What Pharma Companies need to know about EU MDR Regulations?

EU MDR

• The Medical Device Regulation (MDR), which was adopted in April 2017, changes the European legal framework for medical devices
• The EU MDR entered into application on 26 May 2021
• REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017
• Over the 20 years the first major change was the EU MDR and IVDR which replaces by existing MDD.
• MDD certificates will be valid until their original expiry date or 26 May 2024
• EU MDR entirely applicable to the 27 EU Member countries.

Scope:

• Every manufacturer, authorized representative, importer or distributor of medical devices in the EU or a regulatory affairs or quality management professional involved with medical devices should comply with the EU MDR Regulations.
• This Regulation lays down rules concerning putting into service of medical devices for human use and accessories for such devices in the Union market.
• This Regulation also applies to clinical investigations conducted in the Union.
• Clinical evidence need to be updated on time and also publically available.
• Devices with both a medical and a non-medical intended purpose shall fulfill cumulatively
• Medical Devices must undergo conformity assessment to meet legal requirements and manufacturers can place a CE mark on it after assessment.
• Designated notified bodies by EU member states will conduct conformity assessment and issues CE certificate.
• EMA mainly provides scientific opinions to notified bodies through consultation procedures
• When medicines are used in combination with medical device then the entire product is regulated under the EU Pharmaceutical Legislation.
• Necessary to maintain all EU countries under one regulation to avoid differentiation among all member countries.
• EU MDR regulations are intended to improve safety, performance and also provide protection of the users.
•  Regulation covers the wide range of products
• Medical device coordination group (MDCG) decides case by case basis whether or not a specific product, category or group of products falls within the scope of this regulation.
• European Medicines Agency (EMA), the European Chemicals Agency and the European Food Safety Authority also ensures the level of consultation for the border line products which consists of medicinal products, biological products, cells, human tissues and food products.
• In some cases the European parliament and the council gives union wide decision regarding regulatory status of the product.
• The scope of application of this Regulation should be clearly delimited from other Union harmonization legislation concerning products, such as in vitro diagnostic medical devices, medicinal products, cosmetics and food.
• All relevant regulatory information for medical devices will store and maintain in the EUDAMED (database), not a public database but it maintain, facilitate information to exchange between the European Commission and competent authorities in the EU states.

Compliance:

• For manufacturers who are not established in the Union, the authorized representative plays a pivotal role in ensuring the compliance of the devices.
• The authorized representative responsible for regulatory compliance.
• General safety and performance requirements and other legal requirements shall be compliance with harmonized standards.
• Quality management system shall address the strategy for regulatory compliance, including compliance with conformity assessment procedures and procedures for management of modifications to the devices covered by the system
• Manufacturers need to clear the obligation in compliance with respect to Quality management, Risk Management, Clinical evaluation, Technical documentation and conformity assessment procedures.
• Every product may have its own compliance tasks as well so the authorized person need to clear issues in each & every steps.

Key Timelines:

• Entry into force of the EU MDR – 26th May 2017
• Earliest date EUDAMED can go live – 26th Mar. 2021
• Date of application of the EU MDR – 26th May 2021
• Notified Body certificates issued under MDD designation become void i.e. the last possible date for placing devices on the market according to the MDD – 26th May 2024
• Last possible date for putting devices into service according the MDD – 26th May 2025
• Until 25th May 2024, devices in conformity with the MDR can be certified under the MDR and placed on the market.
• Until 25th May 2024, devices in conformity with the MDR can be certified under the MDR and placed on the market

Key Requirements:

• Annex I specifies the safety and performance requirements
• Annex II specifies the requirements of certain technical documentation
• Manufacturer can approach in different ways
  • Annex IX: a conformity assessment (by a notified body)
  • Annex X, production is audited, and a representative sample of production is tested and as described in Annex XI, Part A – excluding the design & verification activities
  • Annex X, production is audited, and a representative sample of production is tested and as described in Annex XI, Part B – Complete on product conformity (based on 100% testing) Ex. Small batches
• Annex IV requirements for the declaration of conformity
• Annex V requirements for the CE mark.

Key Steps:

• Decision – Usage, classification of medical device
• Necessary process and resource documents establishment
• Fulfillment of general safety, performance requirements and to avoid or minimize the risks
• Clinical Evaluation process
• Technical Documentation process
• Registration
• Conformity process
• Final Administrative procedures
• Distribution
• Ongoing obligations from the post launch phase.

Stay ahead of EU MDR regulations. Ensure compliance for your medical devices. Contact us today for expert guidance and support.