 510(k) using the Safety and Performance Based Pathway for Orthopedic Fracture Fixation Plates will have the option to use the performance criteria proposed in this guidance to support substantial equivalence, rather than a direct comparison of the performance of the subject device to that of a predicate device.

Surgical Sutures – Performance Criteria for Safety and Performance Based Pathway

This guidance provides performance criteria for surgical sutures in support of the Safety and Performance Based Pathway. Under this framework, submitters (you) planning to submit a 510(k) using the Safety and Performance Based Pathway for surgical sutures will have the option to use the performance criteria provided in this guidance to support substantial equivalence, rather than a direct comparison of the performance of the subject device to that of a predicate device.

ROW – BRAZIL (ANVISA)

ANVISA has updated Good manufacturing Practices for Medical devices and IVDS

Anvisa RDC 665/2022 Provides for Good Manufacturing Practices for Medical Products and In Vitro Diagnostic Products replaces previous regulations including RDC 16/2013 and IN 08/2013 and comes effect in May2, 2022.

ANVISA has updated regulation of Software as medical device

ANVISA has published New regulation for software as medical device which will take effect in July 2022.
RDC NO. 657, OF MARCH 24, 2022 that Provides the regulation of software as a medical device (Software as a Medical Device – SaMD).

Tags:

Browse by Topic